Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 343

Defendants' Reply in Opposition to Amgen Inc.'s Claims Construction Brief [DN 323] - LEAVE TO FILE GRANTED ON 3/30/07 Response by F. Hoffmann-LaRoche LTD, Roche Diagnostics GmbH, Hoffmann LaRoche Inc. to #323 Response,,,,,. (Attachments: #1 Index of Exhibits#2 Exhibit RR#3 Exhibit SS (part 1)#4 Exhibit SS (part 2)#5 Exhibit TT#6 Exhibit UU#7 Exhibit UU-1#8 Exhibit UU-2#9 Exhibit UU-3)(Rizzo, Nicole)

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EXHIBIT UU-1
Revised 12/19/06

CURRICULUM VITAE
PATRlCK P. DELUCA, Ph.D.
3292 Nantucket Drive, Lexington, Kentucky 40502 859/277-9477(Home) 859/257-1831(Work) Email: [e-mail] PRESENT POSITION: Professor, Faculty of Pharmaceutical Sciences, University of Kentucky College of Pharmacy, 725 Rose Street, Suite 327H, Lexington, KY 40536-0082 PERSONAL DATA: Birthdate - September 7, 1935, Scranton, PA Wife - Judy; 6 children (Paul, Thomas, Patrick, Donald, Michelle, Michael) EDUCATION: Temple University, Philadelphia, PA B.S. in Pharmacy - June 1957 M.S. in Pharmacy - June 1960 Thesis: "The Interaction of Quaternary Ammonium Compounds with Nonionic Macromolecules" Ph.D., Pharmaceutical Sciences - January 1963 Dissertation: "Photobinding and Photoreactivity of Riboflavin in the Presence of Macromolecules" PROFESSIONAL EXPERIENCE: University of Kentucky College of Pharmacy
1998 - 2000 1975 - Present 1987 - 1988 1978 - 1987 1972 - 1984 Interim Chair, Faculty of Pharmaceutical Sciences Professor Acting Director, Center for Pharmaceutical Science and Technology Associate Dean Division Director Pharm. Tech. Div. 1972-75, Drug Information & Technology 76-81, Drug Information, Evaluation & Technology 81-83, Clinical Practice 83-84. Assistant Dean Associate Professor
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1971 - 1978 1970 - 1975

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Industry 1969 - 1970 Cormedics Corporation, Somerville, N.J. Plant Manager 1969, Director Development and Control 1970. This was a joint venture between CIBA Pharmaceutical Co. and Coming Glass Co which developed and manufactured a unit dose injectable system. 1963 - 1969 CIBA Pharmaceutical Co., Summit, N.J. Senior Research Pharmacist - January 1963 to May 1966. Manager, Special Projects - May 1966 to Nov. 1966. Plant Manager, Somerville, N.J. Operations, Nov. 1966 to February 1969. (Operations later became Cormedics Corp.) 1957 - 1959 Other 1961 - 1962 Temple University, College of Pharmacy, Philadelphia, PA Laboratory Instructor (1961), Research Associate (1962). 1959 - 1961 1954 - 1957 1952 - 1954 Relief Pharmacist, Street Road Pharmacy, Cornwell Heights, PA. Pharmacy Technician, Eppleys Pharmacy, Philadelphia, PA Pharmacy Technician, Jenkins Pharmacy, Scranton, PA. Analytical Chemist, Smith Kline & French Labs, Philadelphia, PA.

TEACHING AND RESEARCH INTERESTS: Pharmaceutical Technology, Sterile Products, Intravenous Administration Systems, Controlled Drug Delivery, Target Drug Delivery, Dosage Form Development and Formulation of Proteins. (course involvement listed in ADDENDUM) ASSOCIATIONS: American Association of Pharmaceutical Scientists American Pharmaceutical Association Academy of Pharmaceutical Sciences American Association of Colleges of Pharmacy Kentucky Pharmacists Association Parenteral Drug Association American Society of Hospital Pharmacy New York Academy of Sciences Scientific Research Society of America - Sigma Xi Rho Chi Pharmaceutical Honor Society American Society for Parenteral & Enteral Nutrition Kentucky Academy of Sciences Controlled Release Society
AWARDS RESULTING FROM RESEARCH AND SCHOLASTIC ACHIEVEMENT:
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Leo G. Penn Memorial - Temple University 1957 Walter G. Karr Fellowship - Smith, Kline and French Laboratories 1959-1962. Lunsford-Richardson Pharmacy Award - "The Inactivation of Cationic Pharmaceuticals by Nonionic Surface Active Agents" 1960. Lunsford-Richardson Pharmacy Award - "The Effect of Binding on the Photochemical Properties of Hydrocortisone and Methylprednisolone" 1962. Best paper during the year 1965 toward the scientific advancement of Industrial Pharmacy. Recognized by the North Jersey Pharmaceutical Research Discussion Group. Co-author and faculty advisor of award winning papers submitted by graduate students to the Parenteral Drug Association for the years 1972, 1973, 1976 and 1977. Research Achievement Award for 1975 - Parenteral Drug Association Recognition for outstanding contribution to the literature in advancing the area of parenteral technology. (First Recipient) ASHP Research Award (principal author) for the most significant contribution to the literature of research in the professional practice of hospital pharmacy during 1975 for the article "Filtration and Infusion Phlebitis: A Double-blind Prospective Clinical Study". Stimulation of Research Awards for 1981 and 1982 from Parenteral Drug Association "Interaction of Microspheres with Blood Constituents and Effect on Immune Response". Outstanding Educator in the U.S. - 1973-74. Listed in American Men and Women of Science, Who's Who in America, Who's Who in the South and Southwest, Who's Who in Medicine and Healthcare, Who's Who in Science and Engineering and Who's Who in American Education. Research Award with graduate student from Parenteral Drug Association Foundation for the Parenteral Sciences for 1986 to study the "Effects of Freezing and Drying on Immunoglobulin Conformation". Research Achievement Award in Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (1988). (First Recipient) Certificate of Honor Award as a Distinguished Alumni of Temple University (1989). Named a Senior Fellow with the Institute for Advanced Biotechnology (1991). William B. Sturgill Award for outstanding contribution to graduate education and research: University of Kentucky (1995). Outstanding Manuscript Award in Pharmaceutical Development and Technology (1998) for publications during 1996 and 1997. Named a Fellow of the American Association of Indian Pharmaceutical Scientists (1998). Mentor of graduate student (Harmeet Chadha) receiving AAPS Graduate Student Award for Outstanding Manuscript (1998). Mentor of graduate student (Jay Schrier) receiving AAPS Graduate Student Award for Outstanding Manuscript (1999). AAPS Outstanding Educator Award in Pharmaceutical Sciences (2000). (First Recipient) Mentor of two graduate students (Janusz Kostanski and Sisay Gebrekidan) receiving AAPS Graduate Student Awards for Outstanding Manuscripts (2000). Mentor of graduate student (Bhas Dani) receiving AAPS Graduate Student Award for Outstanding Manuscript (2001). Sullivan Medallion Award: University of Kentucky (2001). Mentor of graduate student (Ge Jiang) receiving AAPS Graduate Student Award for Outstanding Manuscript (2002) Kentucky Pharmacist of the Year (2002). Outstanding Manuscript Award in Pharmaceutical Technologies for Publications in AAPS Journals (2002) for publications in 2000 and 2001. Mentor of graduate student (Santos Murty) receiving AAPS Graduate Student Award for Outstanding Manuscript (2003). Swintosky Distinguished Lecturer, University of Kentucky College of Pharmacy (2003). Mentor of visiting scholar (Stefano Giovagnoli) receiving AAPS Graduate Student Award for Outstanding Manuscript (2004).
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Mentor of graduate student (Susan D'Souza) recipient of AAPS Graduate Student Award for Outstanding Manuscript (2005). Honorary Doctorate from University of Perugia, Italy May 30, 2006. AAPS Dale Wurster Research Achievement Award in Pharmaceutics (2006) Outstanding Manuscript Award in AAPS PharmSciTech Journal (2006) for publication during 2004 & 2005 PUBLICATIONS: Chapters in Textbooks: 1) "Kinetic Principles and Stability Testing", The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia, PA (1970) pp 669-710. Second revision (1976), Third Revision, pp 760-803, (1986). "Sterile Products", American Pharmacy Textbook, 7th edition, Lippincott, Philadelphia, PA, pp 451-491 (1974). "Parenteral Drug Delivery Systems" in Pharmaceutics and Pharmacy Practice, 1st ed., p. 238, Philadelphia, J.P. Lippincott (1982). "Formulation of Small Volume Parenterals," in Pharmaceutical Dosage Forms: Parenteral Medications, Vol. 1, pp. 139-201, Marcel Dekker Inc., N.Y. (1984). Second Edition, Vol. 1, pp. 173-248, Marcel Dekker Inc., N.Y. (1992). "Particulate Matter Monitoring" in Pharmaceutical Dosage Forms: Parenteral Medications, Vol. II, Marcel Dekker, Inc., NY, pp. 217-308, (1986). "Particulate Matter" in Pharmaceutical Dosage Forms: Parenteral Medications, Second Edition, Vol. III Marcel Dekker, Inc., N.Y., pp. 117-230 (1993).

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Articles in Professional Journals: 1) A Description of Some Self Evaluation Programs and Case Histories, DeLuca, P., Presented at the Conference on Drug Efficacy Evaluation and Self Evaluation by Pharmaceutical Industry, October 1971. Published in the "Wisconsin Pharmacist , (1972) and FDA Handbook, "Introduction to Total Drug Quality," DHEW Publication No. (FDA) 74-3006, Nov. 1973. Real Life Settings Make Training in Pharmacy Practical and Useful, DeLuca, P., Hopkins, H. and Smith, H., Pharmacy Times, 44-48, March (1972). Issue Identification Approach to Pharmacy Education Planning I. Overview of Some Major Issues, Barnett, R.L., Butler, H.L., DeLuca, P.P., and Straus, R., American Journal of Pharmaceutical Education, 40:71-74, Feb. (1976). Tomorrow's Pharmacists Today through Role Modification, Barnett, R.L., Butler, I.L., DeLuca, P.P., and Straus, R., Pharmacy Times 69968-74, Oct. (1976). Minimizing Contamination During I.V. Therapy by In-line Filtration, DeLuca, P.P., Rapp, R.P., and Bivins, B., Western States I.V. Therapy Journal, 5-14, Sept.-Oct. (1976).
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Drug Information in Pharmacy Practice, Amerson, A.B., Barnett, R.L., Butler, I.L., and DeLuca, P.P., J. Clin. Pharm., 2:219-225(1978). Pharmaceutical Technology Clerkship, A Professional Elective Course at the University of Kentucky, Im, S., and DeLuca, P.P., Am. J. Pharm. Education, 42:52-55 (1977). Pharm.D. in Industry, Proceedings at a special American Association of Colleges of Pharmacy Convention, Seattle, Washington, August 7, 1977. Published by Hoffman-LaRoche, Inc., 1978. Filtration and Infusion Therapy: A Review and Forecast for the 80's. Rapp, R.P., Bivins, B. and DeLuca, P.P., Am. J. I.V. Ther. Clin. Nutr., 7:36-46 (1980). Bridging the Gap Between the Basic Sciences and Clinical Practice: Teaching, Research and Services. The Importance of Defining Institutional Goals. Swintosky, I.V., DeLuca, P.P., Parker, P.F., and Gueryant I., Am. J. Phar. Ed., 45:109-117 (1981). Microcontamination Control: An Approach to Training. DeLuca, P.P., J. Paren. Sci. and Tech., 37(6):218, (1983). Controlled Release: A Clinical Guide. Pullins, Leanne and DeLuca, P.P., Merck Minutes, 3(1):1, 1986. Let's Harmonize: Guest Editorial, DeLuca, P.P., J. Paren. Sci. and Tech., 44 (4), 183, 1990. Educational Issues Related to the Science and Technology of Sterile Products: Academic and Industrial Perspectives. Allen Jr., L.V., Bloss, C.S., Brazeau, G.A., DeLuca, P.P., Raymond, G.G., Robinson, D.H., Stiles, L. and Thiboutot, R.P., Am. J. Pharm. Ed., 57:257-265 (1993). Educational Issues Related to the Science and Technology of Sterile Products: Strategies for Education. Allen Jr., L.V., Bloss, C.S., Brazeau, G.A., DeLuca, P.P., Raymond, G.G., Robinson, D.H., Stiles, L. and Thiboutot, R.P., Am. J. Pharm. Ed., 57:265-268 (1993). Regulatory and Ethical Issues of Gene-Based Drugs, DeLuca, P.P., 10th International Pharm Tech Symposium, in press, Minutes, Editions De Sante, Paris, (2001).

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Articles in Scientific Journals: 1) 2) A Note on an Infrared Assay of Chloroform in Pharmaceutical Products, Souder, J.C. and DeLuca, P.P., J. Am. Pharm. Assoc., Sci Ed 49, 225 (1960). Interaction of Preservatives with Macromolecules I.V. Binding of Quaternary Ammonium Compounds by Nonionic Agents, DeLuca, P.P. and Kostenbauder, H.B., J. Am. Pharm. Assoc., Sci Ed 49, 430 (1960). Reversible Photobinding of Riboflavin to Macromolecules in Aqueous Solution, DeLuca, P.P. and Kostenbauder, H.B., J. Phys. Chem., 67, 1395 (1963). Enhanced Photoreactivity of Riboflavin in Aqueous Solution in the Presence of Macromolecules, DeLuca, P.P. and Kostenbauder, H.B., Nature, 199, 999 (1963). Binding of Organic Electrolytes by a Nonionic Surface Agent, Hurwitz, A., DeLuca, P.P., Kostenbauder, H.B., J. Pharm. Sci., 52, (1963).
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Lyophilization of Pharmaceutical I. Effect of Certain Physical-chemical Properties, DeLuca, P.P. and Lachman, L., J. Pharm. Sci., 54, 617 (1965). Lyophilization of Pharmaceuticals II. High-Sensitivity Resistance Bridge for Low-Conductivity Measurements at Eutectic Temperatures, Lachman, L., DeLuca, P.P., Withnell, R., J. Pharm. Sci., 54, 1342 (1965). Lyophilization of Pharmaceuticals III. Programming of Mathematical Expression of Estimating Eutectic Temperatures from Melting Point and Solubility Parameters, DeLuca, P.P., Lachman, L., Yost, W., J. Pharm. Sci., 54, 1348 (1965). Lyophilization of Pharmaceuticals IV. Determination of Eutectic Temperatures of Inorganic Salts, DeLuca, P.P. and Lachman, L., J. Pharm. Sci., 54, 1411 (1965). Lyophilization of Pharmaceuticals V. Influence of Metal Trays on Health Transfer During Lyophilization, DeLuca, P.P. and Lachman, L., Bull. Parenter. Drug Assoc., 20, 65 (1966). Photobinding and Photoreactivity of Riboflavin in the Presence of Macromolecules, Kostenbauder, H.B., DeLuca, P.P., Kowarski, C.R., J. Pharm. Sci., 54, 1244 (1965). Modified Computer Programs for Determining Eutectic Temperatures, DeLuca, P.P., Lachman, L., Yost, W., Clements, I.A., Rogers, A.R., J. Pharm., Sci., 55, 450 (1966). Manufacturing Aspects of Prefilled Disposable Syringes, DeLuca, P.P., Bull. Parenter. Drug Assoc., 23, 8 (1969). Nylon as a Dialysis Membrane, Kostenbauder, H.B., Boxenbaum, H.G., DeLuca, P.P., J. Pharm. Sci., 58, 753 (1969). Instrumented Pilot Plant Lyophilizer: Its Versatility in Developing and Programming Production Cycles, DeLuca, P.P., J. Pharm. Sci., 60, 744-81 (1971). Problems Arising from the Transfer of Sodium Bicarbonate Injection from Ampuls to Plastic Syringes, DeLuca, P.P. and Kowalsky, R.I., Am. J. Hosp. Pharm., 29, 217 (1972). In-line Final Filtration - A Method of Minimizing Contamination in Intravenous Therapy, Ryan, P.B., Rapp, R.P., DeLuca, P.P., Griffen, W.O., Clark, I.D., Cloys, D., Parenteral Drug Association Research Award winning paper for 1972, Bull. Parenter. Drug Assoc., 27, 1 (1973). Physical-Chemical Properties of Substituted Amides in Aqueous Solutions and Evaluation of Their Potential Use as Solubilizing Agents, DeLuca, P.P., Lachman, L., Schroeder, H.G., J. Pharm. Sci., 62,1320-27 (1973). A Study on the In-vitro Precipitation of Poorly Soluble Drugs From Nonaqueous Vehicles in Human Plasma, Schroeder, H.G. and DeLuca, P.P., Parenteral Drug Association Research Award winning paper for 1973, Bull. Parenter. Drug Associ. 28, 1 (1974). Consequences of Microbial Contamination During Extended Intravenous Therapy Using In-line Filters, Rusmin, S., Althauser, M.B., DeLuca, P.P., Am. J. Hosp. Pharm., 32, 373-77 (1975). Effect of Antibiotics and Osmotic Change on the Release of Endotoxin by Bacteria Retained on Intravenous In-line Filters, Rusmin, S. and DeLuca, P.P., Am. J. Hosp. Pharm., 32, 378-80 (1975). In-line Filtration of I.V. Fluids and Drugs, Rapp, R.P., Bivins, B., DeLuca, P.P., Am. J. of IV Ther., 2, 18-23 (1975).
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Filtration and Infusion Phlebitis: A Double-blinded Prospective Clinical Study, DeLuca, P.P., Rapp, R.P., Bivins B., McKean, H.E., Griffen W.O., Am. J. Hosp. Pharm., 32,1001-1007 (1975). Viscosities and Partial Molal Volumes of Some Tetramethylcarboxamides at 25°C, DeLuca, P.P. and Rebagay, T.V., J. Phys. Chem., 79, 2493-96 (1975). Evaluation of a Prototype Air-venting In-line Intravenous Filter Set, Rapp, R.P., Bivins, B., Schroeder, H.G., DeLuca, P.P., Am. J. Hosp. Pharm., 32, 1253-59 (1975). Membrane Filters: Additional Safety for Intraarterial Infusions, Meeker, W.R., Rapp, R.P., DeLuca, P.P., Bivins, B., Arch. Surg., 111, 201 (1976). Effect of In-line Intravenous Filtration on the Potency of Potassium Penicillin G, Rusmin, S. and DeLuca, P.P., Bull. Parenter. Drug Assoc., 30, 64-71 (1976). Evaluation of a 5 Micron Stainless Steel Filter as an Intravenous In-line Filter or Pre-filter, Rapp, R.P., Schroeder, H.G., DeLuca, P.P., Am. J. Hosp. Pharm., 33, 52-356, (1976). Residues in Antibiotic Preparations I. Scanning Electron Microscopic Studies of Surface Topography, Rebagay, T., Rapp, R.P., Bivins, B., DeLuca, P.P., Am. J. Hosp. Pharm., 33, 433-43 (1976). Residues in Antibiotic Preparations II. Effect of pH on the Nature and Level of Particulate Matter in Sodium Cephalothin Intravenous Solution, Rebagay, T. and DeLuca, P.P., Am. J. Hosp. Pharm., 33, 443-48 (1976). Particulate Matter Assessment of a Clinical Investigation on Filtration and Infusion Phlebitis, Schroeder, H.G. and DeLuca, P.P., Am. J. Hosp. Pharm., 33, 543-46 (1976). Compliance with USP Osmolarity Labeling Requirements, Murty, B.S.R., Kapoor, I.N., DeLuca, P.P., Am. J. Hosp. Pharm., 33, 546-51 (1976). The Dielectric Constant and Dipole Moment of N,N,N'N' Tetramethylpimelamide at 25oC., DeLuca, P.P., Rebagay, T.V., Casteel, I., J. of Chem. & Engr. Data, 21, 262-64 (1976). Correlation of Dielectric Constant and Solubilizing Properties of Tetramethyldicarboxamides, Rebagay, T. and DeLuca, P.P., J. Pharm. Sci., 65(11), 1645-48 (1976). Microbial Assessment of a Clinical Investigation on Filtration and Infusion Phelebitis, Rusmin, S., DeLuca, P.P., Rapp, R., Bivins, B., 1976 Parenteral Drug Association Research Award, Bull. Parenter. Drug Assoc., 31(1), 1-8 (1977). Freeze Drying of Pharmaceuticals, DeLuca, P.P., J. Vac. Sci. & Technol., 14, 620-29 (1977). Particulate Matter Monitoring I. Evaluation of Some Membrane Filters and Microscopic Techniques, Rebagay, R.V., Schroeder, H.G., Sophann, I.M., DeLuca, P.P., Bull. Parenter. Drug Assoc., 31(2), 57-69 (1977). Particulate Matter Monitoring II. Correlation of Microscopic and Automatic Counting Methods, Rebagay, T.V., Schroeder, H.G., DeLuca, P.P., Bull Parenter Drug Assoc., 31(3), 150-55 (1977). Inflammatory Potential of Foreign Particulates in Parenteral Drugs, Dorris, G. C., Bivins, B.A., Rapp, R.P., Weiss, D.L., DeLuca, P.P., Ravin, M.B., Anesth. Analg., 56(3), 422-28 (1977).
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Effect of In-line Filtration on the Potency of Drugs Administered Intravenously, Rusmin, S., Welton, S., DeLuca, P., DeLuca, P.P., Am. J. Hosp. Pharm., 34, 1071-74 (1977). Research and Development of Pharmaceutical Dosage Forms, International Symposium on Freeze-drying of Biological Products, Washington, DC, 1976, DeLuca, P.P., Develop. Biol. Standard, 36, 41-50 (1977). Improved Microscopic Methods and Correlation with Automatic Methods, Part 4 of a panel presentation on Particulate Contamination Monitoring, DeLuca, P.P., Bull. Parenter. Drug Assoc., 31(4), 173-78 (1977). The Detection of Ampul Leakers Using Short-lived Radioisotope, Butler, L.D., Coupal, I.I., DeLuca, P.P., 1977 Parenteral Drug Association Research Award, Bull, Parenter Drug Assoc., 32(1), 2-9 (1978). Sustained-Release From Inert Wax Matrixes I: Drug-Wax Combinations, Schroeder, H.G., Dakkuri, A., DeLuca, P.P., J. Pharm. Sci., 67(3), 350-53 (1978). Sustained Release from Inert Wax Matrixes II: Effect of Surfactants on Tripelennamine Hydrochloride Release, Dakkuri, A., Schroeder, H.G., DeLuca, P.P., J. Pharm. Sci., 67:(3), 354-57 (1978). Sustained Release from Inert Wax Matrices III: Effect of Povidone on Tripelennamine Hydrochloride Release, Dakkuri, A., Butler, L.D., DeLuca, P.P., J. Pharm. Sci. 67:(3), 357-360 (1978). Distribution of Radiolabeled Subvisible Microspheres after Intravenous Administration to Beagle Dogs, Schroeder, H.G., Simmons, G.H., DeLuca, P.P., J. Pharm. Sci., 67 (4), 504-07 (1978). Physiological Effects of Subvisible Microspheres Administered Intravenously to Beagle Dogs, Schroeder, H.G., Bivins, B.A., Sherman, G.P., DeLuca, P.P., J. Pharm. Sci., 67(4), 508-13 (1978). A Note on the Acute Toxicity of Substituted Amide Solvents, Sherman, G.P., Gatlin, L., DeLuca, P.P., Drug Dev. Ind. Pharm., 4(5), 485-89 (1978). Final In-line Filtration: A Means of Decreasing the Incidence of Infusion Phlebitis, Bivins, B.A., Rapp, R.P., DeLuca, P.P., McKean, H., Griffen, W.O., Surgery, 85(4), 388-94 (1979). Conditions Permitting Air Flow Through an Air-venting In-line Filter, Rusmin, S., Rapp, R.P., Bivins, B.A., DeLuca, P.P., Am. J. Hosp. Pharm., 36, 749-53 (1979). Colorimetric Determination of Penicillins and Related Compounds in I.V. Solutions by Nickel (II) Catalyzed Hydroxamic Acid Formulation Munson, I., Papadimitriou, D., DeLuca, P.P., J. Pharm. Sci., 68(10), 1333-35 (1979). Determining Osmolarities: A Practical Approach for Multicomponent Intravenous and Parenteral Nutrient Solutions, Gatlin, L., Kulkarni, P., Hussain, A., DeLuca, P.P., Am. J. Hosp. Pharm., 36, 1357-61 (1979). Sepsis in Rabbits Following Administration of Contaminated Infusions Through Filters of Venous Pore Size, Rapp, R.P., Bivins, B.A., DeLuca, P.P., Am. J. Hosp. Pharm., 36, 1711 (1979). Identification of Subvisible Barium Sulfate Crystals in Parenteral Solutions, Bodappati, S., Butler, L.D., Im, S., DeLuca, P.P., J. Pharm. Sci., 69(5), 608-10 (1980). Theoretical Aspects of Particulate Matter Monitoring by Microscopic and Instrumental Methods, Schroeder, H.G., and DeLuca, P.P., J. Parenter Drug Assoc., 34(3), 183-91 (1980).
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Improving Drug Distribution in Solid Oral Dosage Forms Through Application of the Freeze Drying Process, DeLuca, P.P., Machado, H., Schroeder, H.G., APGI Proceedings 2nd International Conference on Pharmaceutical Technology Vol. 1, 45, France, June (1980). The Fate and Effects of 141Ce Labeled Microspheres Following I.V. or I.A. Administration in Beagle Dogs, DeLuca, P.P., Kanke, M., Bivins, B., Slack, J., Simmons, G., Yokel, R., Schroeder, H., Sniecinski, I., APGI Proceedings 2nd International Conference on Pharmaceutical Technology Vol. II, 27, France, June (1980). Crystallization and Crystalline Kinetics of Frozen Antibiotic Solutions, Gatlin, L., and DeLuca, P.P., APGI Proceedings 2nd International Conference on Pharmaceutical Technology Vol II, 140, France, June (1980). The In-line Filter: A Means of Reducing the Complications of Intravenous Therapy, DeLuca, P.P., Rapp, R.P., Bivins, B.A., APGI Proceedings, 2nd International Conference on Pharmaceutical Technology Vol IV, 181, France, June (1980). Theoretical Aspects of Sterile Filtration and Integrity Testing, Schroeder, H.G. and DeLuca, P.P., APGI Proceedings 2nd International Conference on Pharmaceutical Technology Vol IV, 191, France, June (1980). The Identification of Particulates in Parenteral Products, DeLuca, P.P., Im, S., Boddapati, S., APGI Proceedings 2nd International Conference on Pharmaceutical Technology Vol IV, 199, France, June (1980). Clearance of Ce-141 Labeled Microspheres from the Blood and Distribution in Specific Organs Following Intravenous and Intraarterial Administration in Beagle Dogs, Kanke, M., Simmons, G.H., Weiss, D.L., Bivins, B.A., DeLuca, P.P., J. Pharm. Sci., 69(7), 755 July (1980). Effect of In-line Filtration on the Potency of Low Dose Drugs, Butler, L.D., Munson, I.M., DeLuca, P.P., Am. J. Hosp. Pharm., 37, 935 (1980). Guidelines for the Identification of Particles in Parenterals, DeLuca, P.P., Boddapati, S., Im, S., FDA Bylines, 10, 111-165 (1980). A Study of Phase Transitions in Frozen Antibiotic Solutions by Differential Scanning Calorimetry, Gatlin, L. and DeLuca, P.P., J. Parenter. Drug Assoc., 34(5), 398-408, (1980). Theoretical Aspects of Sterile Filtration and Integrity Testing, Schroeder, H.G. and DeLuca, P.P., Pharm. Tech., 4(11), 80 (1980). Compatibility of Amphotericin B with Certain Large-volume Parenterals, Jurgens, R.W., DeLuca, P.P., Papadimitriou, P., Am. J. Hosp. Pharm., 38, 377-78 (1981). Acute Hemodynamic Effects and Blood Pool Kinetics of Polystyrene Microspheres Following I.V. Administration, Slack, I.D., Kanke, M., Simmons, G.H., DeLuca, P.P., J. Pharm. Sci., 70(6), 660-64 (1981). Acute Toxicity of Latex Microspheres, Yokel, R., Simmons, G.H., Sabo, I., DeLuca, P.P., Toxicol. Lett., 9, 165-170 (1981). The Application of Proposed Procedures for Testing for Extractables in Plastic Containers, DeLuca, P.P., Papadimitriou, D., DeLuca, P.P., J. Parenter. Sci. Technol., 36(1), 28 (1982).
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Biodegradable Microspheres for Controlled Drug Delivery Via the Parenteral Route, DeLuca, P.P., Sato, T., Schroeder, H.G., Kanke, M., APGI Proceedings 3rd International Conference on Pharmaceutical Technology, Vol IV, p. 152-161, France, (1983). Interaction of Microspheres with Blood Constituents and Effect on Immune Response, Kanke, M., Sniecinski, I., DeLuca, P.P., APGI Proceedings 3rd International Conference on Pharmaceutical Technology, Vol IV, p. 162-169, France (1983). Binding of Select Drugs to Cellulosic Ester Membranes During I.V. Administration and Continuous Ambulatory Peritoneal Dialysis, Kanke, M., Eubanks, I., DeLuca, P.P., APGI Proceedings of 3rd International Conference on Pharmaceutical Technology Vol III, 308-317, France (1983). High-Performance Liquid Chromatographic Methods for Antibiotics Admixed with Intravenous Infusates, Athanikar, N.K., Jurgens, R.W., Sturgeon, R.I., DeLuca, P.P., Papadimitriou, D., J. Parenter. Sci. Technol., 37(4),125-28 (1983). The Binding of Selected Drugs to a "Treated" Inline Filter, Kanke, M., Eubanks, I.L., DeLuca, P.P., Am. J. Hosp. Pharm., 40, 1323-1328 (1983). Interaction of Microspheres with Blood Constituents: I. Uptake of Polystyrene Spheres by Monocytes and Granulocytes and Effect on Immune Responsiveness of Lymphocytes, Kanke, M., Sniecinski, I.I., DeLuca, P.P., J. Parenter. Sci. Technol., 37(6), 210 (1983). Biodegradable Microspheres for Injection and Inhalation, DeLuca, P.P., Kanke, M., Sato, T., in Microspheres and Drug Therapy: Pharmaceutical, Immunological and Medical Aspects, p. 343-44 Elsevier, Amsterdam, (1984). Distribution and Elimination of Coated Polymethyl[2-14C] Methacrylate Nanoparticles after IV Injection in Rats, Leu, D., Manthey, B., Kreuter, I., Speiser, P., DeLuca, P.P., J. Pharm. Sci., 73(10), 1433-37 (1984). Osmolality of Small-Volume Intravenous Admixtures, Wermeling, D.P., Rapp, R.P., DeLuca, P.P., Piecoro, I.I., Am. J. Hosp. Pharm., 42, 1739-44 (1985). Binding of Insulin to Continuous Ambulatory Peritoneal Dialysis Administration System, DeLuca, P.P., Jay, M., Kanke, M., Am. J. Hosp. Pharm., 43, 81-88 (1986). Interaction of Microspheres with Blood Constituents: II Uptake of Biodegradable Particles by Macrophages, Kanke, M., Morlier, E., Geissler, P., Powell, D., Kaplan, A., DeLuca, P.P., J. Parenter. Sci. Technol., 40, 114-118 (1986). An Approach of Setting Particulate Matter Standards for Small Volume Parenterals, DeLuca, P.P., Boddapati, S., Haack, D., Schroeder, H., J. Parenter. Sci. Technol., 40, 2-13 (1986). The Investigation of PVP as a Cryoprotectant in Freeze Drying of Purified Protein Solutions, Townsend, M.W. and DeLuca, P.P., Proceedings of the 2nd International Symposium on Povidone, p. 248, University of Kentucky, Lexington, KY (1987). Porous Biodegradable Microspheres for Parenteral Administration, DeLuca, P. P., Hickey, A.J., Kanke, M., Hazrati, A., Wedlund, P., Rypacek, F., Topics in Pharmaceutical Sci., p. 429, Elsevier Science Publishers, Amsterdam, (1987). An Overview of the Technical Issues in Particle Detection, DeLuca, P.P., Conti, B., Knapp, I., Proceedings of the International Conference on Liquid Borne Particle Inspection and Metrology, p. 376, Parenteral Drug Association, Philadelphia, PA, (1987).
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Porous Biodegradable Microspheres for Controlled Drug Delivery. I. Assessment of Processing Conditions and Solvent Removal Techniques., Sato, T., Schroeder, H.G., Kanke, M., DeLuca, P.P., Pharm. Res., 5, 21 (1988). Review of Commercially Available Particulate Measurement Systems, Part I: Instrumentation, Knapp, I.Z. and DeLuca, P.P., J. Parenter. Sci. Technol., 42(15) Tech. Report #9, S3 (1988). Review of Commercially Available Particulate Measurement Systems, Part II: A Selected Annotated Bibliography on Particulate Matter, DeLuca, P.P., Conti, B., Knapp, J.Z., J. Parenter. Sci. Technol., 42(15), Tech Report #9, 519 (1988). The Effect of Solvent Addition and Thermal Treatment on the Freeze Drying of Cefazolin Sodium. Koyama, Y., Kamat M., DeAngelis, R.I., Srinivasan, R., DeLuca, P.P., J. Parenter. Sci. Technol., 42(2), 47-52 (1988). Hygroscopicity of Cefazolin Sodium: Application to Evaluate Crystallinity of Freeze Dried Product, Osawa, T., Kamat, M., DeLuca, P.P., Pharm. Res., 5 (7), 421-425 (1988). Estimation of the Degree of Crystallinity of Cefazolin Sodium by X-ray and Infrared Methods, Kamat, M., Osawa, T., DeAngelis, R.I., Koyama, Y., DeLuca, P.P., Pharm., Res., 5(7), 426-429 (1988). Interaction of Microspheres with Blood Constituents III. Macrophage Phagocytosis of Various Types of Polymeric Drug Carriers, Kanke, M., Geissler, R.G., Powell, D., Kaplan, A., DeLuca, P.P., J. Parenter. Sci. Technol., 42(5), 157-165 (1988). The Use of Lyoprotectants in the Freeze Drying of a Model Protein, Ribonuclease A, Townsend, M.W. and DeLuca, P.P., J. Parenter. Sci. Technol., 42(6), 190-199 (1988). Cleanliness Assessment of Supplier-Cleaned Rubber Closures, Townsend, M.W., Conti, B., DeLuca, P.P., J. Parenter. Sci. Technol., 43(2), 98-102 (1989). Tissue Distribution of Indium-111 Labeled Poly (Glycolic Acid) Matrices Following Jugular and Hepatic Portal Vein Administration, Hazrati, A.M., Akrawi, S., Hickey, A.J., Wedlund, P., DeLuca, P.P., J. Control Release, 9(3), 205-214 (1989). Prednisodone-2l-Acetate Polyglycolic Acid Microspheres: Influence of Matrix Characteristics on Release, Redmon, M.P., Hickey, A.I., DeLuca, P.P., J. Control. Release, 9 (3), 205-214 (1989). Near-Infrared Spectroscopic Determination of Residual Moisture in Lyophilized Sucrose Through Intact Glass Vials, Kamat, M.S., Lodder, R.A., DeLuca, P.P., Pharm. Res., 6 (1l), 961-965 (1989). Acceleration of Freeze-Drying Cycles of Aqueous Solutions of Lactose and Sucrose with Tertiary Butyl Alcohol, DeLuca, P.P., Kamat, M.S., Koida, Y., Y Congr. Int. Technol. Pharm., 5th, 1, 439-447 (1989). The Effects of Formulation Additives on the Degradation of Freeze Dried Ribonuclease A, Townsend, M.W., Byron, P.R., DeLuca, P.P., Pharm. Res., 7(10), 1086-1091 (1990). Stability of Ribonuclease A in Solution and the Freeze Dried State, Townsend, M.W. and DeLuca, P.P., J. Pharm. Sci., 79 (12), 1083-1086 (1990). Lipid and Polimeric Microspheres as Novel Drug Delivery Systems, DeLuca, P.P., Inflamacion 93(2), 151-152 (1990).
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Oxidative Degradation of a Freeze-Dried Model Protein, Townsend, M.W. and DeLuca, P.P., Proc. of the Pharm. Tech. Conf., Sept. 1990, New Brunswick, N.J., Aster Publ. Co., Eugene, Oregon. In-Vivo Assessment of Salmon Calcitonin Sustained Release From Biodegradable Microspheres, Lee, K.C., Mehta, R., Soltis, E., DeLuca, P.P., J. Control. Release., 17, 199-206 (1991) Nature of Aggregates Formed During Storage of Freeze Dried Ribonuclease A, Townsend, M.W. and DeLuca, P.P., J. Pharm. Sci., 80 (1), 63-66 (1991). Simultaneous Determination of Prostaglandin E, A, and B, by Reversed-Phase High Performance Liquid Chromatography for the Kinetic Studies of PGE in Solution, Lee, K.C. and DeLuca, P.P., J. Chromatogr, 555, 73-80 (1991). Skeletal Effects of Calcitonin in Ovariectomized Rats, Wronski, T.J., Yen, C.F., Burton, K.W., Mehta, R.C., Newman, P.S., Soltis, E.E., DeLuca P.P., Endocrinology, 129 (4), 2246-2250 (1991). In Vivo Evaluation of Biodegradable Progesterone Microspheres In Mares, Gupta, P.K., Mehta, R.C., Douglas, R.H., DeLuca, P.P., Pharm. Res., 9, 1502-1506 (1992). Fat Emulsion Particle-Size Distribution in Total Nutrient Admixtures, Mehta, R.C., Head, L.F., Hazrati, A.M., Parr, M., Rapp, R.P., DeLuca, P.P., Am. J. Hosp. Pharm., 49, 2749-2754 (1992). Degradation of Synthetic Salmon Calcitonin in Aqueous Solution, Lee, K.C., Lee, Y.I., Song, H.M., Chun, C.I., DeLuca, P.P., Pharm. Res., 9, 1521-1523 (1992). Sustained Bronchodilation with Isoproterenol Poly (Glycolic-co-lactide) Microspheres, Lai, Y., Mehta, R.C., Thacker, A., Yoo, S.D., McNamara, P.J., DeLuca, P.P., Pharm. Res., 10, 119-125 (1993). Present and Future Status of Biotechnology Derived Pharmaceuticals, DeLuca, P.P., in Recent Advances in Pharmaceutical and Industrial Biotechnology, 6th International Pharmaceutical Technology Symposium, Hacettepe University, Ankara, Turkey. September 1992. Published Editions de Sante, Paris, in the series "Minutes", 209-223 March (1993). Biodegradable Polyesters for Drug and Polypeptide Delivery, DeLuca, P.P., Mehta, R., Hausberger, A.G., Thanoo, B.C., in Polymeric Delivery Systems Properties and Applications, ACS Symposium Series 520, Chapter 4, 53-79 (1993). Formulation Strategies for Proteins and Peptides, DeLuca, P.P., J. Korean Pharm. Sci., 23(3), S51 (1993). Biodegradable Microspheres as Depot System for Parenteral Delivery of Peptide Drugs, Mehta, R.C., Ramasubu, J., Calis, S., Thanoo, B.C., Burton, K.W., DeLuca, P.P., J. Control Release, 29, 375-384 (1994). Reversed-phase High Performance Liquid Chromatography for Simultaneous Determination of E2, A2 and B2 Prostaglandins, Lee, K.C., Song, H.M., Oh, I.J., DeLuca, P.P., Int. J. Pharm., 106, 167-171 (1994). Parenteral Products: Design and Optimization, Including Freeze Drying, DeLuca, P., International Pharm. Journ., 7, S14 (1993). Topics in Pharmaceutical Sciences , Pharm. Sci. of F.I.P., Congress Proceedings, Medpharm Publishers, Chap. 32, pg.471 (1994). Adsorption of Salmon Calcitonin to PLGA Microspheres, Calis, S., Ramasubu, J., Tsai, T., Mehta, R.C., DeLuca, P.P., Pharm Res, 12 (7), 1072-1076 (1995).
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Biodegradable Indium-111 Labeled Microspheres for In-Vivo Evaluation of Distribution and Elimination, Thanoo, B.C., Doll, W., Mehta, R.C., Digenis, G.A., DeLuca, P.P., Pharm Res, 12 (12), 2060-2064 (1995). Post-column Fluorescence HPLC for Salmon Calcitonin Formulations, Lee, K.C., Yoon, J.Y., Woo, B.H., DeLuca, P.P., Int. J. Pharm, 114, 215-220 (1995). Characterization of Biodegradable Poly (D,L-lactide-Co-Glycolide) Polymers and Microspheres, Hausberger, A.G., DeLuca, P.P., J. Pharm. Biomed. Anal., 13 (6), 747-760 (1995). Thermal Analysis of Tertiary Butyl Alcohol-Water System and its Implications on Freeze-Drying, Kasraian, K. and DeLuca, P.P., Pharm. Res., 12 (4), 484-490 (1995). The Effect of Tertiary Butyl Alcohol (TBA) on the Resistance of the Dry Product Layer During Primary Drying, Kasraian, K. and DeLuca, P.P., Pharm. Res., 12 (4), 491-495 (1995). Gamma Irradiation Effects on Molecular Weight and In Vitro Degradation of Poly (D,L-lactide-coglycolide) Microparticles, Hausberger, A.G., Kenley, R.A., DeLuca, P.P., Pharm. Res., 12 (6), 851856 (1995). Reversed-phase High Performance of Salmon Calcitonin and its Degradation Products in Biological Samples Using Column Switching and Flow-through Radioisotope Detection, Lee, H.S., Lee, J.S., Lee, H-Y., Jung, Y.S., Lee, K.C., DeLuca, P.P., J. Chromatogr. B: Biomed. Appl., 673, 136-141 (1995). Prediction of Solvent Removal Profile and Effect on Properties for Peptide-Loaded PGLA Microspheres Prepared by Solvent Extraction/Evaporation Method, Li, W.I., Anderson, K.W., DeLuca, P.P., J. Control. Release, 37 (3), 199-214 (1995). Kinetic and Thermodynamic Modeling of the Formation of Polymeric Microspheres Using Solvent Extraction/Evaporation Method, Li, W.I., Anderson, K.W., DeLuca, P.P., J. Control. Release, 37 (3), 187-198 (1995). Adsorption of Peptides to Poly (d,l-lactide-co-glycolide): 1. Effect of physical factors on the adsorption. Tsai, T., Mehta, R.C., DeLuca, P.P., Int. J. Pharm., 127, 31-42 (1996). Adsorption of Peptides to Poly (d,l-lactide-co-glycolide): 2. Effect of solution properties on the adsorption. Tsai, T., Mehta, R.C., DeLuca, P.P., Int. J. Pharm., 127, 43-52 1996). Effect of Solvent Removal Technique on the Matrix Characteristics of Polylactide/glycolide Microspheres for Peptide Delivery, Jeyanthi, R., Thanoo, B.C., Mehta, R.C., DeLuca, P.P., J. Control. Release, 38 (2-3), 235-244 (1996). Interaction of Recombinant Human Bone Morphogenetic Protein-2 with Poly (d,l lactide-coGlycolide) Microspheres, Duggirala, S., Mehta, R.C., DeLuca, P.P., Pharm. Dev. Tech., 1 (1), 11-19 (1996). Peptide Containing Microspheres from Low Molecular Weight and Hydrophilic Poly (d,l-lactide-coglycolide), Mehta, R.C., Thanoo, B.C., DeLuca, P.P., J. Control. Release, 41 (3), 249-257 (1996). Rheological Characterization of Cellulosic and Alginate Polymers, Duggirala, S. and DeLuca, P.P., J. Pharm. Sci. Tech., 50 (5), 290-296 (1996). Buffer Uptake and Mass Loss Characteristics of Freeze-Dried Cellulosic and Alginate Devices, Duggirala, S. and DeLuca, P.P., J. Pharm. Sci. Tech., 50 (5), 297-305 (1996).
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The Evaluation of Lyophilized Polymer Matrices for Administering Recombinant Human Bone Morphogenetic Protein-2, Duggirala, S.S. and DeLuca, P.P., Pharm. Dev. Technol., 1 (2), 165-175 (1996). A Comparison of the Skeletal Effects of Intermittent and Continuous Administration of Calcitonin in Ovariectomized Rats, Li, M., Shen, Y., Burton, K.W., DeLuca, P.P., Mehta, R.C., Baumann, B.D., Wronski, T.J., Bone, 18 (4), 375-380 (1996). Effects of Processing Parameters on the Properties of Peptide Containing PLGA Microspheres, Jeyanthi, R., Mehta, R.C., Thanoo, B.C., DeLuca, P.P., J. Microencapsul., 14(2), 163-174 (1997). Development of a Statistical Model for the Formation of Poly [Acryloyl Hydroxyethyl Starch] Microspheres, Huang, L., Mehta, R., DeLuca, P.P., Pharm.Res., 14 (4), 469-474 (1997). Evaluation of a Statistical Model for the Formation of Poly [Acryloyl Hydroxyethyl Starch] Microspheres, Huang, L., Mehta, R., DeLuca, P.P., Pharm. Res., 14 (4), 475-482 (1997). Effect of Surface Treatment on the Respirable Fractions of PLGA Microspheres Formulated for Dry Powder Inhalers, Philip, V.A., Mehta, R.C., Mazumder, M.K., DeLuca, P.P., Int.J.Pharm., 151, 165174 (1997). In-Vitro and In-Vivo Respirable Fractions of Isopropanol Treated PLGA Microspheres Using a Dry Powder Inhaler, Philip, V.A., Mehta, R.C., DeLuca, P.P., Int. J. Pharm., 151, 175-182 (1997). Reversed-phase High-Performance Liquid Chromatography of Radioiodinated Salmon Calcitonins, Lee, K.C., Kang, T.S., Woo, B.H., Lee, J.T., Lee, H.S., DeLuca, P.P., J.Chromatogr. B.: Biomed. Appl., 694, 31-37 (1997). Stability of Somatostatin Analogue Cyclic Octapeptide, Octastatin, in Aqueous Solution, Jang, S.W., Woo, B.H., Lee, J.T., Moon, S.C., Lee, K.C., DeLuca, P.P., Pharm. Dev. Technol., 2(4), 409-414 (1997). Electrostatic Charge and Particle Size Distributions Analyses of Poly (D,L-lactide-co-glycolide) Microspheres Formulated for Dry Powdered Aerosols, Philip, V.A., Mehta, R., DeLuca, P., Mazumder, M.K., Particulate Science & Technology, 15(3), 245-261 (1997). In Vitro Cellular Responses to Bioerodible Particles Loaded with Recombinant Human Bone Morphogenetic Protein-2, Puleo, D.A., Huh, W.W., Duggirala, S.S., DeLuca, P.P., J. Biomed. Mater. Res., 41, 104-110 (1998). Two Lyophilized Polymer Matrix Recombinant Human Bone Morphogenetic Protein-2 Carriers in Rabbit Calvarial Defects, Rodgers, J.B., Vasconez, H.C., Wells, M.D., DeLuca, P.P., Faugere, M.C., Fink, B.F., Hamilton, D., J. Craniofac. Surg., 9(2), 147-153 (1998). Effect of Polytyrosine on the Hydrophobicity of Hydroxyethyl Starch Microspheres, Chadha, H.S. and DeLuca, P.P., Pharm. Dev. Tech., 3(4), 597-606 (1998). Characterization and Evaluation of Polymeric Systems for Peptide Delivery, DeLuca, P.P., Burton, K., Perlwitz, A., Shameem, M., Lee, H., 8th International Pharm. Tech. Symposium Minutes, 79-90, Editions De Sante, Paris, (1998). Preparation and Characterization of Polyethylene Glycol Modified Salmon Calcitonins, Lee, K.C., Tak, K.K., Park, M.O., Lee, J.T., Woo, B.H., Yoo, S.D., DeLuca, P.P., Pharm. Dev. Technol., 4(2), 269-275 (1999).
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Preparation and Characterization of Poly (D,L-lactide-co-glycolide) Microspheres for Controlled Release of Poly (L-Lysine) Complexed Plasmid DNA, Capan, Y., Woo, B.H., Gebrekidan, S., Ahmed, S., DeLuca, P.P., Pharm. Res., 16(4), 509-513 (1999). Stability of Poly (L-Lysine) Complexed Plasmid DNA During Mechanical Stress and DNase I Treatment, Capan, Y., Woo, B.H., Gebrekidan, S., Ahmed, S., DeLuca, P.P., Pharm. Dev. Tech.. 4(4), 491-498 (1999). Influence of Formulation Parameters on the Characteristics of Poly (D,L-lactide-co-glycolide) Microspheres Containing Poly (L-lysine) Complexed Plasmid DNA, Capan, Y., Woo, B.H., Gebrekidan, S., Ahmed, S., DeLuca, P.P., J. Control. Release, 60, 279-286 (1999). Effect of -Irradiation on Peptide-Containing Hydrophilic Poly (D,L-lactide-co-glycolide) Microspheres, Shameem, M., Lee, H., Burton, K., DeLuca, P.P., J. Pharm. Sci. Technol., 53(6), 309313 (1999). A Short Term (Accelerated Release) Approach to Evaluate Peptide Release from PLGA DepotFormulations, Shameem, M., Lee, H., DeLuca, P.P., AAPS PharmSci., 1(3) Article 7 (1999). Isolation, Characterization and Stability of Positional Isomers of Mono-PEGylated Salmon Calcitonins, Lee, K.C., Moon, S.C., Park, M.O., Lee, J.T., Na, D.H., Yoo, S.D., Lee, H.S., DeLuca, P.P., Pharm. Res., 16(6), 813-818 (1999). Recombinant Human Bone Morphogenetic Protein-2 Binding and Incorporation in PLGA Microsphere Delivery Systems, Schrier, J.A. and DeLuca, P.P., Pharm. Dev. Technol., 4(4), 611-621 (1999). Determination of Salmon Calcitonin in Formulations by High Performance Liquid Chromatography with Electrochemical Detection, Lee, H.S., Choi, S.J., Lee, H.M., Jeong, C.K., Kim, S.B., Lee, J.T., Yoo, S.D., DeLuca, P.P., Lee, K.C., Chromatographia, 50(11/12), 701-704 (1999). Extended Release Peptide Delivery Systems Through the Use of PLGA Microsphere Combinations, Burton, K.W., Shameem, M., Thanoo, B.C., DeLuca, P.P., J. Biomater. Sci., Polym. Ed., 11(7), 715729 (2000). Enhancing Initial Release of Peptide from PLGA Microspheres by Addition of a Porosigen and Increasing Drug Load, Ravivarapu, H.B., Lee, H., DeLuca, P.P., Pharm. Dev. Technol., 5(2), 281-290 (2000). Polymer and Microsphere Blending to Alter the Release of a Peptide from PLGA Microspheres, Ravivarapu, H.B., Burton, K., Shameem, M., DeLuca, P.P., Eur. J. Pharm., 50, 263-270 (2000). Effect of the Concurrent LHRH Antagonist Administration with a LHRH Superagonist in Rats, Kostanski, J.W., Dani, B.A., Schrier, B., DeLuca, P.P., Pharm. Res., 17(4), 445-450 (2000). A Novel in Vitro Release Technique for Peptide Containing Biodegradable Microspheres, Kostanski, J.W. and DeLuca, P.P., AAPS PharmSciTech, 1(1), Article 4 (2000). Preparation, Characterization and In Vitro Evaluation of 1- and 4- Month Controlled Release Orntide PLA and PLGA Microspheres, Kostanski, J.W., Thanoo, B.C., DeLuca, P.P., Pharm. Dev. Tech., 5(4), 585-596 (2000). Evaluation of Orntide Microspheres in a Rat Animal Model and Correlation to In Vitro Release Profiles, Kostanski, J.W., Dani, B.A., Reynolds, G.A., Bowers, C.Y., DeLuca, P.P., AAPS PharmSciTech, 1(4), Article 27 (2000).
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Formulation and In Vitro Transfection Efficiency of Poly (D,L-lactide-co-glycolide) Microspheres Containing Plasmid DNA for Gene Delivery, Gebrekidan, S., Woo, B.H., DeLuca, P.P., AAPS PharmSciTech, 1(4), Article 28 (2000). Pharmacokinetic Disposition of Polyethylene Glycol-Modified Salmon Calcitonins in Rats, Yoo, S.D., Jon, H., Shin, B.S., Lee, H.S., Park, M.O., DeLuca, P.P., Lee, K.C., Chem. Pharm. Bull. (Toyko), 48(12), 1921-1924 (2000) Novel Delivery Systems for Peptides and Gene Therapy, DeLuca, P.P., Capan, Y., Woo, B.H., Kostanksi, J., Gebrekidan, S., Dani, B., 10th International Pharm Tech Symposium, Minutes, Editions De Sante, Paris (2001). Return to Fertility After Extended Chemical Castration with a GNRH Antagonist, Kostanski, J.W., Jiang, G., Dani, B.A., Murty, S.B., Schrier, B., Thanoo, B.C., DeLuca, P.P., BioMed Central, BMC Cancer, 1:18 (2001). Use of PharmaSep Unit for Processing Microspheres, Jo, Y.W., Woo, B.H., Hazrati, A.M., DeLuca, P.P., AAPS PharmSciTech, 2(1), Tech Note 2 (2001). Preparation, Characterization and In Vivo Evaluation of 120-Day Poly (D,L-lactide) Leuprolide Microspheres, Woo, B.H., Kostanski, J.W., Gebrekidan, S., Dani, B.A., Thanoo, B.C., DeLuca, P.P., J.Control. Release, 75, 307-315 (2001). Preparation and Characterization of a Composite PLGA and Poly (Acryloyl Hydroxyethyl Starch) Microsphere System for Protein Delivery, Woo, B.H., Jiang, G., Jo, Y.W., DeLuca, P.P., Pharm. Res., 18(11), 1600-1606 (2001). Porous Bone Morphogenetic Protein-2 Microspheres: Polymer Binding and In Vitro Release, Schrier, J.A. and DeLuca, P.P., AAPS PharmSciTech, 2(3), No. 17 (2001). Effect of Freeze Dried CMC/PLGA Microsphere matrix of BMP2 on Bone Healing, Schrier, J.A., Fink, B.F., Rodgers, J.B., Vasconez, H.C., DeLuca, P.P., AAPS PharmSciTech, 2(3), No. 18 (2001). Enhancement of Bone Growth by Sustained Delivery of Recombinant Human Bone Morphogenetic Protein-2 in a Polymeric Matrix, Woo, B.H., Fink, B.F., Page, R., Schrier, J.A., Jo, Y.W., Jiang, G., DeLuca, M., Vasconez, H.C., DeLuca, P.P., Pharm. Res., 18(12), 1747-1753 (2001). Freeze-Drying of Microparticulates in a Vibro-Separator, Na, D.H., Woo, B.H., Jo, Y.W., Hazrati, A.M., DeLuca, P.P., AAPS PharmSciTech, 2(2) Tech Note 3 (2001). Skeletal Effects of Parathyroid Hormone (1-34) During Early Estrogen Deficiency Stage in Ovariectomized Rats With or Without Concurrent Administration of Salmon Calcitonin, Dani, B.A. and DeLuca, P.P., AAPS PharmSci, 3(4), No. 27 (2001). Preparation, Characterization and In Vivo Evaluation of Salmon Calcitonin Microspheres, Dani, B.A. and DeLuca, P.P., AAPS PharmSciTech, 2(4), No. 19 (2001). In Vitro Characterization and In Vivo Testosterone Suppression of 6-month Release Poly (D,Llactide) Leuprolide Microspheres, Woo, B.H., Na, K.H., Dani, B.A., Jiang, G., Thanoo, B.C., DeLuca, P.P., Pharm. Res., 19(4), 545-549 (2002). Identification and Determination of GnRH Antagonist Gelling at Injection Site, Jiang, G., Gavini, E., Dani, B.A., Murty, S.B., Schrier, B., Thanoo, B.C., DeLuca, P.P., Int. J. Pharm., 233(2), 19-27 (2002).
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Assessment of Protein Release Kinetics, Stability and Protein Polymer Interaction of Lysozyme Encapsulated Poly (D,L-Lactide-Co-Glycolide) Microspheres, Jiang, G., Woo, B.H., Kang, F., Singh, J., DeLuca, P.P., J. Control. Release, 79, 137-154 (2002). Lysozyme Stability in Primary Emulsion for PLGA Microsphere Preparation: Effect of Recovery Methods and Stabilizing Excipients, Kang, F., Jiang, G., Hinderliter, A., DeLuca, P.P., Singh, J., Pharm. Res., 19(5), 629-633 (2002). Effect of Osmotic Pressure in the Solvent Extraction Phase on BSA Release Profile from PLGA Microspheres, Jiang, G., Thanoo, B.C., DeLuca, P.P., Pharm. Dev. Technol., 7(4), 391-399 (2002). A Study of the Anti-resorptive Activity of Salmon Calcitonin Microspheres using Cultured Osteoclastic Cells, Dani, B.A., Raiche, A.T., Puleo, D.A., DeLuca, P.P., AAPS PharmSciTech, 3 (3), No. 21 (2002). Preparation and In Vitro/In Vivo Evaluation of Insulin-loaded Poly (Acryloyl-Hydroxyethyl Starch)PLGA Composite Microspheres, Jiang, G., Qiu, W., DeLuca, P.P., Pharm. Res., 20(3), 452-459 (2003). Preparation and Characterization of Poly (D,L-lactide-co-glycolide) Microspheres for Controlled Release of Human Growth Hormone, Capan, Y., Jiang, G., Giovagnoli, S., DeLuca, P.P., AAPS PharmSciTech, 4(2), No. 28, 236-245 (2003). Monitoring of Peptide Acylation Inside Degrading PLGA Microspheres by Capillary Electrophoresis and MALDI-TOF Mass Spectrometry, Na, D.H., Lee, S.D., DeLuca, P.P., Lee, K.C., J. Control. Release, 92, 291-299 (2003). Identification of Chemically Modified Peptide from PLGA Microspheres under In Vitro Release Conditions, Murty, S.B., Goodman, J., Thanoo, B.C., DeLuca, P.P., AAPS PharmSciTech, 4(4), No. 50 (2003). Preparation and Stability of Poly(Ethylene Glycol) (PEG)ylated Octreotide for Application to Microsphere Delivery, Na, D.H., Murty, S.B., Lee, K.C., Thanoo, B.C., DeLuca, P.P., AAPS PharmSciTech, 4(4), No. 72 (2003). Intranasal Delivery of PEGylated Salmon Calcitonins: Hypocalcemic Effects in Rats, Lee, K.C., Park, M.O., Na, D.H., Youn, Y.S., Lee, S.D., Yoo, S.D., Lee, H.S., DeLuca, P.P., Calcif. Tissue Int., 73, 545-549 (2003). Stability of PEGylated Salmon Calcitonin in Nasal Mucosa, Na, D.H., Youn, Y.S., Park, E.J., Moon, B.W., Cho, O.R., Lee, K.R., Lee, S.D., Yoo, S.D., DeLuca, P.P., Lee, K.C., J. Pharm. Sci., 93(2), 256-261 (2004). Assessment of Fertility in Male Rats After Extended Chemical Castration with a GnRH Antagonist, D'Souza, S.S., Selmin, F., Murty, S.B., Qiu, W., Thanoo, B.C., DeLuca, P.P., AAPS PharmSci, 6(1), No. 10 (2004). Direct Determination of the Peptide Content in Microspheres by Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry, Na, D.H., DeLuca, P.P., Lee, K.C., Anal. Chem., 76(9), 2669-2673 (2004). In Vitro Cytotoxicity of Mitoxantrone-Incorporated Albumin Microspheres on Acute Promyelocytic Leukemia Cells, Bozdag, S., Capan, Y., Vural, I., Dalkara, T., Dogan, A.L., Guc, D., Hincal, A.A., DeLuca, P.P., J. Microencapsul., 21(7), 751-760 (2004)
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In Vivo Release Kinetics of Octreotide Acetate from Experimental Polymeric Microsphere Formulations using O/W and O/O Processes, Murty, S.B., Wei, Q., Thanoo, B.C., DeLuca, P.P., AAPS PharmSciTech, 5(3), No. 49 (2004). Impurity Formulation Studies with Peptide-Loaded Polymeric Microspheres I: In Vivo Evaluation, Murty, S.B., Thanoo, B.C., Wei, Q., DeLuca, P.P., Int. J. Pharm., 297, 50-61 (2005). Impurity Formulation Studies with Peptide-Loaded Polymeric Microspheres II: In Vitro Evaluation, Murty, S.B., Na, D.H., Thanoo, B.C., DeLuca, P.P., Int. J. Pharm., 297, 62-72 (2005). PEGylation of Octreotide: I. Separation of Positional Isomers and Stability Against Acylation by Poly (D,L-lactide-co-glycolide), Na, D.H. and DeLuca, P.P., Pharm. Res., 22(5), 736-742 (2005). PEGylation of Octreotide II: Effect of N-Terminal Mono-PEGylation on Biological Activity and Pharmacokinetics, Na, D.H., Lee, K.C., DeLuca, P.P., Pharm. Res., 22(5), 743-749 (2005). Chewing Gum of Antimicrobial Decapeptide (KSL) as a Sustained Antiplaque Agent: Preformulation Study, Na, D.H., Faraj, J., Capan, Y., Leung, K.P., DeLuca, P.P., J. Control. Release 107, 122-130 (2005). Formulation and In Vitro Bioactivity of Mitoxantrone-loaded Biodegradable Microspheres on Rat Glioma (RG2) Cells, Bozdag, S., Capan, Y., Vural, I., Dalkara, T., Dogan, A.L., Guc, D., Hincal, A.A., DeLuca, P.P., J. Drug Del. Sci. Tech., 15(3), 201-206 (2005). Plasticizing Effect of Water on Poly (Lactide-co-glycolide), Blasi, P., D'Souza, S.S., Selmin, F., DeLuca, P.P., J. Control. Release , 108, 1-9 (2005). Development of a Dialysis in Vitro Release Method for Biodegradable Microspheres, D'Souza, S.S. and DeLuca, P.P., AAPS PharmSciTech 6(2) No. 42 (2005). A Model-dependent Approach to Correlate Accelerated with Real-time Release from Biodegradable Microspheres, D'Souza, S. S., Faraj, J. A., DeLuca, P. P., AAPS PharmSciTech, 6(4), No. 70 (2005). Methods to Assess in Vitro Drug Release from Injectable Polymeric Particulate Systems, D'Souza, S. S. and DeLuca, P.P., Pharm. Res. 23(3), 460-474 (2006). An interview with Professor Patrick DeLuca and Dr. Susan D'Souza on a novel In Vitro Technique, DeLuca, P. P., D'Souza, S., Dissolution Technologies, 21-23, May 2006 Unstirred Water Layer Effects on Peptide Release from Biodegradable Microspheres, D'Souza, S. S., Faraj, J., DeLuca, P. P., in revision, J. Control. Release. Accelerated in Vitro Release as a Quality Control Tool for Biodegradable Microspheres, D'Souza, S. S., Faraj, J., Dorati, R., DeLuca, P., in revision, J. Control Release. Biodegradable Microspheres: Acceleration of Poly (D, L-Lactide-Co-Glycolide) Degradation in Presence of Risperidone, Selmin, F., Blasi, P., DeLuca, P.P., submitted to Pharm Res. Stability of Antimicrobial Decapeptide (KSL) and its Analogues for Delivery in the Oral Cavity, Na, D.H., Faraj, J., Yilmaz, C., Leung, K.P., and DeLuca, P.P., Pharm Res. 24, (2007) in press The Development of a Peptide-Containing Chewing Gum as a Sustained Release AntiplaqueAntimicrobial Delivery System, Faraj, J., Dorate, R., Schoubben, A., Worthen, D., Selmin, F., Capan, Y., Leung, K.P., DeLuca, P.P., AAPS PharmSciTech, 8 (2007) in press
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Acceleration of Poly (D,L-Lactide-G-Glycolide) Degradation in the Presence of Risperidone, Selmin, F, Blasi, P, Faraj, J.A., D'Souza, S.S., Dorati, R, DeLuca, P.P., submitted to Pharm Res. Approaches to Model IVIVC from Microspheres Dosage Forms, in preparation.

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U.S. Patent 3,429,967; February 25, 1969, Stable Neomycin solution. U.S. Patent 4,267,449; May l2, 1981, Testing the Integrity of Liquid Containing Hermetically Sealed Containers by the Use of Radioactive Markers. (with L.D. Butler). U.S. Patent 4,741,872; May 3, 1988, European #0245820A2, Australian #600723, Canadian #1,309,657; November 3, 1992, Preparation of Biodegradable Microspheres as a Carrier for Macromolecules (with Frantisek Rypacek). U.S. Patent 4,818,542; April 4, 1989, European #0391893, October 17, 1990; Canadian #1,308,356, October 6, 1992; European #0391893B1, August 25, 1993; Australian #647890, August 29, 1994; Porous Microspheres for Drug Delivery and Methods for Making Same. U.S. Patent 5,160,745; November 3, 1992, Biodegradable Microspheres as a Carrier for Macromolecules (with Frantisek Rypacek). Canadian Patent 2,046,830; February 26, 1999, Finnish Patent No. 104954; May 15, 2000, U.S. Patent 6,306,406; October 23, 2001, Mexican Patent 9,100,249; June 21, 2002, Drug Delivery System Involving Interaction Between Protein or Polypeptide and Hydrophobic Biodegradable Polymer.

4.

5. 6.

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A.

Administrative Experience 1. Academia: 1.1 Principle administrative responsibilities of Associate Dean and Division Director: (a) (b) (c) (d) (e) (f) Prepared fiscal and biennium budgets for the College and Divisions within the College. Oversight of institutional grant requests. Prepared the 5-year plan (alternate years). Evaluated and recommended space allocations, renovations and utilization. Modified and improved systems, procedures and services As a Division Director, assessed the needs of the division and prepared budget developed good morale and good standards of performance among division personnel and evaluated division personnel on a regular basis and attempted to promote. Served on special assignments from the Chancellor for the Medical Center. Coordinated planning for clinical aspects of pharmacy in the Medical Center. Coordinated planning and occupancy of new College of Pharmacy Building. Served as an Interim Director of Center for Pharmaceutical Science and Technology. Co chaired committee for Reorganization of Pharmaceutical Sciences Faculty. Served as Interim Chair of Pharmaceutical Sciences Faculty.

(g) (h) (i) (j) (k) (l) 1.2

Research Program: (a) (b) Direct research staff of post-doctoral fellows, graduate students and research technicians. Manage annual budget of ~ $500,000 and 3-5 funded projects.

2. Industry: At CIBA as a Senior Research Pharmacist was in charge of Stability Evaluation Programs. Also was liaison with the Animal Health Group. As manager of Special Projects was responsible for locating a plant site and establishing the manufacturing operation for Prefilled Disposable Syringe System. As plant manager had responsibility for a 100 people operation. B. Instructional Experience 1. University of Kentucky: (a) Developed three courses: 1972 - introduced a 4 credit course in Industrial Pharmaceutical Technology; 1973 - introduced a 3 credit course in Sterile Parenterals and Devices; 1974 -as a result of a VA sponsored grant, a 3 credit Pharmaceutical Technology Clerkship course was introduced (changed to 4 credits in 1977; in 1979, essential elements were introduced into core curriculum). Has had major responsibility and shared lectures for Pharmaceutics courses, had shared course responsibility in Pharmaceutical Analysis and Physical Pharmacy and has given lectures in Pharmacotherapeutics, Pharmacy and the Health Care System, and Drugs, Medicines and Society courses.
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(b)

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2.

Off-Campus Teaching (a) Frequent invited speaker at national and international professional and scientific meetings. In the past 35 years personally delivered over 250 seminars (Listing available on request) Developed and directed two intensive short courses; one in sterile products technology and the other in particulate matter monitoring which are presented yearly in New Jersey by the Center for Professional Advancement. (Also presented in Europe, Puerto Rico and to the FDA).

(b)

C.

Professional and Public Service 1. University Committee Activities (C Current) -Chairman of an ad hoc University Task Group on University Goals -University Senate (3 terms) (c) -General Studies Committee -Ad hoc committee on Tobacco and Health Research Institute Policy -Criteria for Promotion and Tenure -University Academic Area Advisory Committee for the Clinical Sciences (2 terms, was chairman for one year) -University Academic Area Advisory Committee for the Biological Sciences for 4 terms; Chairman, 1988-89; Chairman 2002-2005. -Tobacco & Health Institute Policy -Search Committee for Director of Tobacco and Health Research Institute -Chairman of Search Committee for Academic Ombudsman -University Self Study (Physical Resources) -University Major Research Equipment Committee -University Research Committee -Medical Center Space Survey -Medical Center Facilities Advisory Committee -Health Care Delivery Planning Task Force -Steering Committee for Medical Center Planning -Academic Performance, College of Allied Health -New College of Pharmacy Fund Raising Committee -25th Anniversary of Medical Center Planning Committee -Center of Excellence Task Force for Pharmaceutical Science & Technology -Self Study Research Task Group for the College of Medicine -Task force on Equipment Maintenance -Advanced Science and Technology Commercialization Center -Senate Advisory Hearing Committee -Senate Advisory Faculty Code Committee -University Intellectual Properties Committee -Biomedical Engineering Review -Examining Committee for several non Pharmacy Candidates for the degree of Doctor of Philosophy -University Senate Rules Committee (c) -University Self Learning Initiatives Committee (c)

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2.

College Committee Activities -Tripartite Committee -Administrative Council -Graduate Program -Seminar Committee -Ad Hoc Committee on Departmental Reorganization -Building, Space and Services -Appointment, Promotion and Tenure, Chairman -Health and Drug Education -Honors Day -Manpower Study (Chairman) -Self Study Task Group -New Building Planning Committee (Chairman) -Pharm.D. Council -Curriculum -Dedication of New Building Planning Committee -SAKPHA Advisor (1980-81) -Admissions -Deans and Division Directors -Pharm.D. Curriculum Task Force -Chairperson, Search Committee for Medicinal Chemistry & Pharmaceutics Division Chair -AAPS Student Chapter Advisor -First Year Course Coordinator for New Curriculum -Reorganization Task Group Co-Chair -College of Pharmacy Outreach Committee

3.

Other Professional Service (a) Involvement on State Level: Served on an ad hoc study group on pharmacy, appointed by the Council on Public Higher Education, to assist in the development of a comprehensive health sciences education plan for the Commonwealth of Kentucky. Served on a Kentucky Department of Health, Education and Welfare Laetril Committee. Has been a delegate at the Kentucky Pharmacists Association House of Delegates Meetings. Professional Involvement on a National Level: Served as President of the Academy of Pharmaceutical Sciences in 1979-80; Executive Committee member of the Academy for 6 years, 1974-77, 1979-81; an Academy fellow; served on and chaired numerous Academy committees. Charter Member of the American Association of Pharmaceutical Scientists. Member and Chairman (1987) of Board of Director of AAPS. Member of the AAPS Pharmaceutical Technologies Section Executive Committee. Currently, serving as an elected member at large on the AAPS Executive Committee. American Society of Hospital Pharmacists Foundation: Served on Research Awards Committee, 1984 - 1986. American Council on Pharmaceutical Education: Served as a member on accreditation teams. Served on a national group commissioned by the Department of Education to recommend a mechanism to establish a National Commission on Excellence in
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(b)

(c) (d) (e)

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Science and Math Education. (f) Delegate to the U.S.P. Has served on various committees and advisory panels of the U.S.P. Also served on a FDA-USP national coordinating committee to study the problems involved with large volume parenteral solutions. National Cancer Institute: Member of Special Task Force to Review Program and Future Direction of the Pharmaceutical Resources Branch. Editor-in-Chief for International Journal, Pharmaceutical Development and Technology, 1995 ­ 1999. Member of Editorial or Scientific Advisory Board of Pharmaceutical Technology, Journal of Pharmaceutical Sciences and Technology, STP Technology Pharm. Sciences and Microspheres, Microcapsules and Liposomes. Editor-in-chief for AAPS online journal PharmSciTech. 2000Served on NIH, NIDA & SBIR Review Groups, and the FDA Pharmaceutical Sciences Advisory Committee

(g) (h) (i)

(j) (k) 4.

Public Service (a) (b) Served on and chaired parish councils at Newman Center and Christ the King Cathedral Co-Founder of Faith Pharmacy, a Faith-based initiative that provides prescription medications to the indigent population of Central Kentucky. Currently serves as Chair of the Board of Advisors. Served on State Task Force Group to select U.S. Magistrate Judges for 2 districts in Kentucky

(c)

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D.

Research and Scholarship

Research has been directed toward the advancement of pharmaceutical technology in industry and the clinical setting. Has engaged in collaborative, interdisciplinary research associated with the preparation, administration and control of intravenously administered fluids. Current major interests are in developing and evaluating micro-particulate systems to target drugs and agents to specific organs and cells via parenteral and inhalation administration, formulation development of protein molecules and optimization of the freeze-drying process. Research activities have included: (a) assessing the clinical hazards of particulate contamination; (b) determining where particles localize in the body; (c) identifying residues isolated from various injectable preparations and establishing guidelines for identification; (d) evaluating potential solubilizing agents for poorly soluble drugs; (e) studying factors which influence the release of drugs from sustained