Электронная книга: David Elder «ICH Quality Guidelines. An Implementation Guide»

ICH Quality Guidelines. An Implementation Guide

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 tohelp 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)

Издательство: "John Wiley&Sons Limited"

ISBN: 9781118971123

электронная книга

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David Elder

David Matthew Elder (September 23, 1975 in Atlanta, Georgia), is a professional baseball player who played pitcher in the Major Leagues from 2002-2003. He played for the Cleveland Indians. He was the pitcher who surrendered Rafael Palmeiro's 500th career home run on May 11, 2003 at The Ballpark in Arlington.

External links

*baseball-reference|id=e/elderda01

Источник: David Elder

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David ElderICH Quality Guidelines. An Implementation GuideExamining 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… — @John Wiley&Sons Limited, @ @ @ @ Подробнее...
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