Evaluation of Generic Drugs Using Intra-Individual Variation Index

Autor:	Miki Fukuoka, Mikio Masada, Toshiaki Nakamura, Hitoshi Tsukamoto, Nobuyuki Goto, Kyohei Watanabe
Rok vydání:	2006
Předmět:	Food intake Index (economics) Pharmacokinetics business.industry Sampling schedule Statistics Cmax Medicine Bioequivalence Pharmacology Intra individual business Standard deviation
Zdroj:	Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences). 32:1145-1151
ISSN:	1882-1499 1346-342X
DOI:	10.5649/jjphcs.32.1145
Popis:	We previously reported that the protocols of bioequivalence studies on generic pravastatin sodium had not been standardized. The bioequivalence of generic drugs is confirmed by crossover studies using healthy volunteers. In this study, we examined protocols for bioequivalence studies on generic itraconazole (ITCZ) formulations which show poor absorption.Based on pharmacokinetic parameters obtained from pharmaceutical companies, we evaluated the protocols for studies on 5 generic formulations and the results of these studies. The sampling schedule, number of subjects and food intake status were found to be different for each study and there were also differences in the intra-individual variation index for Cmax and AUCt.In conclusion, it is difficult to accurately evaluate the quality of bioequivalence studies only on the basis of mean and standard deviation values that have been made publicly available.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::91b84bcb4d2a6a9927f1a1e4e00f166e https://doi.org/10.5649/jjphcs.32.1145 Zobrazit plný text záznamu