BENOC for anti cancer [Regulatives / Guidelines]

posted by drgunasakaran1  – 2015-07-01 19:31 (4013 d 07:14 ago) – Posting: # 15007
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Dear Mr Acccutest,

❝ Can anyone suggest that for all the anti cancer drug BENOC is required or BENOC is not required if the drug is old (More than four years).


We need to get BENOC from DCGI for all bioequivalence studies with anti cancer drugs irrespective of the approval status.

❝ Is DCGI give us the permission to conduct the BE Study on healthy volunteers or we need to conduct the study on patients only?


It depends on the molecule. If the anti cancer drug does not have any cytotoxic potential, DCGI will permit to conduct study in healthy subjects.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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