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ICH Quality Guidelines: An Implementation Guide

✍ Scribed by Andrew Teasdale (Editor), David Elder (Editor), Raymond W. Nims (Editor)


Publisher
Wiley
Year
2017
Tongue
English
Leaves
734
Category
Library

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No coin nor oath required. For personal study only.

✦ Synopsis


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

✦ Subjects


Quality Control;Industrial, Manufacturing & Operational Systems;Engineering;Engineering & Transportation;Analytic;Chemistry;Science & Math;Industrial & Technical;Chemistry;Science & Math;Pharmacy;Pharmacology;Pharmacy;Allied Health Services;Medicine & Health Sciences;New, Used & Rental Textbooks;Specialty Boutique;Pharmacology;Basic Sciences;Medicine;Medicine & Health Sciences;New, Used & Rental Textbooks;Specialty Boutique;Chemistry;Science & Mathematics;New, Used & Rental Textbooks;Specialty B


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