throbber

`
`
`
`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
`
`MPI EXHIBIT 1069 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 1 of 62
`
`

`

`=os
`pywv
`rnWwvya
`
`2 OrH EDITION
`
`
`Remington: The >
`Science and
`Practice
`of Pharmacy
`
`Volume I!
`
`ALFONSO R GENNARO
`
`Chairman of the Editorial Board
`
`and Editor
`
`INTERNATIONAL STUDENTEDITION
`
`an LIPPINCOTT WILLIAMS & WILKINS
`
`A Wolters Kluwer Company
`Philadelphia - Baltimore + New York + London
`Buenos Aires + Hong Kong - Sydney + Tokyo
`
`MPI EXHIBIT 1069 PAGE 2
`
`MPI EXHIBIT 1069 PAGE 2
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 2 of 62
`
`

`

`
`
`Editor: Daniel Limmer
`Managing Editor: Matthew J. Hauber
`Marketing Manager: Anne Smith
`
`Lippincott Williams & Wilkins
`
`351 West CamdenStreet
`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 contained 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 packageinserts 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-
`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 0-7817-200X-4
`
`The publishers have madeevery 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
`Namesis by permission of The USP Convention. The Convention is not respon-
`stble for any inaccuracy contained herein.
`Notice—Thistext is not intended to represent, nor shallit be interpretedto 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 andlabeling 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
`
`
`
`MPI EXHIBIT 1069 PAGE 3
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 3 of 62
`
`

`

`. A freotise on the rheory
`Remington: The Science and Practice of Pharmacy. .
`and practice of the pharmaceutical sciences, with essential
`information about pharmaceutical and medicinal agenrs; also, q
`guide to the professional responsibilities of the pharmacist as the
`drug information specialist of the health team... A textbook and
`_ feference work for pharmacists, physicians, and other practitioners of
`the pharmaceutical and medical sciences.
`
`EDITORS
`
`Alfonso R Gennaro, Chair
`
`—
`
`Nicholas G Popovich
`
`Ara H Der Marderosian
`
`Gien R Hanson
`
`Thomas Medwick
`
`Roger L Schnaare
`
`Joseph B Schwartz
`
`H Steve White
`
`AUTHORS
`
`The 119 chapters of this edition of Remingron were written by the
`editors, by members of the Editorial Board, and by the authors
`
`listed On pagesviii to x.
`
`Managing Editor
`
`Editorial Assistant
`
`John E Hoover, BSc (Pharm)
`Bonnie Brigham Packer, RNC, BA
`
`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
`
`MPI EXHIBIT 1069 PAGE 4
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 4 of 62
`
`

`

`Remington Historical/Biographical Data
`
`The following is a record of the editors and the dates of publication of successive editions of this book, prior ro the 13th
`Edirion known as Remingron’s Practice of Pharmacy and subsequently as Remington’s Pharmoceutical Sciences
`through the 19th Edition.
`
`Joseph P Remington
`
`Fifteenth Edition, 1975
`
`First Edition, 1866
`Second Edition, 1689
`Third Edition, 1897
`Fourth Edition, 1905
`Fifth Edition, 1907
`Sixth Edition, 1917
`
`Seventh Edition, 1926
`Editors
`E Fullerron Cook
`Charles H LaWoll
`
`Eighth Edition, 1996
`Editors
`E Fullerton Cook
`Charles H LaWall
`
`Ninth Edition, 1948
`Tenth Edition, 1954
`
`Joseph P Remington
`Assisted by
`E Fullerron Cook
`
`Associate Editors
`Ivor Griffith
`
`Adijey B Nichois
`Arthur Osol
`
`Editors
`E Fullerton Cook
`Eric \V Martin
`
`Chairman, Editorial Board
`Arthur Osol
`Edirors
`John T Anderson
`Cecil L Bendush
`Grafton D Chase
`Alfonso R, Gennaro
`Melvin R Gibson
`Sixteenth Edition, 1980
`Chairman, Editorial Board
`Arthur Osol
`Edirors
`Grafton D Chase
`Alfonso R Gennaro
`Melvin R Gibson
`
`Seventeenth Edition, 1985
`
`Managing Editor
`John E Hoover
`
`C Boyd Granberg
`Stewart C Harvey
`Robert E King
`Alfred N Martin
`
`Ewort A. Swinyard
`
`C€ Boyd Granberg
`Stewart C Harvey
`Robert E King
`Alfred N Martin
`
`Ewart A Swinyard
`Gilbert L Zink
`
`Managing Ediror
`John E Hoover
`
`Chairman, Editorial Board
`Alfonso A Gennaro
`Editors
`Eleventh Edition, 1956
`Grafton D Chase
`Edward G Rippie
`Ara H Der Marderosian
`Editors
`Associate Editors
`Joseph D Schwarz
`Eric W Martin
`E Emerson Leuallen
`Stewart C Harvey
`Ewart A Swinyard
`Daniel A Hussar
`Arthur Osol
`Gilbert L Zink
`E Fullerton Cook
`Thomas Medwick
`LinwoodFTice
`‘,
`Clarence T Van Merer
`
`Eighteenth Edition, 1990
`
`Twelfth Edition, 1964
`Editors
`Eric \V Martin
`E Fullerton Cook
`Editors
`E Emerson Leuallen
`Authur Osoil
`Grafton D Chase.
`Edward G Rippie
`Ara H Der Marderosian
`LinwoodFTice
`Joseph D Schwartz
`Stewart C Harvey
`Clarence T Van Meter
`Ewart A Swinyard
`Daniel A Hussar
`Gilbert L Zink
`Thomas Medwick
`
`Assistant to the Editors
`John Hoover
`
`Chairman, Editorial Board
`Alfonso R Gennaro
`
`Managing Editor
`John E Hoover
`Editorial Assistant
`Bonnie Packer
`
`Thirteenth Edition, 1965
`
`Editor-in-Chief
`Eric W Martin
`Editors
`Grafton D Chase
`Herald R Cox
`Richard A Deno
`Alfonso R Gennaro
`Stewart C Harvey
`
`Fourteenth Edition, 1970
`
`Chairman, Editorial Board
`Arthur Osol
`Editors
`Grafton D Chase
`Richard A Deno
`Alfanso R Gennaro
`Melvin R Gibson
`Stewart C Harvey
`
`Managing Editor
`John E Hoover
`
`Robert E King
`£ Emerson Levalien
`Authur Osol
`Ewart A Swinyard
`Clarence T Van Meter
`
`Managing Editor
`- Jonn E Hoover
`
`-
`
`Robert E King
`Alfred N Martin
`~ Ewart A Swinyard
`Clarence T Van Meter
`
`vi
`
`Nineteenth Edition, 1995
`
`Chairman, Editorial Board
`Alfonso R Gennaro
`
`Editors)
`Grafton D Chase
`Ara H Der Marderosian
`Glen R Hanson
`Daniel A Hussar
`Thomas Medwick
`
`Managing Ediror
`John E Hoover
`Editorial Assistant
`Bonnie Packer
`
`Edward G Rippie
`Joseph D Schwarz
`H Steve Whire
`Gilbert L Zink
`
`MPI EXHIBIT 1069 PAGE 5
`
`MPI EXHIBIT 1069 PAGE 5
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 5 of 62
`
`

`

`Editorial Board Members and Editors
`
`Alfonso R Gennaro, PhD / University of the Sciences in Philadelphia—Professor of Chemistry. Chair, Editorial
`Boord and Editor. Coeditor of Pan 6, Pharmacodynamics, and Part 7, Pharmaceutical and
`Medicinal Agents. Coouthor of Chapter 25.
`
`Ara H Der Marderosian, PhD / University of the Sciences in Philadelphia—Professor of Pharmacognosy and
`Medicinal Chemistry, Scientific Director, Complementary and Alternative Medicine Institute. Editor
`of Part 1, Orientation. Coauthor of Chapters 7, 49, and 103.
`
`Glen R Hanson, DDS, PhD / College of Pharmacy and School of Medicine, University of Urah—Professor of
`Pharmacology and Toxicology. Coeditor of Port 6, Pharmacodynamics, and Part 7 Pharmaceutical
`and Medicinal Agents. Author of Chapters 75, 76, and 83..
`
`Thomas Medwick, PhD / Rutgers University College of Pharmacy—Professor Emeritus, Department of
`Pharmaceutical Chemistry. Editor of Parr 3, Pharmaceutical Chemistry, and Part 4, Pharmaceutical
`Testing, Analysis, and Control. Author of Chaprer 24. Coauthor of Chapter 30.
`
`Nicholas G Popovich, PhD / Purdue University, School of Pharmacy and Pharmacal Sciences—Professor of
`Pharmacy Practice. Editor of Par 8A, Pharmacy Administration, Part 8B, Fundamentals of
`Pharmacy Practice, and Part 8C, Patient Care. Coauthor of Chapter 101.
`Roger L Schnaare, PhD / Universiry of the Sciences in Philadelphia, Philadelphia College of Pharmacy—
`Professor of Pharmacy, Department of Pharmaceutics. Editor of Part 2, Pharmaceutics. Coauthor
`of Chaprer 11.
`
`Joseph B Schwartz, PhD / University of the Sciences in Philadelphia, Philadelphia College of Pharmacy.
`Burroughs-Wellcome Fund Professor of Pharmaceutics, Director of Pharmacy Research. Editor of
`Part 5, Pharmaceutical Manufacturing. Coauthor of Chapters 37 and 45.
`H Steve White, PhD / College of Pharmacy, University of Urah—Associate Professor of Pharmacology and
`Toxicology. Coeditor of Part 6, Pharmacodynamics, and Part 7, Pharmaceutical and Medicinal
`Agents. Author of Chapters 74, 79, 80, 81, 84, and 88.
`
`|
`
`MPI EXHIBIT 1069 PAGE 6
`
`MPI EXHIBIT 1069 PAGE 6
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 6 of 62
`
`

`

`Authors
`
`Marie A Abate, PharmD / Professor and Associate Chair of
`Joseph L Fink III, BSPharm, JD/ Assistant Vice President for
`Clinical Pharmacy, School of Pharmacy, West Virginia Uni-
`Research and Graduate Studies, Professor of Pharmacy, Col-
`lege of Pharmacy, University of Kentucky. Author Chapter1,
`versity. Coauthor of Chapter 9, Clinical Drug Literature.
`Hamed M Abdou, PhD / President, Worldwide Pharmaceutical
`Scope of Pharmacy, and Coauthor of Chapter 90, Laws Gov-
`Technical Operations, Bristol-Myers Squibb, Lawrenceville,
`erning Pharmacy.
`Annette E Fleckenstein, PhD / Assistant Professor of Pharma-
`NJ. Coauthor of Chapter 34, Instrumental Methods of Anal-
`ysis, and Chapter 35, Dissolution.
`cology and Toxicology, University of Utah. Author of Chapter
`Mignon S Adams/Director of Library and information Services,
`63, Pharmacological Aspects of Substance Abuse, and Chap-
`Joseph W England Library, University of the Sciences in
`ter 72, Adrenergic Antagonists and Adrenergie Neuron Block-
`Philadelphia. Coauthor Chapter 8, Information Resources in
`ing Drugs.
`Pharmacy and the Pharmaceutical Sciences.
`Michael R Franklin, PhD / Professor of Pharmacology, College
`Loyd V Allen, Jr, PhD / Professor Emeritus, Department of
`of Pharmacy and School of Medicine, University of Utah.
`Medicinal Chemistry and Pharmaceutics, College of Phar-
`Coauthor of Chapter 57, Drug Absorption, Action, and Dis-
`macy, University of Oklahoma. Author of Chapter 98, Extem-
`position, and Author of Chapter 105, Enzymes.
`poraneous Prescription Compounding.
`Donald N Franz, PhD / Professor of Pharmacology and Toxicol-
`Howard Y Ando, PhD/Director, Discovery Lead Optimization,
`ogy, School of Medicine, University of Utah. Coauthor of
`Pfizer Global R&D, Ann Arbor Laboratories, Pfizer, Inc, Ann
`Chapter 68, Cardiovascular Drugs, Chapter 71, Cholinomi-
`* Arbor, MI. Coauthor of Chapter 38, Preformutation.
`metic Drugs, and Chapter 73, Antimuscarinic and Antispas-
`Kenneth E Avis, DSc* / Emeritus Professor, Pharmaceutical Sci-
`modic Drugs.
`ences, College of Pharmacy, University ofTennessee, Memphis.
`Ruta Freimanis, PharmD, RPh / Secretary, United States
`Coauthor of Chapter 41, Parenteral Preparations, and Chapter
`Adopted Names Council, Chicago, IL. Author of Chapter 27,
`118, Aseptic Technology for Home-Care Pharmaceuticals.
`Drug Nomenclature—United States Adopted Names.
`Leonard C Bailey, PhD / Professor of Pharmaceutical Chemis-
`Raymond E Galinsky, PharmD / Professor, Department of
`try, Rutgers University College of Pharmacy. Author of
`Industrial and Physical Pharmacy, School of Pharmacy and
`Chapter 38, Chromatography.
`Pharmacal Sciences, Purdue University. Coauthor of Chap-
`Jan N Bair, PhD / Professor Emeritus of Hospital Pharmacy,
`ter 58, Basic Pharmacokinetics.
`College of Pharmacy, University of Utah. Author of Chapter
`Barry D Garfinkle, PhD / Vice President, Vaccine Technology
`64, Diagnostic Drugs and Reagents.
`and Engineering, Manufacturing Division, Merck & Co, Inc,
`Louis R Barrows, PhD / Professor of Pharmacy and Toxicology,
`_ West Point, PA. Coauthor of Chapter 40, Sterilization.
`College of Pharmacy, University of Utah. Author of Chapter
`Harold N Godwin, PhD / Professor and Director of Pharmacy,
`86, Antineoplastic and Immunoactive Drugs.
`The University of Kansas Medical Center. Author of Chapter
`Sara Beis, MS / Pharmacy Management Consultant. Coauthor of
`111, Institutional Patient Care.
`Chapter 117, Integrated Health-Care Delivery Systems.
`Lawrence H Biock, PhD / Professor of Pharmaceutics, Du-
`Martin C. Gregory, BM, BCh, DPhil / Professor, Division of
`General Internal Medicine, School of Medicine, University of
`quesne University School of Pharmacy. Author of Chapter
`44, Medicated Topicals.
`Utah. Coauthor of Chapter 56, Diseases: Manifestations and
`Sanford Bolton, PhD / Visiting Professor, Department of Phar-
`Pathophysiology.
`macy, University ofArizona. Author of Chapter 12, Statistics.
`Pardeep K Gupta, PhD / Associate Professor, Philadelphia
`Leslie Ann Bowman, BA / Coordinator of Instructional Ser-
`Collége of Pharmacy, University of the Sciences in Philadel-
`vices, Joseph W England Library, University of the Sciences
`phia. Author of Chapter 16, Solutions and Phase Equilibria.
`in Philadelphia. Coauthor Chapter 8, Information Rescurces
`Samir Hanna, PhD/Vice President (Retired), Worldwide Qual-
`in Pharmacy and the Pharmaceutical Sciences.
`ity Control and Bulk Quality Assurance, Bristol-Myers
`Dara C Bultman, PhD / Program Manager, Medical Media
`Squibb, Syracuse, NY. Coauthor of Chapter 34, Instrumental
`Associates, Inc. Coauthor of Chapter 113, The Patient: Be-
`Methods ofAnalysis, and Chapter 35, Dissolution.
`havioral Determinants.
`Gerald Hecht, PhD / Senior Director, Pharmaceutical Sciences,
`Paul M Bummer, PhD / Associate Professor of Pharmaceutical
`Alcon Laboratories, Fort Worth, TX. Authorof Chapter 43,
`Sciences, College of Pharmacy, University of Kentucky. Au-
`Ophthalmic Preparations.
`thor Chapter 20, Interfacial Phenomena.
`Martin W Henley, MSc / Coauthor of Chapter 40, Sterilization.
`Karleen S Callahan, PhD / Research Assistant Professor of Phar-
`Merk & Co, Inc, West Point, PA, (Retired)
`macology, College of Pharmacy, University of Utah. Coauthorof
`Daniel A Herbert, RPh, FACA/ President and CEO, Richmond
`Chapter 67, Blood, Fluids, Electrolytes, and Hematologic Drugs.
`Apothecaries, Inc. Coauthor Chapter 4, Community Phar-
`Patrick N Catania, PhD / Professor and Chairman, Department
`macy Practice.
`of Pharmacy Practice, School of Pharmacy, University of the
`Gregory J Higby, PhD / Director, American Institute of the
`Pacific. Author Chapter 118, Home Health Patient Care.
`History of Pharmacy, School of Pharmacy University of Wis-
`Amy Christopher/ Coordinator of Outreach Services, Joseph W
`consin. Author of Chapter 2, Evolution of Pharmacy.
`England Library, University of the Sciences in Philadelphia.
`James R Hildebrand II, PharmD / Target Research Associ-
`Coauthor Chapter 8, Information Resources in Pharmacy
`ates, Philadelphia. Coauthor of Chapter 9, Clinical Drug
`and the Pharmaceutical Sciences.
`Literature.
`Kenneth A Connors, PhD / Professor Emeritus of Pharmaceu-
`William B Hladik WI, MS / Associate Professor, College of
`tics, School of Pharmacy, University of Wisconsin. Author of
`Pharmacy, University of New Mexico Health Sciences Cen-
`Chapter 14, Complex Formation.
`ter. Coauthor of Chapter 29, Fundamentals of Medical
`Clarence A Discher, PhD* / Professor Emeritus, Rutgers
`Radionuctides.
`University.
`Daniel A Hussar, PhD / Remington Professor of Pharmacy,
`William R Doucette, PhD / Associate Professor, College of
`Philadelphia College of Pharmacy, University of the Sciences
`Pharmacy, University of lowa. Coauthor of Chapter 92, Mar-
`in Philadelphia. Author of Chapter 102, Drug Interactions,
`keting Pharmaceutical Care Services,
`and Chapter 115, Patient Compliance.
`Victoria E Doyle, CIH, MPH / Environmental and Occupa-
`tional Health Sciences Institute UMD School of Public
`Timothy J Ives, PharmD, MPH / Associate Professor of Phar-
`Health. Coauthor Chapter 107, Pesticides.
`macy and Clinical Associate Professor of Family Medicine,
`John E Enders, PhD, MBA / Director of Quality Assurance,
`University of North Carolina. Coauthor of Chapter 7, Phar-
`macists and Public Health.
`Delmont Laboratories, Swarthmore, PA. Author of Chapter
`51, Quality Assurance and Control.
`Joel O Johnson, MD PhD / Associate Professor of Clinical
`Anesthesiology, and Neurosurgery, School of Medicine, Uni-
`versity of Missouri—Columbia. Author Chapter 78, General
`Anesthetics.
`
`*Deceased.
`
`MPI EXHIBIT 1069 PAGE 7
`
`MPI EXHIBIT 1069 PAGE 7
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 7 of 62
`
`

`

`Russell Katz, MD / Deputy Director, Division of Neuropharma-
`Michael Montagne, PhD / Rumbolt Professor of Pharmacy,
`Division of Pharmaceutical Sciences, Massachusetts College
`cological Drug Products, Center for Drug Evaluation and
`Research, Food and Drug Administration, Rockville, MD.
`of Pharmacy and Allied Health Sciences. Coauthor of Chap-
`Author of Chapter 48, The Introduction of New Drugs.
`ter 3, Ethics and Professionalism, and Authorof Chapter 96,
`Kristin A Keefe, PhD / Assistant Professor, Department of
`Drug Education.
`Naseem Muhammad, PhD/Director, Technical Services / Beta
`Pharmacology and Toxicology, College of Pharmacy, Univer-
`Lactam and Oncology, Bristol-Myers Squibb. Coauthor of
`sity of Utah. Author of Chapter 70, Sympathomimetic Drugs.
`Calvin H Knowlton, RPh, MDiv, PhD, FACA / CEO, Hospice
`Chapter 34, Instrumental Methods ofAnalysis, and Chapter
`35, Dissolution.
`Pharmacia, Inc. Coauthor of Chapter 4, The Practice of Com-
`Michael D Murray, PharmD, MPH / Professor of Pharmacy,
`munity Pharmacy.
`Richard W Knueppel, RPh / President, Knueppel Health Care
`Purdue Pharmacy Program at Indianapolis, Purdue Univer-
`Services, Inc. Author of Chapter 9, Health Accessories.
`sity. Author of Chapter 116, Pharmacoepidemiology.
`Kristine Knutson, PhD/Associate Professor of Pharmaceutics,
`J G Nairn, PhD / Professor Emeritus, Faculty of Pharmacy,
`College of Pharmacy, University of Utah. Coauthor of Chap-
`University of Toronto. Auther of Chapter 39, Solutions,
`ter 65, Topical Drugs.
`Emutsions, Suspensions, and Extracts.
`Allen M Kratz, PharmD / President, HVS Laboratories, Inc.
`Gail D Newton, PhD / Associate Professor of Pharmacy Practice,
`Coauthor of Chapter 103, Complementary and Alternative
`School of Pharmacy and Pharmacal Sciences, Purdue Univer-
`Medical Health Care.
`sity. Author of Chapter 110, Ambulatory Patient Care.
`David J Kroll, PhD / Associate Professor of Pharmacology and
`William K Nichols, PhD / Associate Professor of Pharmacology
`Toxicology, Center for Pharmaceutical Biotechnology, Uni-
`and Toxicology, College of Pharmacy, University of Utah.
`versity of Colorado School of Pharmacy. Coauthorof Chapter
`Author of Chapter 69, Respiratory Drugs, Chapter 77, Hor-
`49, Biotechnology and Drugs.
`mones, and Chapter 87, Anti-Infectives.
`Arthur J Lawrence, PhD / Rear Admiral, Assistant Surgeon
`Paul J Niebergall, PhD /Professor of Pharmaceutical Sciences,
`General, Office of the Assistant Secretary for Health and
`Medica] University of South Carolina. Author of Chapter 17,
`Surgeon General. Author of Chapter 6, Pharmacists in
`fonic Solutions and Electrolytic Equilibria.
`Government.
`Jeffrey P Norenberg, PhD / Assistant Professor of Pharmacy
`Thomas Wai-Yip Lee, BPharm / Research Assistant, Schooi of
`Practice, College of Pharmacy, University of New Mexico
`Pharmacy, University of Wisconsin. Assistant on Chapter 47,
`Health Sciences Center. Coauthor of Chapter 29, Fundamen-
`Controlled-Release Drug-Delivery Systems.
`tals of Medical Radionuclides.
`John W Levchuk, PhD / Captain, US Public Health Ser-
`Robert E O’Connor, PhD / Adjunct Professor of Pharmaceutics,
`vice, Rockville, MD. Coauthor of Chapter 41, Parenteral
`Philadelphia College of Pharmacy, University of the Sciences in
`Preparations.
`.
`Philadelphia. Coauthor of Chapter 37, Powders.
`Eric J Lien, PhD / Professor of Pharmacy/Pharmaceutics and
`Fred G Paavola, RPh / Rear Admiral, Office of the Chief Phar-
`Biomedical Chemistry, School of Pharmacy, University of
`macist, United States Public Health Service, Rockville, MD.
`Southern California. Author of Chapter 13, Molecular Struc-
`Coauthor of Chapter 7, Pharmacists and Public Health.
`ture, Properities, and States of Matter.
`Garnet E Peck, PhD / Professor of Industrial Pharmacy, Direc-
`Hetty A Lima, RPh, FASHP / Regional Vice President, Corem
`tor of the Industrial Pharmacy Laboratory, School of Phar-
`Health Care. Coauthor of Chapter 119, Aseptic Technology
`macy and Pharmacal Sciences, Purdue University. Author of
`for Home-Care Pharmaceuticals.
`Chapter 36, Separation.
`:
`Sylvia H Liu, BVM, DACVP / Vice President, Research and
`Christopher J Perigard, BS, MT (ASCP), MBA/Departmentof
`Development, Ethicon, Inc. Coauthor of Chapter 108, Surgi-
`Pathology, Pharmaceutical Research. Institute, Bristol-Myers
`cal Supplies.
`Squibb Company, Syracuse, NY. Author of Chapter 32, Clinical
`Robert L McCarthy, PhD / Associate Professor of Pharmacy
`Analysis.
`Adininistration, Massachusetts College of Pharmacy and A!-
`Lynn K Pershing, PhD / Research Associate Professor of Der-
`lied Health Sciences. Coauthor of Chapter 3, Ethics and
`matology, School of Medicine, University of Utah. Coauthor
`Professionalism.
`of Chapter 65, Topical Drugs.
`Michael R McConnell, RPh / Founder and Consultant, Na-
`Elizabeth S Pithan, PharmD / Community Pharmaceutical
`tional Notification Center. Author of Chapter 95, Product
`Care Resident, University of Iowa. Coauthor of Chapter 92,
`Recalls and Withdrawals.
`Marketing Pharmaceutical Care Services.
`Randal P McDonough, PhD / Associate Professor (Clinical),
`James A Ponto, MS / Chief Nuclear Pharmacist and Clinical
`College of Pharmacy, University of Iowa. Coauthor of Chap-
`Professor, Division of Nuclear Medicine, University of Iowa
`ter 92, Marketing Pharmaceutical Care Services.
`Hospitals and Clinics and College of Pharmacy. Coauthor of
`William F McGhan, PharmD, PhD / Professor of Pharmacy,
`Chapter 104, Nuclear Pharmacy Practice.
`Department of Pharmacy Practice and Pharmacy Admin-
`Cathy Y Poon, PharmD / Assistant Professor of Clinical Phar-
`istration, Philadelphia College of Pharmacy, University
`macy, Philadelphia College of Pharmacy, University of the
`of the Sciences in Philadelphia. Author of Chapter 91,
`Pharmacoeconomics.
`Sciences in Philadelphia. Coauthor Chapter 18, Tonicity, Os-
`moticity, Osmolality, and Osmolarity.
`Barbara T McKinnon, PharmD/ Director of Business Devel-
`Stuart C Porter, PhD / President, PPT, Hatfield, PA. Author of
`opment. NOVA FACTOR. Coauthor of Chapter 119, Aseptic
`Chapter 46, Coating of Pharmaceutical Dosage Forms.
`Technology for Home-Care Pharmaceuticals.
`WSteven Pray, PhD / Professor of Nonprescription Products
`Karen B Main, PhD / Associate Manager, Director of Product
`and Devices, School of Pharmacy, Southwestern Oklahoma
`Development, Pharmaceutical and Analytical R&D, Astra-
`State University. Coauthor of Chapter 101, Self-Care and
`Zeneca, Wilmington, DE. Coauthor of Chapter 30, Analysis of
`. Medicinals.
`' Home Diagnostic Products.
`Barrett E Rabinow, PhD/Director, Strategic Technical Devel-
`Henry J Malinowski, PhD / Associate Director for Biopharma-
`opment, Baxter Healthcare Corporation, Round Lake, IL.
`ceuticals, Division of Pharmaceutical Evaluation, Food and
`Coauthor of Chapter 54, Plastic Packaging Materials.
`Drug Administration, Rockville, MD. Author of Chapter 53,
`Galen W Radebaugh, PhD / Vice President, Analytical Devel-
`Bioavailability and Bioequivalence Testing.
`opment, Schering-Plough Research Institute, Kenilworth,
`Anthony S Manoguerra, PharmD / Professor of Clinical Phar-
`NJ. Coauthor of Chapter 38, Preformulation.
`macy, School of Pharmacy, University of California, San
`Paul L Ranelti, PhD / Associate Professor of Social and Behav-
`Francisco, San Diego Program; Director, San Diego Division,
`ioral Pharmacy, School of Pharmacy, University of Wyoming.
`California Poison Control System; University of California
`Author of Chapter 114, Patient Communication.
`San Diego Medical Center. Coauthor of Chapter 99, Poison
`Control.
`Irwin Reich, BSc / instructor and Manager Pharmacy Labora-
`tory, Philadelphia College of Pharmacy, University of the
`Duane D Miller, PhD / Van Vleet Professor, Department of
`Sciences in Philadelphia. Coauthor of Chapter 11, Pharm~
`Pharmaceutical Sciences, College of Pharmacy, The Univer-
`ceutical Calculations, and Chapter 18, Tonicity, Osmot’
`sity of Tennessee. Author of Chapter 28, Structure—Activity
`Relationship and Drug Design.
`Osmolality, and Osmoilarity.
`
`MPI EXHIBIT 1069 PAGE 8
`
`MPI EXHIBIT 1069 PAGE 8
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1069, p. 8 of 62
`
`

`

` William J Reilly, Jr, BS (Pharm) / Director, Manufacturing,
`
`Bonnie L Svarstad, PhD / William S Apple Professor of Social
`ViroPharma, Inc.. Rxton. PA. Author of Chapter 55, Phar-
`and Administrative Pharmacy. School of Pharmacy, Univer-
`maceutical Necessities.
`sity of Wisconsin—Madison. Cuauther of Chapter 113, The
`Patient: Behavioral Determinants.
`Joseph E Rice, PhD / Associate Preiessor of sfedicinal Cheu-
`istry, Rutgers University College of Pharmacy. Coauthor of
`Craig K Svensson, PharmD, PhD / Professor, Department of
`Chapter 25, Organic Pharmaceutical Chemistry. '
`Pharmaceutical Sciences, College of Pharmacy and Allied
`June E Riedlinger, PharmD / Assistant Professor, Massachu-
`Health Professions, Wayne State University. Coauthor of
`setts College of Pharmacy and Allied Health Sciences. Co-
`Chapter 58, Basic Pharmacokinetics.
`James Swarbrick, PhD / Vice President for Research and De-
`author ofChapter 103, Complementary and Alternative Med-
`ical Health Care.
`velopment, Applied Analytical Industries, Inc. Coauthor of
`Marian K Rippy, DVM, PhD, DACVD / Senior Principal Vet-
`Chapter 22, Coarse Dispersions.
`erinary Pathologist, Guidant Corporation. Coauthor of Chap-
`Anthony R Temple, MD / Executive Director, Medical Affairs,
`ter 108, Surgical Supplies.
`McNeil Consumer Products Co; Adjunct Associate Professor,
`Jack Robbins, PhD / Consultant, Pharmacy Affairs, Schering
`Departmentof Pediatrics, University of Pennsylvania Schoo!
`Laboratories. Author of Chapter 5, Pharmacists in Industry.
`of Medicirie; Lecturer, Philadelphia College of Pharmacy.
`Joseph R Kobinson, PhD / Professor of Pharmacy and Ophthal-
`Coauthor of Chapter 99, Poison Control.
`mology, School ofPharmacy, University ofWisconsin. Coauthor
`Joseph Thomas II, PhD / Associate Professor of Pharmacy
`of Chapter 47, Controiled-Release Drug-Delivery Systems.
`Administration, School of Pharmacy and Pharmacal Sci-
`Mark G Robson, PhD, MPH / Exccutive Director, Environmen-
`ences, Purdue University. Author of Chapter 94, Community
`tal and Occupational Sciences Institute. Coauthor of Chapter.
`Pharmacy Economics and Management.
`107, Pesticides.
`John P Tischio, PhD / Independent Consultant, Pharmaceuti-
`Douglas E Roliins, MD, PhD / Professor, Pharmacology and
`cal Consulting Services, Manasquan, NJ. Author of Chapter
`Toxicology, College of Pharmacy, University of Utah. Author
`62, Pharmacogenetics.
`of Chapter 59, Clinical Pharmacokinetics, and Chapter 61,
`Keith G Tolman, MD/Professor, Division of Gastroenterclogy,
`Adverse Drug Reactions.
`School of Medicine, University of Utah. Coauthor of Chapter
`Theodore J Roseman, PhD / Vice President, Scientific Affairs,
`56, Diseases: Manifestations and Pathophysiology and Chap-
`Baxter Healthcare Corporation, Round Lake, IL. Coauthorof
`ter 66, Gastrointestinal and Liver Drugs.
`Chapter 54, Plastic Packaging Materials.
`Joseph T Rubino, PhD / Section Head, Chemical Biological
`Salvatore J Turco, PharmD, FASHP / Professor of Pharmacy,
`Pharmaceutical Development, Wyeth-Ayerst Research. Co-
`Temple University School of Pharmacy. Author of Chapter
`author of Chapter 22, Coarse Dispersions.
`42, Intravenous Admixtures,
`Orapin P Rubino, PhD / Process DevelopmentScientist, Glatt Air
`Elizabeth B Vadas/ Senior Director, Pharmaceutical Research
`Techniques, Inc. Coauthor of Chapter #2, Coarse Dispersions.
`and Development, Merck Frosst Canada, Iné¢, Point Claire,
`Edward M Rudnic, PhD / Vice President, Pharmaceutical
`Darval, Quebec. Author Chapter 52, Stability of Pharmaceu-
`tical Products.
`Reasearch and Development, Pharmavene, Inc., Gaithers-
`burg, MD. Coauthorof Chapter 92, Oral Solid Dosage Forms.
`Ernestine Vanderveen, PhD / National Institute on Alcohol
`Michael T Rupp, PhD/Professor of Pharmacy Administration,
`Abuse and Alcoholism, National Institutes of Health, Rock-
`Midwestern University—Glendale, Author of Chapter 93,
`ville, Maryland.
`Documenting and Billing for Pharmaceutical Care Services.
`John E Vandervenn, PhD / Center for Food Safety and
`Hans Schott, PhD / Professor Emeritus of Pharmaceutics and
`Applied Nutrition, Food and Drug Administration, Wash-
`Colloid Chemistry, Schcol of Pharmacy, Temple University.
`ington, DC.
`:
`Author of Chapter 21, Collodial Dispersions, and Chapter 23,
`Vincent S Venturella, PhD / Director, Pharmaceutical Con-
`Rheology.
`sulting, Ventura Associates, Wayne, NJ. Author of Chapter
`Christopher J Sciarra, PhD, MSc / Vice President, Sciarra
`26, Natural Products.
`Laboratories, Inc, Hicksville, NY. Coauthor of Chapter 50,
`Aerosols.
`Jesse C Vivian, PhD, JD / Professor of Pharmacy Law, De-
`partment of Pharmacy Practice, Wayne State University.
`Jehn J Sciarra, PhD / Professor Emeritus and President,
`Coauthor of Chapter 90, Laws Governing Pharmacy.
`Sciarra Laboratories, Inc, Hicksville, NY. Coauthor of Chap-
`Lane J Wallace, PhD / Professor of Pharmacology, College of
`ter 50, Aerosols.
`Bruce E Scott, MS/ Vice President, United Hospital-—-Allina
`Pharmacy, The Ohio State University. Author of Chapter 82,
`Psychopharmacologic Agents.
`Health System, Coauthor of Chapter 111, Institutional Pa-
`tient Care.
`Maria L Webb, PhD / Director, Biology, Pharmacopeia, Prince-
`Steven A Scott, PharmD / Associate Professor of Clinical Phar-
`ton, NJ. Author of Chapter 10, Research.
`Donna S West, PhD, FACA / University of Mississippi. Coau-
`macy, Purdue University. Author of Chapter 97, The Prescrip-
`tion, and Coauthor of Chapter 111, Institutional Patient Care.
`thor of Chapter 4, The Practice of Community Pharmacy.
`Stanley M Shaw, PhD / Professor and Head, Division of Nuclear
`Timothy S Wiedmann, PhD / Assistant Professor, College of
`Pharmacy, School of Pharmacy and Pharmacal Science, Purdue
`Pharmacy, University of Minnesota. Author of Chapter 15,
`University. Coauthor Chapter 104, Nuclear Pharmacy Practice.
`Thermodynamics.
`:
`E Richard Shough, PhD / Professor of Medicinal Chemistry,
`Rodney J Wigent, PhD / Associate Professor of Chemistry,
`College of Pharmacy, The University of Oklahoma. Author of
`Research Associate, Professor of Pharmaceutics, University
`Chapter 89, Immunizing Agents and Allergenic Extracts.
`of the Sciences in Philadelphia. Author of Chapter 19, Chem-
`Thomas C Snader, PharmD / Consultant Pharmacist. Auther
`ical Kinetics.
`of Chapter 112, Long-Term Care Facilities.
`Olivia B Wood, RD, MPh / Associate Professor of Foods and
`Gail G Snitkoff, PhD / Associate Professor, Division of Basic
`Nutrition, School of Consumer and Family Sciences, Purdue
`and Pharmaceutical Sciences, Albany College of Pharmacy.
`University. Author of Chapter 100, Nutrition in Pharmacy
`Author Chapter 31, Biological Testing.
`Practice.
`Theodore D Sokolski, PhD / Professor Emeritus, Ohio State
`Alisa Wright, BS, MS / Business Affairs Manager, Cook Phar-
`University, Coauthor of Chapter 16, Solutions and Phase
`maceutical Solutions. Coauthor of Chapter 95, Product Re-
`Equilibria.
`calls and Withdrawals.
`Patricia K Sonsalla, PhD / Associate Professor of Neurology,
`Barba

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket