Hello All,
My company wants to register generic drug in Brazil (ANVISA). In order to prove equivalency with Reference drug we need to conduct BA/BE studies. I am looking for ANVISA's requirements BA/BE study. Can anyone suggest me where can I find the guidance documents for conducting BA/BE studies?
The main issue is we are not sure whether the drug should be tested on healthy volunteers or patient subjects for BA/BE studies. As for this drug US FDA requires to conduct the BA/BE studies in patients. Please help
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BALAJI GANDHE RAC
United States
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