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ICH Quality Guidelines : An Implementation Guide (Hardcover) (Andrew Teasdale & David Elder & Raymond W.

ICH Quality Guidelines : An Implementation Guide (Hardcover) (Andrew Teasdale & David Elder & Raymond W. - image 1 of 1

About this item

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)
Number of Pages: 721
Genre: Medical, Technology, Science
Format: Hardcover
Publisher: John Wiley & Sons Inc
Author: Andrew Teasdale & David Elder & Raymond W. Nims
Language: English
Street Date: October 9, 2017
TCIN: 52281952
UPC: 9781118971116
Item Number (DPCI): 248-44-7660
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