New Drug Approval Process, Fourth 4Ed, Accelerating Global ...

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New Drug Approval ProcessFourth EditionAccelerating Global Registrationsedited byRichard A.Guarino, M.D.Oxford Pharmaceutical Resources, Inc.Totowa, New Jersey, U.S.A.MARCEL DEKKER, INC.NEW YORK • BASEL
To purchase your own copy of this or any of Taylor & Francis or Routledge’s collection ofthousands of eBooks please go to http://www.ebookstore.tandf.co.uk/.The third edition was published as New Drug Approval Process: Third Edition, The GlobalChallenge.Although great care has been taken to provide accurate and current information, neither theauthor(s) nor the publisher, nor anyone else associated with this publication, shall be liable for anyloss, damage, or liability directly or indirectly caused or alleged to be caused by this book. Thematerial contained herein is not intended to provide specific advice or recommendations for anyspecific situation.Trademark notice: Product or corporate names may be trademarks or registered trademarks and areused only for identification and explanation without intent to infringe.Library of Congress Cataloging-in-Publication Data A catalog record for this book is availablefrom the Library of Congress.ISBN 0-203-02162-2 Master e-book ISBNISBN: 0-8247-5041-1 (Print Edition)Headquarters Marcel Dekker, Inc., 270 Madison Avenue, New York, NY 10016, U.S.A. tel:212–696–9000; fax: 212–685–4540This edition published in the Taylor & Francis e-Library, 2005.Distribution and Customer Service Marcel Dekker, Inc., Cimarron Road, Monticello, New York12701, U.S.A. tel: 800–228–1160; fax: 845–796–1772Eastern Hemisphere Distribution Marcel Dekker AG, Hutgasse 4, Postfach 812, CH-4001 Basel,Switzerland tel: 41–61–260–6300; fax: 41–61–260–6333World Wide Web http://www.dekker.com/The publisher offers discounts on this book when ordered in bulk quantities. For more information,write to Special Sales/Professional Marketing at the headquarters address above.Copyright © 2004 by Marcel Dekker, Inc.All Rights Reserved.Neither this book nor any part may be reproduced or transmitted in any form or by any means,electronic or mechanical, including photocopying, microfilming, and recording, or by anyinformation storage and retrieval system, without permission in writing from the publisher.
Page 4 and 5: Harry G.BrittainCenter for Pharmace
Page 6 and 7: 15. Pharmacokinetics: Second Editio
Page 8 and 9: 51. Managing the Clinical Drug Deve
Page 10 and 11: 87. Drug Products for Clinical Tria
Page 12 and 13: 122. Surfactants and Polymers in Dr
Page 16: To the victims of the tragic events
Page 19 and 20: sponsors’, investigators’, and
Page 21 and 22: Personnel involved in new product d
Page 23 and 24: 12. Biostatistics in Pharmaceutical
Page 25: ContributorsPatricia Blaine, R.R.T.
Page 28 and 29: New drug approval process 2II. DRUG
Page 30 and 31: New drug approval process 4drug dev
Page 32 and 33: New drug approval process 6IV. CLIN
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Page 36 and 37: New drug approval process 104. Cond
Page 38 and 39: New drug approval process 12H. Qual
Page 40 and 41: New drug approval process 14VI. Man
Page 42 and 43: 2Nonclinical Drug Development:Pharm
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Page 48 and 49: New drug approval process 22Figure
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New drug approval process 382. Geno
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New drug approval process 40prior t
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New drug approval process 42Table 3
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New drug approval process 44VI. NON
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New drug approval process 46metabol
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New drug approval process 48require
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New drug approval process 507. Huma
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New drug approval process 5216. ICH
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Investigational new drug applicatio
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4General Considerations of the New
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General considerations of the new d
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5The New Drug Application, Content
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New drug application, content and f
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6Abbreviated and Supplemental New D
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Abbreviated and supplemental new dr
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7The Biologic License Application (
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The biologic license application 16
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8Device Legislation and Application
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Device legislation and application
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9Orphan DrugsJohn T.ZennoRegulatory
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Orphan drugs 209Once the OOPD deter
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Orphan drugs 211section 507 [Ed. no
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Orphan drugs 213approval letter fro
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Orphan drugs 215first drug is requi
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Orphan drugs 217designated by the F
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Orphan drugs 219Once an orphan desi
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Orphan drugs 221REFERENCES1. Haffne
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New drug approval process 224resear
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New drug approval process 226to be
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New drug approval process 228Blindn
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New drug approval process 230Sponso
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New drug approval process 232precli
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New drug approval process 234commen
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New drug approval process 236opened
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New drug approval process 238event
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New drug approval process 240“Adv
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New drug approval process 24225. Mo
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New drug approval process 244Althou
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New drug approval process 24632. Wi
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Adverse reactions, and interaction
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New drug approval process 270decisi
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New drug approval process 272uncert
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New drug approval process 274Althou
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New drug approval process 276On the
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New drug approval process 278charac
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New drug approval process 280perspe
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New drug approval process 282Fortun
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New drug approval process 284graphi
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New drug approval process 286ACKNOW
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New drug approval process 288A. Ins
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New drug approval process 290CFSAN
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New drug approval process 292• Va
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New drug approval process 294The dr
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New drug approval process 296the me
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New drug approval process 298develo
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New drug approval process 300review
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New drug approval process 302Psycho
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New drug approval process 304draft)
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New drug approval process 306reques
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14Chemistry, Manufacturing, and Con
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Requirements of the NDA and AN DA 3
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New drug approval process 346II. TE
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New drug approval process 348Vary s
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New drug approval process 350consid
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Preparing for FDA Inspections 353In
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Preparing for FDA Inspections 3555.
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Preparing for FDA Inspections 357F.
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Preparing for FDA Inspections 359J.
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Preparing for FDA Inspections 361St
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Preparing for FDA Inspections 363of
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Advantages in the pharmaceutical in
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18The Common Technical Document for
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New drug approval process 3806. Exa
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New drug approval process 382and fi
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New drug approval process 384X Desc
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New drug approval process 386manufa
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New drug approval process 388Except
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New drug approval process 3904. Dis
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New drug approval process 3922. App
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New drug approval process 394A subs
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New drug approval process 396pharma
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New drug approval process 398which
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New drug approval process 400bindin
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New drug approval process 4022. Hum
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New drug approval process 4043. The
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New drug approval process 406includ
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New drug approval process 408Detail
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New drug approval process 410Table
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New drug approval process 412be app
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New drug approval process 4142. Spo
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New drug approval process 416III. O
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New drug approval process 418requir
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New drug approval process 420the dr
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20Institutional Review Board/ Indep
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New drug approval process 424will o
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New drug approval process 426sugges
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New drug approval process 428to obt
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New drug approval process 4304. A d
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New drug approval process 432• Th
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New drug approval process 4342. A s
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New drug approval process 4363. Doc
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21Quality AssuranceEarl W.HulihanME
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New drug approval process 440knowle
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New drug approval process 442* Nonc
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New drug approval process 444Protoc
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New drug approval process 4465.1.1
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New drug approval process 448of cli
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New drug approval process 450the li
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New drug approval process 452and or
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New drug approval process 454VI. IN
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New drug approval process 456each d
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New drug approval process 458Review
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New drug approval process 460(e.g.,
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New drug approval process 462XV. SU
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New drug approval process 464of leg
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New drug approval process 466Theore
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New drug approval process 468opinio
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New drug approval process 470produc
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New drug approval process 4727. Ins
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New drug approval process 474establ
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New drug approval process 476QP Qua
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A new requirement to the clinical s
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New drug approval process 490II. NO
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New drug approval process 492chemis
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New drug approval process 494toxico
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New drug approval process 496Physic
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New drug approval process 498PART I
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New drug approval process 5001. Doe
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New drug approval process 502the pr
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26The Evolving SMO in the United St
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The evolving SMO in the United Stat
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27Accelerating New Product Approval
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New drug approval process 518B. The
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New drug approval process 520object
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New drug approval process 522The FD
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Acronyms and InitialismsAdapted fro
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Acronyms and initialisms 526ANOVAAO
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Acronyms and initialisms 528CCRA Ce
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Acronyms and initialisms 530DESDESI
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Acronyms and initialisms 532FCCSETF
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Acronyms and initialisms 534ICICDIC
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Acronyms and initialisms 536LVPMAMA
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Acronyms and initialisms 538NIDANID
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Acronyms and initialisms 540OTCOMOT
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Acronyms and initialisms 542RAPSRCC
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Acronyms and initialisms 544USANUSC
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Index 547indexing, 191labeling, 192
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Index 549inspections, 228Investigat
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Index 551regulatory obligations, 50
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Index 553acute toxicology studies,
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Index 555Uncontrolled trials, 142,
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