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RegisterPatient population for bioequivalence study [Regulatives / Guidelines]
It is hard to provide a valuable opinion without knowing much details, namely whether you're talking about a biosimilar or generic. 
Generally, the product-specific guideline states in which condition should be bioequivalence study be performed. For instance, in USA diclofenac is approved for 3 indications but for BE only a study in subjects with osteoarthritis of the knee is required (https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm244644.pdf). If no product-specific guideline exists, I would recommend you to ask for scientific advice on which patient population should be selected for the BE study with clinical endpoint. If I were the Sponsor, I would pick the condition on which the primary endpoint presents less variability in the outcome.
Generally, the product-specific guideline states in which condition should be bioequivalence study be performed. For instance, in USA diclofenac is approved for 3 indications but for BE only a study in subjects with osteoarthritis of the knee is required (https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm244644.pdf). If no product-specific guideline exists, I would recommend you to ask for scientific advice on which patient population should be selected for the BE study with clinical endpoint. If I were the Sponsor, I would pick the condition on which the primary endpoint presents less variability in the outcome.
Complete thread:
- Patient population for bioequivalence study pash413 2017-10-04 15:44 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Patient population for bioequivalence studyDavidManteigas 2017-10-06 10:34
- Patient population for bioequivalence study pash413 2017-10-06 15:33
- Patient population for bioequivalence studyDavidManteigas 2017-10-06 10:34
Ing. Helmut Schütz