Dear Balaji,
You can check the ANVISA guidelines (you might not find In English version):
- RDC 27/2012
- RDC 37/2010
In Brazil, the BE and BA studies have do be done by ANVISA Certified Laboratories. However, the manufacturer is responsible to guarantee the quality of the Medication.
The BE/BA studies are done in healthy volunteers, the number varies from 18 to 24 people. In some cases, the tests require patient subjects, such as studies for anti câncer drugs which the IMP risk/ benefit ratio is too high (because of toxicity).
Best regards,
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Sinara Alves MBA,RPH
CMS Produtos Médicos
Anápolis - Goiás
Brazil
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Original Message:
Sent: 04-15-2014 11:01
From: BALAJI GANDHE
Subject: Drug Registration with ANVISA
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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