Revised 212312015
`
`CURRICULUM VITAE
`
`PATRICK P. DELUCA, Ph.D, RPh, Honn Doct
`3292 Nantucket Drive, Lexington, Kentucky 40502
`859/277-9477(Home) 859-/967-3776(Cell)
`Email: ppdelul@uky.edu
`
`PRESENT POSITION:
`
`Professor Emeritus, Faculty ofPhannaceutical Sciences, University of Kentucky
`College ofPhannacy, 789 S.Limestone Street, Room 385, Lexington, KY 40536-0082
`
`PERSONAL DATA:
`
`Birth date - September 7, 193 5, Scranton, P A
`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
`
`1975-2012
`
`1987- 1988
`
`1978- 1987
`
`1972- 1984
`
`1971 - 1978
`
`1970- 1975
`
`Interim Chair, Faculty ofPham1aceut'ical Sciences
`
`Professor
`
`Acting Director, Center for Pharmaceutical Science and Technology
`
`Associate Dean
`
`Division Director Pharmaceutical Technology Div. 1972-75, Drug lnfonnation &
`Technology 76-81, Drug Information, Evaluation & Technology 81-83,
`Clinical Practice 83-84.
`
`Assistant Dean
`
`Associate Professor
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1041
`
`

`
`Revised 2/2312015
`
`CURRICULUM VITAE
`
`PATRICK P. DELUCA, Pb.D, RPb, Honn Doct
`3292 Nantucket Drive, Lexington, Kentucky 40502
`859/277 -9477(Home) 859-/967 -3776(Cell)
`Email: ppdelul@uky.edu
`
`PRESENT POSITION:
`
`Professor Emeritus, Faculty of Pharmaceutical Sciences, University ofKentucky
`College ofPhannacy, 789 S.Limestone Street, Room 385, 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
`"Photobinding and Photoreactivity of Riboflavin in the Presence
`Dissertation:
`of Macromolecules"
`
`PROFESSIONAL EXPERIENCE:
`
`University of Kentucky College of Pharmacy
`
`1998-2000
`
`1975-2012
`
`1987 - 1988
`
`1978- 1987
`
`1972- 1984
`
`1971 - 1978
`
`1970- 1975
`
`Interim Chair, Faculty ofPham1aceutical Sciences
`
`Professor
`
`Acting Director, Center for Pharmaceutical Science and Technology
`
`Associate Dean
`
`Division Director Pharmaceutical Technology Div. 1972-75, Drug Information &
`Technology 76-81 , Drug Information, Evaluation & Technology 81 -83,
`Clinical Practice 83-84.
`
`Assistant Dean
`
`Associate Professor
`
`Exh. 1041
`
`

`
`Industry
`
`Cormedics Corporation, Somerville, N.J.
`1969 - R 970
`Plant Manager 1969, Director, Development and Control 1970. This was
`a joint venture between CIBA Pharmaceutical Co. and Corning Glass Co
`which developed and manufactured a patented unit dose injectable system.
`
`CIBA Pharmaceutical Co., Summit, N.J.
`1963- 1969
`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 Analytical Chemist, Smith Kline & French Labs, Philadelphia, P A.
`
`Temple University, College of Pharmacy, Philadelphia, PA
`1961- l 962
`Laboratory Instructor (1961 ), Research Associate (1962).
`
`1959- l 961
`
`Relief Pharmacist, Street Road Pharmacy, Cornwell Heights, PA.
`
`1954- 1.957
`
`Pbannacy Technician, Eppley's Pharmacy, Philadelphia, PA
`
`1952- 1954
`
`Pharmacy Technician, Jenkin' s Pharmacy, Scranton, PA.
`
`TEACHING AND RESEARCH INTERESTS:
`
`Pharmaceutical Technology, Sterile Products, Intravenous Administration Systems.
`Controlled Drug Delivery, Target Drug Delivery, Dosage Fonn Development and
`Formulation ofPeptides & Proteins.
`
`ASSOCIATIONS:
`
`American Association ofPharmaceutical Scientists
`American Pharmaceutical Association
`Academy of Pharmaceutical Sciences
`American Association of Colleges ofPharmacy
`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 Phannaceutical Honor Society
`American Society for Parenteral & Enteral Nutrition
`Kentucky Academy of Sciences
`Controlled Release Society
`
`AWARDS RESULTING FROM RESEARCH AND SCHOLASTIC ACIDEVEMENT:
`
`Leo G. Penn Memorial Award- Temple Uruversity 1957
`
`2
`
`Exh. 1041
`
`

`
`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 ofBinding on the Photochemical Properties
`ofHydrocortisone 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 197 5 for the article
`"Filtration and Infusion Phlebitis: A Double-blind Prospective Clinical Study".
`Stimulation ofResearch Awards for 1981 and 1982 from Parenteral Drug Association-
`"Interaction of Micro spheres 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 ofFreezing and Drying on
`Immunoglobulin Conformation".
`Research Achievement Award in Pharmaceutical Technology from the American Association
`ofPharmaceutical Scientists (1988). (First Recipient)
`Certificate ofHonor Award as a Distinguished Alumni ofTemple 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 publlications
`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 ofKentucky (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 ofPharmacy (2003).
`Mentor of visiting scholar (Stefano Giovagnoli) receiving AAPS Graduate Student Award for
`Outstanding Manuscript (2004).
`
`Mentor of graduate student (Susan D'Souza) recipient of AAPS Graduate Student Award for
`Outstanding Manuscript (2005).
`
`3
`
`Exh. 1041
`
`

`
`Honorary Doctorate from University ofPemgia, Italy May 30, 2006.
`
`AAPS Dale Wurster Research Achievement Award in Pharmaceutics (2006)(First Recipient)
`
`Outstanding Manuscript Award in AAPS PharmSciTcch Journal (2006) for publication during 2004 & 2005
`
`AAPS Distinguished Service Award, 2010.
`
`William E. Lyons Award, 2011 for Outstanding Service to the University of Kentucky, the
`community and the Commonwealth of K entucky.
`
`Joseph B Sprowls Distinguished Alumni Award 2012, Temple University School of Pharmacy
`
`PUBLICATIONS:
`
`Chapters in Textbooks:
`
`1)
`
`2)
`
`3)
`
`4)
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`5)
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`6)
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`7)
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`8)
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`9)
`
`"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. .0:, Marcel Dekker, Inc., NY, pp. 217-308, (1986).
`
`in Pharmaceutical Dosage Forms: Parenteral Medications, Second
`"Particulate Matter"
`Edition, Vol. ill Marcel Dekker, Inc., N.Y., pp. 117-230 (1993).
`
`"Fonnulation Development ofSmaH and Large Volume Injections", Madhav Karnat and Patrick P.
`DeLuca, in Pharmaceutical Dosage Forms, Parenteral Medications, Third Edition, Voll1, chap 5
`Marcel Dekker, (2010).
`
`"Lipid Nanoparticulate Drug Delivery and Nanomedicine''', Heidi M. Mansour, Yun-Seok Rhee,
`Chun-Woong Park and Patrick P. DeLuca, pending published in American Oil Chemists
`Society, (201 1)
`
`"Novel Drug Delivery Systems" Chapter 5 in "Drug Delivery" I st Ed. 201 5, Heidi M.
`Mansour, Zhen Xu, Samantha A. Meenach, Chun-Woong Park, Yun-Seok Rhee, and
`Patrick P. DeLuca, 0 1/2015; pages 71-107; ISBN 9781284025682
`
`Articles in P rofessional 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
`
`4
`
`Exh. 1041
`
`

`
`Pharmaceutical Industry, October 1971. Published in the "Wisconsin Phannacist ,
`(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, J.L.,
`DeLuca, P.P., and Straus, R., Pharmacy Times 69968-74, Oct. (1976).
`
`Minimizing Contamination During LV. Therapy by In-line Filtration, DeLuca, P.P.,
`Rapp, R.P., and Bivins, B., Western States LV. Therapy Journal, 5-14, Sept.-Oct.
`(1976).
`
`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
`ofKentucky, Im, S., and DeLuca, P.P., Am. J. Phann. 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
`Roffman-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. LV. Ther. Clin. Nutr., 1:36-46 (1980).
`
`Bridging the Gap Between the Basic Sciences and Clinical Practice: Teaching, Research
`and Services. The Importance ofDefming Institutional Goals. Swintosky, LV., DeLuca,
`P.P., Parker, P.F., and Gueryant 1., 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., 10111 International Pharm Tech
`Symposiwn, in press, Minutes, Editions De Sante, Paris, (200 1 ).
`
`2)
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`3)
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`4)
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`5)
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`6)
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`7)
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`8)
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`9)
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`10)
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`11)
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`12)
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`13)
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`14)
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`15)
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`16)
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`5
`
`Exh. 1041
`
`

`
`Articles in Scientific Journals:
`
`1)
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`2)
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`3)
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`4)
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`5)
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`6)
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`7)
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`8)
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`9)
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`10)
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`11)
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`12)
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`13)
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`14)
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`15)
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`16)
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`17)
`
`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 ofPreservatives witlh 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 ofRiboflavin to Macromolecules in Aqueous Solution, DeLuca, P.P. and
`Kostenbauder, H.B., J. Phys. Chern., 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).
`
`Lyophilization ofPharmaceutical I. Effect of Certain Physical-chemical Properties, DeLuca, P.P.
`and Lachman, L., J. Pharm. Sci., 54, 617 (1965).
`
`Lyophilization ofPharmaceuticals II. High-Sensitivity Resistance Bridge for Low-Conductivity
`Measurements at Eutectic Temperatures, Lachman, L., DeLuca, P.P., Withnell, R., J. Pharm. Sci.,
`.2±,. I 342 (I 965).
`
`Lyophilization ofPharmaceuticals III. Programming of Mathematical Expression ofEstimating
`Eutectic Temperatures from Melting Point and Solubility Parameters, DeLuca, P.P., Lachman, L.,
`Yost, W., J. Pharm. Sci., 54, 1348 (1965).
`
`Lyophilization ofPharmaceuticals TV. Determination of Eutectic Temperatures oflnorganic Salts,
`DeLuca, P.P. and Lachman, L., J. Pharm. Sci., .2..1.. 1411 (1965).
`
`Lyophilization ofPharmaceuticals V. Influence ofMetal Trays on Health Transfer During
`Lyophilization, DeLuca, P.P. and Lachman, L., Bull. Parenter. Drug Assoc., 20, 65 (1966).
`
`Photobinding and Photoreactivity ofRiboflavin in the Presence ofMacromolecules, Kostenbauder,
`H.B., DeLuca, P.P., Kowarski, C.R., J. Pharm. Sci., .2..1.. 1244 (1965).
`
`Modified Computer Programs for Detennining Eutectic Temperatures, DeLuca, P.P., Lachman, L.,
`Yost, W., Clements, I.A., Rogers, A.R., J. Pharm., Sci., 22,. 450 (1966).
`
`Manufacturing Aspects ofPrefiilled 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 Progranuning Production
`Cycles, DeLuca, P.P., J. Phann. Sci., QQ, 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., 22... 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, J.D., Cloys, D., Parenteral Drug Association
`Research Award winning paper for 1972, Bull. Parenter. Drug Assoc., 27, I ( 1973).
`
`6
`
`Exh. 1041
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`

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`18)
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`19)
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`20)
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`21)
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`22)
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`23)
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`24)
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`25)
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`Physical-Chemical Properties of Substituted Am ides 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, l (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, Rusrnin, S. and DeLuca, P.P., Am. J. Hosp. Pharm., 32, 378-80 (1975).
`
`In-line Filtration ofi.V. Fluids and Drugs, Rapp, R.P., Bivins, B., DeLuca, P.P., Am. J. of IV Ther.,
`Z, 18-23 (1975).
`
`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. Chern., 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).
`
`26) Membrane Filters: Additional Safety for Intraarterial Infusions, Meeker, W.R., Rapp, R.P., DeLuca,
`P.P., Bivins, B., Arch. Surg., ill, 20 L (1976).
`
`27)
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`28)
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`29)
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`30)
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`31)
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`32)
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`33)
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`34)
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`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 (I 976).
`
`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, LN., DeLuca,
`P.P., Am. J. Hosp. Pharm., TI, 546-51 (1976).
`
`The Dielectric Constant and Dipole Moment ofN,N,N'N' Tetramethylpimelamide at 25°C., DeLuca,
`P.P., Rebagay, T.V., Casteel, 1., J. of Chern. & Engr. Data, ZL 262-64 (1976).
`
`Correlation of Dielectric Constant and Solubilizing Properties ofTetramethyldicarboxarnides,
`Rebagay, T. and DeLuca, P.P., J. Pharm. Sci., 65(1 1), 1645-48 (1976).
`
`7
`
`Exh. 1041
`
`

`
`35)
`
`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 .. .ll(l), 1-8 (1977).
`36) Freeze Drying of Pharmaceuticals, DeLuca, P.P., J. Vac. Sci. & Technol., H., 620-29 (1977).
`
`37)
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`38)
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`39)
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`40)
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`41)
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`42)
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`43)
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`44)
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`45)
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`46)
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`47)
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`48)
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`49)
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`50)
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`51)
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`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., .ll(2), 57-69 (I 977).
`
`Particulate Matter Monitoring II. Correlation of Microscopic and Automatic Counting Methods,
`Rebagay, T.V., Schroeder, H. G., DeLuca, P.P., Bull Parenter Drug Assoc., .ll(3), 150-55 (1977).
`
`Inflammatory Potential of Foreign Particulates in Parenteral Drugs, Dorris, G. C., Bivins, B.A.,
`Rapp, RP., Weiss, D.L., DeLuca, P.P., Ravin, M.B., Anesth. Analg., 56(3), 422-28 (1977).
`
`Effect of In-line Filtration on the Potency of Drugs Administered Intravenously, Rusmin, S., Welton,
`S., DeLuca, P., DeLuca, P.P., Am. J. Hasp. Pharm., 34, 1071-74 (1977).
`
`Research and Development ofPharmaceutical Dosage Forms, International Symposium on
`Freeze-drying ofBiological Products, Washington, DC, 1976, DeLuca, iP.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.,
`Jl(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
`(197R).
`
`Sustained-Release From Inert Wax Matrixes 1: Drug-Wax Combinations, Schroeder, H. G., Dak.kuri,
`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 lnert Wax Matrices ITl: Effect of Povidone on Tripelennamine
`Hydrochloride Release, Dakkuri, A., Butler, L.D., DeLuca, P.P., J. Pharm. Sci. 67:(3), 357-360
`(1978).
`
`Distribution ofRadiolabeled 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 M icrospheres Administered Intravenously to Beagle Dogs,
`Schroeder, H.G., Bivins, B.A., Sherman, G.P., DeLuca, P.P., J. Pharm. Sci., 67(4), SOR-13 (197R).
`
`A Note on the Acute Toxicity of Substituted Amide Solvents, Sherman, G.P., Gatlin, L., DeLuca,
`P.P., Drug Dev. Ind. Pharm., 1(5), 485-89 (1978).
`
`Final In-line Filtration: A Means of Decreasing the Incidence of Infusion Phlebitis, Bivins, B.A.,
`Rapp, RP., 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. Hasp. Pharm., 36, 749-53 (1979).
`
`8
`
`Exh. 1041
`
`

`
`52)
`
`53)
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`54)
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`55)
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`56)
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`57)
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`58)
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`59)
`
`60)
`
`61)
`
`62)
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`63)
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`64)
`
`65)
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`66)
`
`Colorimetric Determination of Penicillins and Related Compounds in I.V. Solutions by Nickel (II)-
`Catalyzed Hydroxamic Acid Fonnulation Munson, 1., Papadirnitriou, D., DeLuca, P.P., J. Pharm.
`Sci., 68(10), 1333-35 (1979).
`
`Determining Osmolarities: A Practical Approach for Multicomponcnt 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 ofVenous
`Pore Size, Rapp, R.P., Bivins, B.A., DeLuca, P.P., Am. J. Hosp. Pharm .. 36, 1711 (1979).
`
`Identification of Subvisible Bariiun1 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), 183-9 I ( 1980).
`
`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. I , 45, France, June (1980).
`
`The Fate and Effects of 141Ce Labeled Microspheres Following LV. or I.A. Administration in
`Beagle Dogs, DeLuca, P.P., Kanke, M., Bivins, B., Slack, J., Simmons, G., Yokel, R., Schroeder, H.,
`Sniecinski, 1., APGI Proceedings 2nd International Conference on Pharmaceutical Technology Vol.
`IL 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 ofReducing 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 ofParticulates in Parenteral Products, DeLuca, P.P., 1m, S., Boddapati, S., APGI
`Proceedings 2nd International Conference on Pharmaceutical Technology Vol IV, 199, France, June
`(1980).
`
`Clearance ofCe-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 ofParticles in Parenterals, DeLuca, P.P., Boddapati, S., Im, S., FDA
`Bylines, lQ, 111-165 ( 1980).
`
`A Study ofPhase Transitions in Frozen Antibiotic Solutions by Differential Scanning Calorimetry,
`Gatlin, L. and DeLuca, P.P., J. Parenter. Drug Assoc., 34(5), 398-408, (1980).
`
`9
`
`Exh. 1041
`
`

`
`67)
`
`68)
`
`69)
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`70)
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`71)
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`72)
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`73)
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`74)
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`75)
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`76)
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`77)
`
`78)
`
`79)
`
`80)
`
`81)
`
`82)
`
`Theoretical Aspects of Sterile Filtration and Integrity Testing, Schroeder, H.G. and DeLuca, P.P.,
`Pharm. Tech., .1(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, 1., DeLuca, P.P., Toxicol.
`Lett., 2, 165-170 (1981).
`
`The Application ofProposed Procedures for Testing for Extractables in Plastic Containers, DeLuca,
`P.P., Papadimitriou, D., DeLuca, P.P., J. Parenter. Sci. Teclmol., 36(1), 28 (1982).
`
`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 N, p. 152-161, France, ( 1983).
`
`Interaction ofMicrospheres with Blood Constituents and Effect on Immune Response, Kanke, M.,
`Sniecinski, 1., DeLuca, P.P., APGI Proceedings 3rd International Conference on Pharmaceutical
`Teclmology. 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
`Tnfusates, Athanikar, N.K., Jurgens, R.W., Sturgeon, R.T., DeLuca, P.P., Papadimitriou, D., L
`Parenter. Sci. Techno!., 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. Pharrn., 40, 1323-1328 (1983).
`
`Interaction ofMicrospheres with Blood Constituents: I. Uptake of Polystyrene Spheres by
`Monocytes and Granulocytes and Effect on Immune Responsiveness of Lymphocytes, Kanke, M.,
`Sniecinsk:i, 1.1., DeLuca, P.P., J. Parenter. Sci. Techno!., 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 ofCoated Polymethyl[2-14C] Methacrylate Nanoparticles after N
`Injection in Rats, Leu, D., Manthey, B., Kreuter, 1., Speiser, P., DeLuca, P.P., J. Pharm. Sci., 73(10),
`1433-37 (1984).
`
`Osmolality of Small-Volume lnltravenous Admixtures, Wermeling, D.P., Rapp, R.P., DeLuca, P.P.,
`Piecoro, 1.1., 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. Pharrn., 43, 81-88 (1986).
`
`Interaction ofMicrospheres with Blood Constituents: Il Uptake of Biodegradable Partides by
`Macrophages, Kanke, M., Mortier, E., Geissler, P., Powell, D., Kaplan, A., DeLuca, P.P., J. Parenter.
`Sci. Techno!.. 40, 114-118 (1986).
`
`10
`
`Exh. 1041
`
`

`
`83)
`
`84)
`
`85)
`
`86)
`
`87)
`
`88)
`
`89)
`
`90)
`
`91)
`
`92)
`
`93)
`
`94)
`
`95)
`
`96)
`
`97)
`
`An Approach of Setting Particulate Matter Standards for Small Volume Parenterals, DeLuca, P.P.,
`Boddapati, S., Haack, D., Schroeder, H., J. Parenter. Sci. Techno!., 40, 2-13 (1986).
`
`The Investigation ofPVP 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 ofKentucky, 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, 1.,
`Proceedings of the International Conference on Liquid Borne Particle Inspection and Metrology, p.
`376, Parenteral Drug Association, Philadelphia, PA, (1987).
`
`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., l , 21 (1988).
`
`Review of Commercially Available Particulate Measurement Systems, Part 1: Instrumentation,
`Knapp, I.Z. and DeLuca, P.P., J. Parenter. Sci. Techno!., 42(15) Tech. Report #9, S3 (1988).
`
`Review of Commercially Available Particulate Measurement Systems, Part IT: A Selected
`Annotated Bibliography on Particulate Matter, DeLuca, P.P., Conti, B., Knapp, J.Z., J. Parenter. Sci.
`Tech not., 42(1 5), Tech Report #9, 519 (1988).
`
`The Effect of Solvent Addition and Thermal Treatment on the Freeze Drying ofCefazolin Sodium.
`Koyama, Y., Kamat M., DeAngelis, R.I., Srinivasan, R., DeLuca, P.P., J. Parenter. Sci. Techno!.,
`42(2), 47-52 (1988).
`
`Hygroscopicity ofCefazolin Sodium: Application to Evaluate Crystallinity ofFreeze Dried Product,
`Osawa, T., Kamat, M., DeLuca, P.P., Pharm. Res., ~ (7), 421-425 (1988).
`
`Estimation of the Degree of Crystallinity ofCefazolin Sodium by X-ray and Infrared Methods,
`Kamat, M., Osawa, T., DeAngelis, R.I., Koyama, Y., DeLuc-a, P.P., Pharm., Res., l(7), 426-429
`( 1988).
`
`Interaction ofMicrospheres with Blood Constituents ill. Macrophage Phagocytosis of Various Types
`ofPolymeric Drug Carriers, Kanke, M., Geissler, R.G., Powell, D., Kaplan, A., DeLuca, P.P., L
`Parenter. Sci. Technol., 42(5), 157-165 (1988).
`
`The Use ofLyoprotectants in the Freeze Drying of a Model Protein, Ribonuclease A, Townsend,
`M.W. and DeLuca, P.P., J. Parenter. Sci. Techno!., 42(6), 190-199 (1988).
`
`Cleanliness Assessment of Supplier-Cleaned Rubber Closures