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Debbie ★ India, 2014-12-23 08:13 (3410 d 03:04 ago) Posting: # 14148 Views: 3,519 |
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Dear Sir, As a CRO professional, we have received the studies for Egypt market. For that we would like to know about the conduct of Bioequivalence study. Whether is it mandatory to conduct the bio-equivalence study in Egyptian population to meet the requirements of EDA (Egypt Drug Authority) or EDA (Egypt Drug Authority) will accept the bio-equivalence study conducted in compliance to the requirements of EDA (Egypt Drug Authority) in any other country population (Other than Egypt). In listed EDA guidelines on the Bioequivalence study are not detailed about this. Please respond the mail and advise me to take necessary steps for the conduct of the BE study. Thanks & Regards, Santhosh Kumar B Edit: Category changed and subject line changed. [Helmut] |
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Dr_Dan ★★ Germany, 2015-01-21 17:04 (3380 d 18:13 ago) @ Debbie Posting: # 14308 Views: 2,444 |
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Dear Santhosh Kumar B The term “Egyptian” refers to nationality which is irrelevant for the assessment of bioequivalence and other evaluation of drugs. You should focus on ethnicity which is one factor that may account for the observed differences in both pharmacokinetics (PK) and pharmacodynamics (PD) of drugs, resulting in variability in response to drug therapy. Ethnic diversity in drug response with respect to safety and efficacy and the resulting differences in recommended doses have been well described for some drugs. Some of these differential responses may be related to the pharmacogenomics of a particular drug. However, for a bioequivalence study especially conducted as an inter-subject comparison the clinical relevance of variability in drug response due to pharmacogenomics of drug-metabolizing enzymes does not need to be considered since there is a wide consensus that formulations which are bioequivalent in one study population will also be bioequivalent in other study populations. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz