International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences) - Image 1

£118.59

CRC Press International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)

Name: International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)
Brand: CRC Press
Price: 118.59 GBP
Availability: InStock

Pharmacy - Dispensing

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£119 today · previous high £119 · all-time low £115

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Description

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.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1420081764
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 26 August 2009
Listed Since: 17 January 2008

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CRC Press International Pharmaceutical Product Registration: 200 (Drugs and the Pharmaceutical Sciences)

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