ICH Quality Guidelines: * Overview and Orientation * Introduction * Part I: Stability [Q1A(R2), Q1B, Q1C, Q1D, Q1E] * Part II: Analytical Validation [Q2(R1)] *

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integra

A document may be based on accurate medical and scientific information, follow guidelines precisely, and be well written in clear and correct language, but may

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presen

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequatel