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E-raamat: International Pharmaceutical Product Registration

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  • Formaat: 852 pages
  • Ilmumisaeg: 19-Apr-2016
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781040205921
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International Pharmaceutical Product RegistrationSuurem pilt
  • Formaat: 852 pages
  • Ilmumisaeg: 19-Apr-2016
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781040205921
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Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.

The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.

This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.

The book is organized into six highly practical segments:













Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products)









This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

Arvustused

'...it is a truly encyclopedic discussion of the CTD... Some of the material in the book is delightfully unexpected and very useful... it is a very useful book, and its content and style are most suitable for advanced study of regulatory processes or to keep by one's desk as a reference text.' - Drug Information Journal '... the book is a must-have for all experts working in the area of R&D, in particular pharmaceutical development, toxicology, pharmacology, clinical development and, of course, regulatory affairs.

It will help to avoid mistakes that may lead to delays in submission of applications or deficiency letters that are received as a surprise by the applicants. In other words, to provide patients with medicines earlier, you had better have the book available next to your desk.'

'...the book does provide a very good overview of all aspects of the drug registration requirements and deserves a place in every pharmaceutical library.' The British Toxicology Society Newsletter

Preface vii
Acknowledgments xi
Contributors xv
Part 1: Introduction and Specific Requirements
The Common Technical Document---A Global Format for Registration Files
1(13)
Anthony C. Cartwright
The Electronic Common Technical Document
14(12)
Geoffrey Williams
CTD Module 1---Administrative Information
26(21)
Roger Croswell
Anthony C. Cartwright
Environmental Risk Assessment
47(31)
David J. Snodin
Part 2: Common Technical Document Summaries
Quality Overall Summary
78(11)
Anthony C. Cartwright
The Nonclinical Overview and Summary
89(18)
Richard Lee
The Clinical Overview and Summary
107(12)
Chantal Le Floch
Patricia Maillere
Part 3: Quality---Drug Substance and Drug Product
Drug Substance---General Information
119(5)
Anthony C. Cartwright
Drug Substance---Manufacture
124(12)
Anthony C. Cartwright
Drug Substance---Characterization
136(18)
Anthony C. Cartwright
David J. Snodin
Control of Drug Substance
154(15)
Anthony C. Cartwright
Drug Substance and Drug Product---Container/Closure
169(10)
Brian R. Matthews
Drug Product---Description and Composition
179(5)
Brian R. Mattews
Drug Product---Pharmaceutical Development
184(26)
J. Michael Morris
Drug Product---Manufacture and Process Validation
210(24)
Brian R. Matthews
Drug Product---Excipients
234(14)
Brian R. Matthews
Control Tests on the Finished Product
248(16)
Henk J. de Jong
Reference Standards or Materials
264(5)
Anthony C. Cartwright
Drug Substance and Drug Product Stability
269(21)
Anthony C. Cartwright
Transmissible Spongiform Encephalopathy Agent and Adventitious Agent Requirements for Non-Biological Pharmaceutical Products
290(10)
Brain R. Matthews
Part 4: Nonclinical Studies
Nonclinical Testing Strategy
300(23)
Klaus Olejniczak
Rolf Bass
Pharmacology
323(13)
James W. McBlane
Nonclinical Pharmacokinetics and Toxicokinetics
336(41)
Richard J. Weaver
Roeline Jochemsen
Single and Repeat Dose Toxicity
377(25)
Barry S. Levine
Genotoxicity
402(17)
Peter Kasper
Carcinogenicity
419(10)
Gerd Bode
Reproductive and Developmental Toxicity
429(12)
John Baldwin
Safety Pharmacology Testing: Past, Present, and Future
441(26)
Paul Baldrick
Immunotoxicology
467(11)
Danuta Herzyk
Local Tolerance and Other Toxicity Studies
478(12)
Andrew Makin
Part 5: Clinical Studies
Bioavailability and Bioequivalence Studies
490(30)
Iain J. McGilveray
Pharmacokinetics in Man
520(17)
Don J. Nichols
Don K. Walker
Pharmacodynamics
537(17)
Corinne Seng Yue
Pina D'Angelo
Murray P. Ducharme
Statistial Concepts in the Design and Analysis of Clinical Trials
554(20)
Richard Kay
Efficacy and Safety Clinical Studies
574(15)
David Jefferys
Postmarketing Evaluation
589(14)
H. Guenter Hennings
Pharmacovigilance and Risk Management
603(19)
Brian Edwards
Mary Teeling
Markku Toivonen
Pregnancy and Children
622(11)
H. Guenter
Ageing Populations and Development of Medicinal Products
633(25)
Jean-Marc Husson
Jean-Marie Vetel
Good Clinical Practice
658(27)
Laura Brown
Prevention and Detection of Fraud in Clinical Trials
685(12)
Jane Barrett
Part 6: Special Products and Modeling
Aspects of Biological and Biotechnological Medicinal Products
697(20)
Manfred G. Haase
Device-Drug Combination Products
717(38)
Brian R. Matthews
Recommendations for Toxicological Evaluation of Nanoparticle Medicinal Products
755(7)
Jean-Roger Claude
Modeling and Medical Product R&D
762(12)
Jean-Pierre Boissel
Michel Cucherat
Patrice Nony
Francois Gueyffier
Francois-Henri Boissel
Annex 1: List of Acronyms and Abbreviations 774(10)
Anthony C. Cartwright
Annex 2: List of Key Technical and Regulatory Information Sources 784(3)
Anthony C. Cartwright
Brian R. Matthews
Index 787
Brian R. Matthews, Anthony C. Cartwright
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