Dr. Remington (seated right) reading galley proof. Galley proofs of USP monographs hang on the far wall, and USP Circulars are being
`•
`collated on the billiard table.
`
`MPI EXHIBIT 1069 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0001
`
`

`

`{
`rl
`J
`
`d
`:,f
`5.
`
`2 0 TH EDITION
`
`Remington: The
`Science and
`Practice
`of Pharmacy
`
`Volume I
`
`ALFONSO R GENNARO
`Chairman of the Editorial Board
`and Editor
`
`INTERNATIONAL STUDENTEDITION
`
`,~ LIPPINCOTT WILLIAMS & WILKINS
`A Wolters Kluwer Company
`•
`Philadelphia • Baltimore • New York • London
`Buenos Aires • Hong Kong • Sydney • Tokyo
`
`MPI EXHIBIT 1069 PAGE 2
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0002
`
`

`

`Editor: Daniel Limmer
`Managing Editor: Matthew J. Hauber
`Marketing Manager: Anne Smith
`
`Lippincott Williams & Wilkins
`
`351 West Camden Street
`Baltimore, Maryland 21201-2436 USA
`
`227 East Washington Square
`Philadelphia, PA 19106
`
`All rights reserved. This book is protected by copyright. No part of this book may
`be reproduced in any form or by any means, including photocopying, or utilized
`by any information storage and retrieval system without written permission
`from the copyright owner.
`
`The publisher is not responsible (as a matter of product liability, negligence or
`otherwise) for any injury resulting from any material cr;mtained herein. This
`publication contains information relating to general principles of medical care
`which should not be construed as specific instructions for individual patients.
`Manufacturers' product information and package inserts should be reviewed for
`current information, including contraindications, dosages and precautions.
`
`Printed in India at Gopsons Papers Ltd., Noida
`Reprinted, 2001
`
`Entered according to Act of Congress, in the year 1885 by Joseph P Remington,
`in the Office of the Librarian of Congress, at Washington DC
`
`Copyright 1889, 1894, 1905, 1907, 1917, by Joseph P Remington
`
`Copyright 1926, 1936, by the Joseph P Remington Estate
`
`Copyright 1948, 1951, by the Philadelphia College of Pharmacy and Science
`
`Copyright 1956, 1960, 1965, 1970, 1975, 1980, 1985, 1990, 1995, by the Phila(cid:173)
`delphia College of Pharmacy and Science
`
`Copyright 2000, by the University of the Sciences in Philadelphia
`
`All Rights Reserved
`Library of Congress Catalog Card Information is available
`ISBN 0-78 l 7-200X-4
`
`The publishers have made every effort to trace the copyright holders for borrowed
`material. If they have inadvertently overlooked any, they will be pleased to make
`the necessary arrangements at the first opportunity.
`
`The use of structural formulas from USAN and the USP Dictionary of Drug
`Names is by permission of The USP Conve;Ltion. The Convention is not respon(cid:173)
`sible for any inaccuracy contained herein.
`Notice-This text is not intended to represent, nor shall it be interpreted to be, the
`equivalent of or a substitute for the official United States Pharmacopeia (USP)
`and/or the National Formulary (NF). In the event of any difference or discrep·
`ancy between the current official USP or NF standards of strength, quality,
`purity, packaging and labeling for drugs and representations of them herein, the
`context and effect of the official compendia shall prevail.
`
`To purchase additional copies of this book call our customer service department
`at (800) 638-3030 or fax orders to (301) 824-7390. International customers
`should call (301) 714-2324.
`
`00 01 02 03 04
`12345678910
`
`This edition is manufactured in India and is authorised for sale
`only in India, Bangladesh, Pakistan, Nepal and Sri Lanka.
`
`MPI EXHIBIT 1069 PAGE 3
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0003
`
`

`

`Remington: The Science and Practice of Pharmacy . . . A treatise on the theory
`and practice of the phormoceuticol sciences, with essential
`information about pharmaceutical and medicinal agents; also, 0
`guide to the professional responsibilities of the pharmacist as the
`drug information specialist of the health team ... A textbook and
`reference work for pharmacists, physicians, and other practitioners of
`the phormoceuticol and medical sciences.
`
`EDITORS
`
`Alfonso R Gennaro, Choir
`
`Nicholas G Popovich
`
`Aro H Der Morderosian
`
`Glen R Hanson
`
`Thomas Medwich
`
`Roger L Schnoore
`
`Joseph 0 Schwartz
`
`H Steve White
`
`AUTHORS
`
`The 119 chapters of this edition of Remington w~re written by the
`
`editors, by members of rhe Editorial 13oord, and by the authors
`
`listed on pages viii to x.
`
`Managing Editor
`
`John E Hoover, 135c ( Pharm)
`
`Editorial Assistant
`
`13onnie 13righom Pocl,;er, RNC, 13A
`
`Director
`
`Philip P Gerbino 1995-2000
`
`Twentieth Edition-2000
`
`Published in the 180th year of the
`PHILADELPHIA COLLEGE OF PHARMACY AND SCIENCE
`
`MPI EXHIBIT 1069 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0004
`
`

`

`Remington Historicol/Diogrophicol Doto
`
`The following is a record of rhe editors and rhe dares of publication of successive editions of rhis booh, prior ro the 1 Jth
`Edirion I,nown os r.emingron's Procrice of Pharmacy and subsequently os Remington's Pharmaceutical Sciences
`through the 19th Edition.
`
`First Edition, 1886
`Second Edition, 1889
`Third Edition, 1897
`Fourth Edition, 1905
`Fifth Edition, 1907
`Sixth Edition, 1917
`
`Seventh Edition, 1 926
`
`Edi.tors
`E Fullerton Cool,
`Cliorles H LoWoll
`
`Eighth Edition, 1906
`
`Editors
`E Fullerton Cool,
`Charles H LoWoll
`
`Ninth Edition, 1948
`Tenth Edition, 1951
`
`Eleventh Edition, 1956
`
`Editors
`Eric W Mortin
`E Fullerton Cool,
`
`Twelfth Edition, 1961
`
`Editors
`Eric W Martin
`E Fullerton Cool,
`E Emerson Leuallen
`Authur Osol
`Linwood F Tice
`Clarence T Von Merer
`
`Thirteenth Edition, 1965
`
`Editor-in-Chief
`Eric W Martin
`Editors
`Grafton D Chose
`Herald P, Cox
`P.ichord A Deno
`Alfonso P, Gennaro
`Stewart C Harvey
`
`Fourteenth Edition, 1970
`
`Chairman, Editorial Doord
`Arthur Osol
`Editors
`Grafton D Chose
`Richard A Deno
`Alfonso R Gennaro
`Me/yin R Gibson
`Stewart C Harvey
`
`Joseph P P.emington
`
`Fifteenth Edition, 1975
`
`Joseph P P.emington
`Assisted by
`E Fullerton Cool,
`
`Associate Editors
`Ivor Griffith
`Adley [3 Nichols
`Arthur Osol
`
`Editors
`E Fullerton Cool,
`Eric W Martin
`
`Associate Editors
`E Emerson Leuallen
`Arthur Osol
`Linwood F Tice
`Clarence T Van Merer
`
`Assisranr to rhe Editors
`John Hoover
`
`Managing Editor
`John E Hoover
`
`Robert E King
`E Emerson Leuollen
`Authur Osol
`Ewart A Swinyord
`Clarence T Von Meter
`
`Managing Editor
`John E Hoover
`
`Robert E King
`Alfred N Martin
`Ewart A Swinyord
`Clarence T Van Meter
`
`Chairman, Editorial Doard
`Arthur Osol
`Editors
`John T Anderson
`Cecil L [3endush
`Grafton D Chase
`Alfonso P, Gennaro
`Melvin R Gibson
`
`Sixteenth Edition, 1980
`
`Chairman, Editorial Doard
`Arthur Osol
`Editors
`Grafton D Chase
`Alfonso P, Gennaro
`Melvin R Gibson
`
`Sev.enteenth Edition, 1 985
`
`Chairman, Editorial Doard
`Alfonso P, Gennaro
`Editors
`Grafton D Chase
`Ara H Der Marderosian
`Stewart C Harvey
`Daniel A Hussar
`Thomas Medwicl,
`
`Eighteenth Edition, 1990
`
`Chairman, Editorial Doard
`Alfonso R Gennaro
`
`Editors
`Grafton D ChosE;>
`Ara H Der Marcierosian
`"
`Stewart C Harvey
`Daniel A Hussar
`Thomas Medwicl,
`
`Nineteenth Edition, 1995
`
`Chairman, Editorial Doord
`Alfonso R Gennaro
`
`Editors
`Grafton D Chase
`Aro H Der Marderosian
`Glen R Hanson
`Doniel A Hussar
`Thomas Medwicl,
`
`Managing Editor
`John E Hoover
`
`C [30yd Granberg
`Stewart C Harvey
`Robert E King
`Alfred N Mortin
`Ewart A Swinyard
`
`C [30yd Granberg
`Stewart C Harvey
`Robert E King
`Alfred N Martin
`Ewart A Swinyord
`Gilbert L Zink
`
`Managing Editor
`John E Hoover
`
`Edward G Rippie
`Joseph D Schwartz
`Ewart A Swinyard
`Gilbert L Zin!,
`
`Managing Editor
`John E Hoover
`Editorial Assistant
`0onnie Pacl,er
`
`Edward G Rippie
`Joseph D Schwartz
`Ewart A Swinyard
`Gilbert L Zink
`
`Managing· Editor
`John E Hoover
`Editorial Assistant
`[Jonnie Pocl,er
`
`Edward G Rippie
`Joseph D Schwartz
`H Steve White
`Gilbert l Zink
`
`vi
`
`MPI EXHIBIT 1069 PAGE 5
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0005
`
`

`

`Editorial Board Members and Editors
`
`Alfonso R Oennaro, PhD/ University of the Sciences in Philodelphio-Professor of Chemistry. Choir, Editorial
`Ooord ond Editor. Coeditor of Port 6, Phormocodynomics, ond Port 7, Pharmaceutical and
`Medicinal Agents. Coauthor o: Chapter 25.
`
`Ara H Der Marderosian, PhD / University of the Sciences in Philodelphio-Professor of Phormocognosy and
`Medicinal Chemistry, Scientific Director, Complementary and Alternative Medicine Institute. Editor
`of Port 1 , Orientation. Coauthor of Chapters 7, 4 9, and 1 OJ.
`
`Glen R Hanson, DDS, PhD/ College of Pharmacy and School of Medicine, University of Utah-Professor of
`Pharmacology and Toxicology.· Coeditor of Port 6, Phormocodynomics, and Port 7 Pharmaceutical
`and Medicinal Agents. Author of Chapters 75, 76, and 83 ..
`
`Thomas Medwick, PhD / Rutgers University College of Pharmacy-Professor Emeritus, Deportment of
`Pharmaceutical Chemistry. Editor of Port J, Pharmaceutical Chemistry, and Port 4, Pharmaceutical
`Testing, Analysis, and Control. Author of Chapter 24. Coauthor of Chapter JO.
`
`Nicholas G Popovich, PhD / Purdue University, School of Pharmacy and Pharmocol Sciences-Professor of
`Pharmacy Practice. Editor of Port 8A, Pharmacy Administration, Port 8[3, Fundamentals of
`Pharmacy Practice, and Part 8C, Patient Core. Coauthor of Chapter 101.
`
`Roger L Schnaare, PhD / University of the Sciences in Philadelphia, Philadelphia College of Pharmacy._,.
`Professor of Pharmacy, Department of Pharmaceutics. Editor of Part 2, Pharmaceutics. Coauthor
`of Chapter 11 .
`
`Joseph D Schwartz, PhD/ University of the Sciences in Philadelphia, Philadelphia College of Pharmacy.
`Ourroughs-Wellcome Fund Professor of Pharmaceutics, Director of Pharmacy Research. Editor of
`Part 5, Phormoceuticol Manufacturing. Coauthor of Chapters 37 and 45.
`
`ff Steve White, PhD / Colfege of Pharmacy, University of Utah-Associate Professor of Pharmacology and
`Toxicology. Coeditor of Parr 6, Pharmacodynomics, and Port 7, Pharmaceutical and Medicinal
`Agents. Author of Chapters 74, 79, 80, 81, 84, and 88.
`
`vii
`
`MPI EXHIBIT 1069 PAGE 6
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0006
`
`

`

`Authors
`
`Marie A Abate, PharmD / Professor and Associate Chair of
`Clinical Pharmacy, School of Pharmacy, West Virginia Uni(cid:173)
`versity. Coauthor of Chapter 9, Clinical Dru!{ Literature.
`Hamed M Abdou, PhD/ President, Worldwide Pharmaceutical
`Technical Operations, Bristol-Myers Squibb, Lawrenceville,
`NJ. Coauthor of Chapter 34, f11strume11tal Methods of Anal(cid:173)
`ysis. and Chapter 35. Dis.~olution.
`Mignon SAdams/ Director of Library and Information Services,
`Joseph W England Library, University of the Sciences in
`Philadelphia. Coauthor Chapter 8, Information Resources in
`Pharmacy and the Pharmaceutical Sciences.
`Loyd V Allen, Jr, PhD / Professor Emeritus, Department of
`Medicinal Chemistry and Pharmaceutics, College of Phar(cid:173)
`macy, University of Oklaboma. Author of Chapter 98, Extem(cid:173)
`poraneous Prescription Compounding.
`Howard Y Ando, PhD/ Director, Discovery Lead Optimization,
`Pfizer Global R&D, Ann Arbor Laboratories, Pfizer, Inc, Ann
`• Arbor, MI. Coauthor of Chapter 38, Preformulation.
`Kenneth E Avis, DSe* / Emeritus Professor, Phannaceutical Sci(cid:173)
`ences, College of Pharmacy, University of Tennessee, Memphis.
`Coauthor of Chapter 41, Parenteral Preparations, and Chap~r
`118, Aseptic Technology for Home-Care Pharmaceutical~.
`Leonard C Bailey, PhD / Professor of Pharmaceutical Chemis(cid:173)
`try, Rutgers University College of Pharmacy. Author of
`Chapter 33, Chromatography.
`Jan N Bair, PhD/ Professor Emeritus of Hospital Pharmacy,
`College of Pharmacy, University of Utah. Author of Chapter
`64, Diagnostic Drugs and Reagent~.
`Louis R Barrows, PhD / Professor of Pharm&cy and Toxicology,
`College of _Pharmacy, University of Utah. Author of Chapter
`86, Antineoplastic and lmmunoactive Drugs.
`Sara Beis, MS/ Pharmacy Management Consultant. Coauthor of
`Chapter 117, Integrated Health-Care Delivery Systems.
`Lawrence H Block, PhD / Professor of Pharmaceutics, Du(cid:173)
`quesne University School of Pharmacy. Author of Chapter
`44, Medicated Topicals.
`Sanford Bolton, PhD/ Visiting Professor, Department of Phar(cid:173)
`macy, University of Arizona. Author of Chapter 12, Statistics.
`Leslie Ann Bowman, BA / Coordinator of Instructional Ser(cid:173)
`vices, Joseph W England Library, University of the Sciences
`in Philadelphia. Coauthor Chapter 8, Information Resources
`in Pharmacy and the Pharmaceutical Sciences.
`Dara C Bultman, PhD / Program Manager, Medical Media
`Associates, Inc. Coauthor of Chapter 113, The Patient: Be(cid:173)
`havioral Determincmts.
`Paul M Bummer, PhD / Associate Professor of Pharmaceutical
`Sciences, College of Pharmacy, University of Kentucky. Au(cid:173)
`thor Chapter 20, Interfacial Phenomena.
`Karleen S Callahan, PhD/ Research Assistant Professor of Phar(cid:173)
`macology, College of Pharmacy, University of Utah. Coauthor of
`Chapter 67, Blood, Fluids, Electrolytes, and Hematologic Drugs.
`Patrick N Catania. PhD / Professor and Chairman, Department
`of Pharmacy Practice, School of Pharmacy, University of the
`Pacific. Author Chapter 118, Home Jli'alth Pnlil'nt C(lrc.
`Amy Christopher/ Coordinator of Outreach Services, Jo8epi1 W
`England Library, University of the Sciences in Philadl0 lphia.
`Coauthor Chapter 8, Information Resources in Phurn,acy
`and the Pharmaceutical Sciences.
`Kenneth A Connors, PhD / Professor Emeritus of Pharmaceu(cid:173)
`tics, School of Pharmacy, University of Wisconsin. Author of
`Chapter 14, Complex Formation.
`Clarence A Discher, PhD* / Professor Emeritus, Rutgers
`University.
`William R Doucette, PhD / Associate Professor, College of
`Pharmacy, University of Iowa. Coauthor of Chapter 92, Mar(cid:173)
`keting Pharmaceutical Care Serriices.
`Victoria E Doyle, CIH, MPH / Environmental and Occupa(cid:173)
`tional Health Sciences Institute UMD School of Public
`Health. Coauthor Chapter 107, Pesticides.
`John E Enders, PhD, MBA / Director of Quality Assurance,
`Delmont Laboratories, Swarthmore, PA. Author of Chapter
`51, Quality Assurance and Control.
`
`•Deceased.
`
`Joseph L Fink III, BSPharm, JD/ Assistant Vice President for
`Research and Graduate Studies, Professor of Pharmacy, Col(cid:173)
`lege of Pharmacy, University of Kentucky. Author Chapter 1.
`Scope of Pharmacy, and Coauthor of Cha pt.er 90, Laws Gm,(cid:173)
`emil'lll Pharmacy.
`Annette E Fleckenstein, PhD/ Assisi.ant Professor of Pharma(cid:173)
`cology and Toxicology, University of Utah. Author of Chapter
`63, Pharmacological Aspects of Substance Abuse, and Chap(cid:173)
`ter 72, Adrenergie Antagonists and Adrenergic Neuron Block(cid:173)
`ing Drugs.
`Michael R Franklin, PhD / Professor of Pharmacology, College
`of Pharmacy and School of Medicine, University of Utah.
`Coauthor of Chapter 57, Drug Absorption, Action, and Dis(cid:173)
`position, and Author of Chapter 105, Enzymes.
`Donald N Franz, PhD/ Professor of Pharmacology and Toxicol(cid:173)
`ogy, School of Medicine, University of Utah. Coauthor of
`Chapter 68, Cardiovascular Drugs, Chapter 71, Cholinomi(cid:173)
`metic Drugs, and Chapter 73, Antim11cscarinic and Antispas(cid:173)
`modic Drugs.
`Ruta Freimanis, PharmD, RPh / Secretary, United States
`Adopted NamC's Council, Chicago, IL. Author of Chapter 27,
`Drug Nomenclature-United States Adopted Names.
`Raymond E Galinsky, PharmD / Professor, Department of
`Industrial and Physical Pharmacy, School of Pharmacy and
`Pharmacal Sciences, Purdue University. Coauthor of Chap(cid:173)
`ter 58, Basic Pharmacokinetics.
`Barry D Garfinkle, PhD/ Vice President, Vaccine Technology
`and Engineering, Manufacturing Division, Merck & Co, Inc,
`West Point, PA. Coauthor of Chapter 40, Sterili:tation.
`Harold N Godwin, PhD / Professor and Director of Pharmacy,
`The University of Kansas Medical Center. Author of Chapter
`111, Institutional Patient Care.
`Martin C. Gregory, BM, BCh, DPhil / Professor, Division of
`General Internal Medicine, School of Medicine, University of
`Utah. Coauthor of Chapter 56, Diseases: Manifestations and
`Pathophysiology.
`Pardeep K Gupta, PhD / Associate Professor, Philadelphia
`College of Pharmacy, University of the Sciences Jn Philadel(cid:173)
`phia. Author of Chapter 16, Solutions and Phase 'Equilibria.
`Samir Hanna, PhD / Vice President (Retired), Worldwide Qual(cid:173)
`ity Control and Bulk Quality Assurance, Bristol-Myers
`Squibb, Syracuse, NY. Coauthor of Chapter 34, Instrumental
`Methods of Analysis, and Chapter 35, Dissolution.
`Gerald Hecht, PhD/ Senior Director, Pharmaceutical Sciences,
`Alcon Laboratories, Fort Worth, TX. Author of Chapter 43,
`Ophthalmic Preparations.
`Martin W Henley, MSc / Coauthor of Chapter 40, Sterilization.
`Merk & Co, Inc, West Point, PA, (Retired)
`Daniel A Herbert, RPh, FACA / President and CEO, Richmond
`Apothecaries, Inc. Coauthor Chapter 4, Community Phar(cid:173)
`macy Practice.
`Gregory J Higby, PhD/ Director, American Institute of the
`History of Pharmacy, School of Pharmacy University of Wis(cid:173)
`consin. Author of Chapter 2, Evolution of Pharmacy.
`James R Hildebrand III, PharmD / Target Research Associ(cid:173)
`ales. Philadelphia. Coauthor of Chapter 9, Clinical Drug
`literature.
`William B Hladik III, MS / Associate Professor, College of
`Pharmacy, University of New Mexico Health Sciences Cen(cid:173)
`ter. Coauthor of Chapter 29, Fundamentals of Me€lical
`Radionuclides.
`Daniel A Hussar, PhD / Remington Professor of Pharmacy,
`Philadelphia College of Pharmacy, University of the Sciences
`in Philadelphia. Author of Chapter 102, Drug Interactions,
`and Chapter 115, Patient Compliance.
`Timothy J Ives, PharmD, MPH/ Associate Professor of Phar(cid:173)
`macy and Clinical Associate Professor of Family Medicine,
`University of North Carolina. Coauthor of Chapter 7, Phar(cid:173)
`macists and Public Health.
`Joel O Johnson, MD PhD / Associate Professor of Clinical
`Anesthesiology, and Neurosurgery, School of Medicine, Uni(cid:173)
`versity of Missouri-Columbia. Author Chapter 78, General
`Anesthetics.
`
`MPI EXHIBIT 1069 PAGE 7
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0007
`
`

`

`Russell Katz, MD/ Deputy Director, Division of Neuropharma(cid:173)
`cological Drug Products, Center for Drug Evaluation and
`Research, Food and Drug Administration, Rockville, MD.
`Author of Chapter 48, The Introduction of New Drugs.
`Kristin A Keefe, PhD / Assistant Professor, Department of
`Pharmacology an<l Toxicology, College of Pharmacy, Univer(cid:173)
`sity of Utah. Author of Chapter 70, Sympathomimetic Drugs.
`Calvin H Knowlton, RPh, MDiv, PhD, FACA / CEO, Hospice
`Pharmacia, Inc. Coauthor of Chapter 4, The Practice of Com(cid:173)
`munity Pharmacy.
`Richard W Knueppel, RPh / President, Knµeppel Health Care
`Services, Inc. Author of Chap'ter 9, Health Accessories.
`Kristine Knutson, PhD/ Associate Professor of Pharmaceutics,
`College of Pharmacy, Univernity uf Utah. Coauthor of Chap(cid:173)
`ter 65, Topical Drugs.
`Allen M Kratz, PharmD / President, HVS Laboratories, Inc.
`Coauthor of Chapter 103, Complementary and Alternative
`Medical Health Care.
`David J Kroll, PhD / Associate Professor of Pharmacology and
`Toxicology, Center for Pharmaceutical Biotechnology, Uni(cid:173)
`versity of Colorado School of Pharmacy. Coauthor of Chapter
`49, Biotechnology and Drugs.
`•
`Arthur J Lawrence, PhD/ Rear Admiral, Assistant Surgeon
`General, Office of the Assistant Secretary for Health and
`Surgeon General. Author of Chapter 6, Pharmacists in
`Government.
`Thomas Wai-Yip Lee, BPharm / Research Assistant, School of
`Pharmacy, University of Wisconsin. Assistant on Chapter 47,
`Controlled-Release Drug-Deliuery Systems.
`John W Levchuk, PhD / Captain, US Public Health Ser(cid:173)
`vice, Rockville, MD. Coauthor of Chapter 41, Parenteral
`Preparations.
`Eric J Lien, PhD / Professor of Pharmacy/Pharmaceutics and
`Biomedical Chemistry, School of Pharmacy, University of
`Southern California. Author of Chapter 13, Molecular Struc(cid:173)
`ture, Properities, and States of Matter.
`Hetty A Lima, RPh, FASHP / Regional Vice President, Corem
`Health Care. Coauthor of Chapter 119, Aseptic Technology
`for Home-Care Pharmaceuticals.
`Sylvia H Liu, BVM, DACVP / Vice President, Research and
`Development, Ethicon, Inc. Coauthor of Chapter 108, Surgi(cid:173)
`cal Supplies.
`Robert L McCarthy, PhD / Associate Professor of Pharmacy
`Adminis'tration, Massachusetts College of Pharmacy and Al(cid:173)
`lied Health Sciences. Coauthor of Chapter 3, Ethics and
`Professionalism.
`Michael R McConnell, RPh / Founder and Consultant, Na(cid:173)
`tional Notification Center. Author of Chapter 95, Product
`Recalls and Withdrawals.
`Randal P McDonough, PhD / Associate Professor (Clinical),
`College of Pharmacy, University of Iowa. Coauthor of Chap(cid:173)
`ter 92, Mark.eting Pharmaceutical Care Services.
`William F McGhan, PharmD, PhD / Professor of Pharmacy,
`Department of Pharmacy Practice and Pharmacy Admin(cid:173)
`istration, Philadelphia College of Pharmacy, University
`of the Sciences in Philadelphia. Author of Chapter 91,
`•
`Pharmacoeconomics.
`Barbara T McKinnon, PharmD / Director of Business Devel(cid:173)
`opment. NOVA FACTOR. Coauthor of Chapter 119, Aseptic
`Technology for Home-Care Pharmaceuticals.
`Karen B Main, PhD / Associate Manager, Director of Product
`Development, Pharmaceutical and Analytical R&D, Astra(cid:173)
`Zeneca, Wilmington, DE. Coauthor of Chapter 30,Analysis of
`. Medicinals.
`Henry J Malinowski, PhD/ Associate Director for Biopharma(cid:173)
`ceuticals, Division of Pharmaceutical Evaluation, Food and
`Drug Administration, Rockville, MD. Author of Chapter 53,
`Bioavailability and Bioequiualence Testing.
`Anthony S Manoguerra, PharmD / Professor of Clinical Phar(cid:173)
`macy, School of Pharmacy, University of California, San
`Francisco, San Diego Program; Director, San Diego Divisio~,
`California Poison Control System; University of California
`San Diego Medical Center. Coauthor of Chapter 99, Poison
`Control.
`Duane D Miller, PhD / Van Vleet ·professor, Department of
`Pharmaceutical Sciences, College of Pharmacy, The Univer(cid:173)
`sity of Tennessee. Author of Chapter 28, Structure-Activity
`Relationship and Drug Design.
`
`Michael Montagne, PhD / Rumbolt Professor of .Pharmacy,
`Division of Pharmaceutical Sciences, Massachusetts College
`of Pharmacy and Allied Health Sciences. Coauthor of Chap(cid:173)
`ter 3, Ethics and Professionalism, and Author of Chapter 96,
`Dru& Education.
`Nasccm Muhammad, P,hD / Director, Technical Services/ Beta
`Lactam and Oncology, Bristol-Myers Squibb. Coauthor of
`Chapter 34, Instrumental Methods of Analysis, and Chapter
`35, Dissolution.
`Michael D Murray, Pharm.D, MPH / Professor of Pharmacy,
`Purdue Pharmacy Program at Indianapolis, Purdue Univer(cid:173)
`sity. Author of Chapter 116, Pharmacoepidemiology.
`J G Nairn, PhD / Professor Emeritus, Faculty of Pharmacy,
`University of Toronto. Author of Chapter 39, Solutions,
`Emulsions, Suspensions, and Extracts.
`Gail D Newton, PhD / Associate Professor of Pharmacy Practice,
`School of Pharmacy and Pharmacal Sciences, Purdue Univer(cid:173)
`sity. Author of Chapter 110, Ambulatory Patumt Care.
`William K Nichols, PhD / Associate Professor of Pharmacology
`and Toxicology, College of Pharmacy, University of Utah.
`Author of Chapter 69, Respiratory Drugs, Chapter 77, Hor(cid:173)
`mones, and Chapter 87, Anti-lnfectives.
`Paul J Niebergall, PhD /Professor of Pharmaceutical Sciences,
`Medical University of South Carolina. Author of Chapter 17,
`Ionic Solutions and Electrolytic Equilibria.
`Jeffrey P Norenberg, PhD/ Assistant Professor of Pharmacy
`Practice, College of Pharmacy, University of New Mexico
`Health Sciences Center. Coauthor of Chapter 29, Fundamen(cid:173)
`tals of Medical Radionuclides.
`Rol;>ert E O'Connor, PhD / Adjunct Professor of Pharmaceutics,
`Philadelphia College of Pharmacy, University of the Sciences in
`Philadelphia. Coauthor of Chapter 37, Powders.
`Fred G Paavola, RPh / Rear Admiral, Office of the Chief Phar(cid:173)
`macist, United States Public Health Service, Rockville, MD.
`Coauthor of Chapter 7, Pharmacists and Public Health.
`Garnet E Peck, PhD/ Professor of Industrial Pharmacy, Direc(cid:173)
`tor of the Industrial Pharmacy Laboratory, School of Phar(cid:173)
`macy and Pharmacal Sciences, Purdue University. Author of
`Chapter 36, Separation.
`•
`Christopher J Perigard, BS, MT (ASCP), MBA/ Department of
`Pathology, Pharmaceutical Research Institute, Bristol-Myers
`Squibb Company, Syracuse, NY. Author of Chapter 32, Clinical
`Analysis.
`Lynn K Pershing, PhD / Research Associate Professor of Der(cid:173)
`matology, School of Medicine, University of Utah. Coauthor
`of Chapter 65, Topical Drugs.
`Elizabeth S Pithan, PharmD / Community Pharmaceutical
`Care Resident, University of Iowa. Coauthor of Chapter 92,
`Marketing Pharmaceutical Care Services.
`James A Ponto, MS/ Chief Nuclear Pharmacist and Clinical
`Professor, Division of Nuclear Medicine, University of Iowa
`Hospitals and Clinics and College of Pharmacy. Coauthor of
`Chapter 104, Nuclear Pharmacy Practice.
`Cathy Y Poon, PharmD / Assistant Professor of Clinical Phar(cid:173)
`macy, Philadelphia ColJege of Pharmacy, University of the
`Sciences in Philadelphia. Coauthor Chapter 18, Tonicity, Os(cid:173)
`moticity, Osmolality, and Osmolarity.
`Stuart C Porter, PhD/ President, PPT, Hatfield, PA. Author of
`Chapter 46, Coating of Pharmaceutical Dosage Forms.
`W Steven Pray, PhD/ Professor of Nonprescription Products
`and Devices, School of Pharmacy, Southwestern Oklahoma
`State University. Coauthor of Chapter 101, Self-Care and
`.
`Home Diagnostic Products.
`Barrett E Rabinow, PhD/ Director, Strategic Technical Devel(cid:173)
`opment, Baxter Healthcare Corporation, Round Lake, IL.
`Coauthor of Chapter 54, Plastic Packaging Materials.
`Galen W Radebaugh, PhD / Vice President, Analytical Devel(cid:173)
`opment, Schering-Plough Research Institute, Kenilworth,
`NJ. Coauthor of Chapter 38, Preformulation.
`Paul L Ranelli, PhD/ Associate Professor of Social and Behav(cid:173)
`ioral Pharmacy, School of Pharmacy, University of Wyoming.
`Author of Chapter 114, Patient Communication.
`Irwin Reich, BSc / Instructor and Manager Pharmacy Labora(cid:173)
`tory, Philadelphia College of Pharmacy, University of the
`Sciences in Philadelphia. Coauthor of Chapter 11, Phann'
`ceutical Calculations, and Chapter 18, Tonicity, Osmot'
`Osmolality, and Osmolarity.
`
`ix
`
`MPI EXHIBIT 1069 PAGE 8
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1069-0008
`
`

`

`r William J Reilly, Jr, BS (Pharm) / Director, .Manufacturing,
`
`ViroPharma. Jnc .. F.xton. PA. Author of Chapt.-.r 55. Phr,r(cid:173)
`mac:cuti<·al N,xcssitics.
`Joseph E Rice, PhD / Associate Pr01esi.or of :,iedicinal Chtm(cid:173)
`istry. Rutgers University College of Pharmacy. Coauthor of
`Chapter 25, Organic Pharmaceutical Chemistry. •
`June E Riedlinger, PharmD / Assistant Professor, Massachu(cid:173)
`setts College of Pharmacy and Allied Health Sciences. Co(cid:173)
`author of Chapter 103, Complementary and Al-ternative Med(cid:173)
`ietd Heal.th Care.
`Marian K Rippy, DVM, PhD, DACVD / Senior Principal Vet-.
`erinary Pathologist, Guidant Corporation. Coauthor of Chap(cid:173)
`ter 108, Surgical Supplies.
`Jaek Bobbina, PhD / Consultant, Pharmacy Affairs, Schering
`Laboratories. Author of Chapter 5, Pharmacists in Industry.
`Joseph R l(obin&on, PhD/ Professor of Pharmacy and Ophthal(cid:173)
`mology, School of Pharmacy, University ofWisconsin. Coauthor
`of Chapter 47, Controlled-Release Drug-Delivery Systems.
`Mark G Robson, PhD, MPH/ Executive Director, Environmen(cid:173)
`tal and Occupational Sciences Institute. Coauthor of Chapter
`107, Pesticides.
`Douglas E Rollins, MD, PhD / Professor, Pharmacology and
`Toxicology, College of Pharmacy, University of Utah. Author
`of Chapter 59, Clinical Pharmacokinetics, and Chapter 61,
`Aduerse Drug Reactions.
`Theodore J Roseman, PhD I Vice President, Scientific Affairs,
`Baxter Healthcare Corporation, Round Lake, IL. Coauthor.of
`Chapter 54, Plastic Packaging Materials.
`Joseph T Rubino, PhD / Section Head, Chemical Biological
`Pharmaceutical Development, Wyeth-Ayerst Research. Co(cid:173)
`author of Chapter 22, Coarse Dispersions.
`Orapin P Rubino, PhD/ Process Development Scientist, Glatt Air
`Techniques, Inc. Coauthor of Chapter 2:2, Coarse Dispersions.
`Edward M Rudnic, PhD / Vice President, Pharmaceutical
`Reasearch and Development, Pharmavene, Inc., Gaithers(cid:173)
`burg, MD. Coauthor of Chapter 92, Oral Solid Do.sage For·ms.
`Michael T Rupp, PhD/ Professor of Pharmacy Administration,
`Midwestern University-Glendale, Author of Chapter 93,
`Documenting and Billing for Pharmaceutical Care Services.
`Hans Schott, PhD / Professor Emeritus of Pharmaceutics and
`Colloid Chemistry, School of Pharmacy, Temple University.
`Author of Chapter 21, Collodial Dispersions, and Chapter 23,
`Rheology.
`Christopher J Sciarra, PhD, MSc / Vice President, Sciarra
`Laboratories, Inc, Hicksville, NY. Coauthor of Chapter 50,
`Aerosols.
`John J Sciarra, PhD / Professor Emeritus and President,
`Sciarra Laboratories, Inc, Hicksville, NY. Coauthor of Chap(cid:173)
`ter 50, Aerosols.
`Bruce E Scott, MS / Vice President, United Hospital-Allina
`Health System. Coauthor of Chapter 111, lnstitutio1wl Pa(cid:173)
`tient Care.
`Steven A Scott, PharmD / Associate Professor of Clinical Phar(cid:173)
`macy, Purdue University. Author of Chapter 97, The Prescrip(cid:173)
`tion, and Coauthor of Chapter 111, Institutional Patient Care.
`Stanley M Shaw, PhD/ Professor and Head, Division of Nuclear
`Pharmacy, School of Pharmacy and Pharmacal Science, Purdue
`University. Coauthor Chapter 104, Nuclear Pharmacy Practice.
`E Richard Shough, PhD / Professor of Medicinal Chemistry,
`College of Pharmacy, The University of Oklahoma. Author of
`Chapter 89, Immunizing Agents and Allergenic Extracts.
`Thomas C Snader, PharmD / Consultant Pharmacist. Author
`of Chapter 112, Long-Term Care Facilities.
`Gail G Snitkoff, PhD / Associate Professor, Division of Basic
`and Pharmaceutical Sciences, Albany College of Pharmacy.
`Author Chapter 31, Biological Testing.
`Theodore D Sokolski, PhD / Professor Emeritus, Ohio State
`University, Coauthor of Chapter 16, Solutions and Phase
`Equilibria.
`Patricia K Sonsalla, PhD/ Associate Professor of Neurology,
`University of Medicine and Dentistry of New Jersey-Robert
`Wood Johnson Medical School. Author of Chapter 85, Gen(cid:173)
`• •
`eral Nervous System Stimulants.
`Edwin T Sugita, PhD/ Professor and Chairman, Pharmaceutics
`Department, Philadelphia College of Pharmacy, University
`of the Sciences in Philadelphia. Coallthor of Chapttr 11,
`Pharmaceutical Calculations, and Chapter 18, Tonicity, Os(cid:173)
`moticity, Osmolality, and Osmolarity.
`
`Bonnie L Svarstad, PhD / William S Apple Professor of Social
`and Administrative Pharmacy. School of Pharmacy, Univer•
`sity of Wisconsin-Madison. Coauthor of ( :ha1>t.er I 1:~. Tire
`1~atumt: Behavioral Determitumts.
`Craig K Svensson,, PharmD, PhD/ Professor, Department of
`Pharmaceutical Sciences, College of Pharmacy and Allied
`Health Professions, Wayne State Univen;ity. Coauthor of
`Chapter 58, Basic Phannacokinetics.
`James Swarbriek, PhD / Vice President for Research and De(cid:173)
`velopment, Applied Analytical Industries, Inc. Coauthor of
`Chapter 22, Coarse Duipersions.
`Anthon7 R Temple, MD/ Executive Director, Medical Affairs,
`McNeil Consumer Products Co; Adjunct Associate Professor,
`Department of Pediatrics, University of Pennsylvania School
`of Medicine; Lecturer, Philadelphia College of Pharmacy.
`Coauthor of Chapter 99, Poison Control.
`Joseph Thomas m, PhD / Associate Professor of Pharmacy
`Administration, School of Pharmacy and Pharmacal Sci(cid:173)
`ences, Purdue University. Author of Chapter 94, Community
`Pharmacy Economics and Management.
`John P Tischio, PhD / Independent Consultant, Pharmaceuti(cid:173)
`cal Consulting Services, Manasquan, NJ. Author of Chapter
`62, Pharmacogenetics.
`Keith G Tolman, MD/ Professor, Division of Gastroenterology,
`School of Medicine, University of Utah. Coauthor of Chapter
`56, Diseases: Manifestations and Pathophysiology and Chap(cid:173)
`ter 66, Gastrointestinal and Liver Drugs.
`Salvatore J Turco, PharmD, F ASHP / Professor of Pharmacy,
`Temple University School of ~harmacy. Author of Chapter
`42, Intravenous Admixtures.
`Elizabeth B Vadas / Senior Director, Pharmaceutical Research
`and Development, Merck Frosst Canada, Inc°, Po