BA/BE studies in patients [Regulatives / Guidelines]

posted by rafimmc – 2007-09-20 11:49 (6858 d 12:32 ago) – Posting: # 1097
Views: 4,584

Dear Sir,
I have few questions.
1. Is there any specific class of drugs for which BA/BE is done in patients?
2. Regulatory guidelines (FDA, EMEA & HC) do not specify the gruop/class of drugs for which BA/BE studies are done in patients instead of healthy volunteers. Is there any specific guideline availble?

Please help.

Thanks and regards,
Rafiullah

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