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International Pharmaceutical Product Registration, Second Edition: 200 (Drugs and the Pharmaceutical Sciences)From CRC Press
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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.
- Sales Rank: #4050312 in eBooks
- Published on: 2016-04-19
- Released on: 2016-04-19
- Format: Kindle eBook
Review
'... 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
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