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portada ICH Quality Guidelines: An Implementation Guide
Type
Physical Book
Illustrated by
Publisher
Author
Language
English
Format
Hardcover
Dimensions
23.1 x 16.0 x 4.1 cm
Weight
1.11 kg.
ISBN13
9781118971116
Categories

ICH Quality Guidelines: An Implementation Guide

Raymond W. Nims (Illustrated by) · Andrew Teasdale (Illustrated by) · David Elder (Illustrated by) · Wiley · Hardcover

ICH Quality Guidelines: An Implementation Guide - Teasdale, Andrew ; Elder, David ; Nims, Raymond W.

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Synopsis "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 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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