Open access · Peer reviewed · No APCs
Short CommunicationJournal of Young PharmacistsVol. 8 | Issue 4 | 2016 | pp. 500–504Open access
Adoption and Reasons for Withdrawal of ICH Q1F Guidelines
- 1,
- 2,
- 1*
- 1 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA.
- 2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA.
Published in Journal of Young Pharmacists
Correspondence: Muddukrishna Badamane Sathyanarayana
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA.
Email: krishna.mbs@manipal.edu
Copyright: © 2016 Manuscript Technomedia. This is an open access article.
- Published:
- Aug 22, 2016
How to cite
Jadeja, S., kulyadi, G. P., & Sathyanarayana, M. B. (2016). Adoption and Reasons for Withdrawal of ICH Q1F Guidelines. Journal of Young Pharmacists, 8(4), 500–504. https://doi.org/10.5530/jyp.2016.4.31
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 Due to some reasons the guidelines were withdrawn.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.
Keywords
Subject
Article metadata
| Title | Adoption and Reasons for Withdrawal of ICH Q1F Guidelines |
|---|---|
| Authors | Siddharth Jadeja; Girish pai kulyadi; Muddukrishna Badamane Sathyanarayana |
| Affiliations | Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA.; Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal-576104, Karnataka, INDIA. |
| Corresponding author | krishna.mbs@manipal.edu |
| Journal | Journal of Young Pharmacists |
| Volume / Issue | Vol. 8, Issue 4 (2016) |
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