(DOWNLOAD) "ICH Quality Guidelines" by Andrew Teasdale, David Elder & Raymond W. Nims ~ eBook PDF Kindle ePub Free

June 04, 2021

eBook details

Title: ICH Quality Guidelines
Author : Andrew Teasdale, David Elder & Raymond W. Nims
Release Date : January 29, 2017
Genre: Pharmacology & Toxicology,Books,Professional & Technical,Medical,
Pages : * pages
Size : 33480 KB

Description

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.

•   Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
•   Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
•   Uses case studies to help readers understand and apply ICH guidelines
•   Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
•   Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

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