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1. CPMP ICH 380 95 ICH Topic Q 1 A Stability Testing Guidelines Stability Testing of New Drug Substances and Products Step 5 NOTE FOR GUIDANCE ON STABILITY TESTING STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS (CPMP ICH 380 95) This guideline replaces relevant section of previous guideline APPROVAL BY CPMP December 1993.
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3. ICH WHO AND SUPAC GUIDELINES ICH GUIDELINES INTRODUCTION The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe Japan and the United States and.
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5. ICH Q6A C 102 Specifications Test Procedures and Acceptance Criteria ICH Q6A 1 1 Objective of the Guideline Establishment of a single set of global specifications for new drug substances and products Guidance on the setting and justification of acceptance criteria and the selection of test procedures 1 2 Background!
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It's simple, fast, and convenient. ICH Guidelines zICH has developed over 45 harmonized guidelines zThe ICH Topics are divided into four major categories zQuality (Q) i e those relating to chemical and pharmaceutical Quality Assurance zSafety (S) i e those relating to in vitro and in vivo pre clinical studies zEfficacy (E) i e those relating to clinical studies in human subject. With the Xodo web app, you can now merge multiple PDFs into one, which is perfect for when you need to compile resources into one package to send to your colleagues.