ICH Q1 F guideline provided astability data package for the registration applications of drug substance and drug product in Climatic Zones III (hot and dry) and IV (hot and humid). These guidelines were adopted by the ICH in February 2003 and subsequently implemented in the ICH regions. Due to some reasons the guidelines were withdrawn. This review article describes the development of the concept of the climatic zones, the introduction of the guideline Q1F, its adoption, objections to these guidelines, its withdrawal and reasons for the withdrawal and its alaternative that was proposed.
All Science Journal Classification (ASJC) codes
- Pharmacology, Toxicology and Pharmaceutics(all)