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Основной контент книги ICH Quality Guidelines
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Book duration 736 pages

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ICH Quality Guidelines

An Implementation Guide
Читайте только на Литрес

The book cannot be downloaded as a file, but can be read in our app or online on the website.

$426.60

About the book

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

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Age restriction:
0+
Release date on Litres:
21 June 2018
Volume:
736 p.
ISBN:
9781118971123
Total size:
9.0 МБ
Total number of pages:
736
Publisher:
Copyright holder:
John Wiley & Sons Limited
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