Q1a guideline

GUIDELINE FOR GOOD CLINICAL PRACTICE

1 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 substance or drug product that is sufficient for a

  Guidelines, Q1a guideline

EVALUATION FOR STABILITY DATA - ICH Official …

EVALUATION OF STABILITY DATA 1. INTRODUCTION 1.1 Objectives of the Guideline This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline “Q1A(R)

  Guidelines, Data, Evaluation, Stability, Evaluation for stability data

Literatur Clotrimazol ZL NRF - zentrallabor.com

26 | PHARM. ZTG. | 160 JG. | 17. 9. 2015 | 38. AUSG. PHARMAZIE 2800 unter Bestätigung des bisher allgemein vorgeschlagenen »rezeptierbaren pH-Bereichs« des ...