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Q1c Stability Testing Requirements For New Dosage

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Q 1 A (R2) Stability Testing of new Drug Substances and ...

Q 1 A (R2) Stability Testing of new Drug Substances and ...

www.ema.europa.eu

STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS 1. INTRODUCTION 1.1. Objectives of the Guideline The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug …

  Testing, Stability, Stability testing

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