Consideration of ethnic factors during drug approval process
Journal Title: International Journal of Pharmacology and Clinical Research (IJPCR) - Year 2018, Vol 2, Issue 1
Abstract
Purpose To determine feasibility of drug registration for the selected drugs at USFDA based on the ICH E5 guideline. Methods Methodology involves two steps, they are 1. Determination of ethnic sensitivity of the selected drugs based on factors such as pharmacokinetics (PK), pharmacodynamic (PD), therapeutic range, and metabolism etc., given in appendix D of ICH E5 guidelines. 2. Determination of the need for the bridging studies after determining ethnic sensitivity of the selected drugs based on the ICH E5 guidelines. Results After the extensive analysis of the selected drugs, drugs like nicorandil, may be ethnically insensitive based on ICH E5 guideline. Drugs like, nicorandil, may be approved by USFDA without need of bridging studies because they are ethnically insensitive and medical practice across the ICH countries is mostly similar. The efficacy and safety of these drugs is demonstrated by the fact that these drugs are on the market for at least 25 years and prescribed in the millions of the patients. Conclusion Nicorandil may be ethnically insensitive among the selected drugs based on the ICH E5 guideline. Drugs like nicorandil may be approved by USFDA (United States Food and Drug Administration) without need of bridging studies
Authors and Affiliations
Sudershan Goud Gokari
Keywords
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