ICH Quality Guidelines : An Implementation Guide (PDF)

ICH Quality Guidelines : An Implementation Guide (PDF)

by Raymond W. Nims , David Elder and Andrew Teasdale (editors)

This book provides an integrated picture of how the guidelines inform drug development strategic planning and decision-making by examining the consequences and practical application of multidisciplinary International Conference on Harmonization (ICH) themes . Offers a major reference source for practitioners addressing the dual problem of interpretation and practical application of ICH guidelines .

• Addresses a persistent demand for interpretation, training, and implementation examples of ICH guidelines through case studies .

• Helps readers comprehend and apply ICH standards by using case studies

• Offers insightful information about the creation of the guidelines , including chapters written by authors with experience creating or applying the rules .

• Addresses stability testing , analytical method validation , contaminants , pharmaceuticals and goods derived from biotechnology and good manufacturing practice (GMP) .

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