Adoption and reasons for withdrawal of ICH Q1F guidelines

Jadeja, Siddharth and Pai, Girish K and Muddukrishna, BS (2016) Adoption and reasons for withdrawal of ICH Q1F guidelines. Journal of Young Pharmacists, 8 (4). pp. 500-504. ISSN 0975-1483

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Abstract

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 Due to some reasons the guidelines were withdrawn.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.

Item Type: Article
Uncontrolled Keywords: Guidelines; ICH; Q1F; stability; withdrawal.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Library
Date Deposited: 20 Aug 2016 14:58
Last Modified: 20 Aug 2016 14:58
URI: http://eprints.manipal.edu/id/eprint/146819

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