Adoption and reasons for withdrawal of ICH Q1F guidelines

Siddharth Jadeja; Kulyadi Girish Pai; Badamane Sathyanarayana Muddukrishna

doi:10.5530/jyp.2016.4.31

Adoption and reasons for withdrawal of ICH Q1F guidelines

Siddharth Jadeja, Kulyadi Girish Pai, Badamane Sathyanarayana Muddukrishna

Research output: Contribution to journal › Article › peer-review

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 Due to some reasons the guidelines were withdrawn.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.

Original language	English
Pages (from-to)	500-504
Number of pages	5
Journal	Journal of Young Pharmacists
Volume	8
Issue number	4
DOIs	https://doi.org/10.5530/jyp.2016.4.31
Publication status	Published - 01-10-2016

All Science Journal Classification (ASJC) codes

Pharmacology, Toxicology and Pharmaceutics(all)

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10.5530/jyp.2016.4.31

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AB - 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 Due to some reasons the guidelines were withdrawn.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.

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Adoption and reasons for withdrawal of ICH Q1F guidelines

Abstract

All Science Journal Classification (ASJC) codes

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