ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3

S10 Photosafety Evaluation of Pharmaceuticals

Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use Step 3 NOTE FOR GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FOR HUMAN USE (EMEA/CHMP/ICH/126642/2008) APPROVAL BY CHMP

ICH guidelines: inception, revision, and implications for drug development.

Since the inception of the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) in 1990, six-party Expert Working Groups (EWG) have developed and revised numerous guidelines on preclinical safety evaluation (Table 1). The six parties to ICH represent the regulatory bodies and pharmaceutical manufacturing organizations in...

An in vitro model of chemotherapeutic damage to mesenchymal stem cells

s of the 33 Annual Meeting of the United Kingdom Environmental Mutagen Society, 12 14 July 2010 at the University of Derby, UK. 1. Photogenotoxicity – science without application? Daniel Bauer Novartis Institutes of BioMedical Research, Preclinical Safety, 4002 Basel, Switzerland In 1999 the International Workshop on Genotoxicity Test Procedures prepared recommendations for photogenotoxicity te...

ICH Q8: Pharmaceutical Development. Regulatory Requirements Directed by the New Note for Guidance (EMEA/CHMP/167068/2004) in Comparison to the Previous Guideline (CPMP/QWP/155/96). A Critical View from the Generic Pharmaceutical Industry

List of abbreviations 4 Introduction 5 The history and development of the new guideline ICH Topic Q8 5 The contents and requirements according to the new guideline 9 Comparison of the current guideline ICH Q8 with the previous guideline 15 Comparison of both guidelines – a summary 28 The term Design Space-Integration into ICH Q8, Q9 and Q10 29 Requirements of the new guideline for the innovatin...