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RegisterBENOC for anti cancer [Regulatives / Guidelines]
Dear Mr Acccutest,
We need to get BENOC from DCGI for all bioequivalence studies with anti cancer drugs irrespective of the approval status.
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.
❝ 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
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
Complete thread:
- BENOC for anti cancer accutest 2015-06-06 12:55 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BENOC for anti cancer krish85 2015-06-08 08:47
- BENOC for anti cancer accutest 2015-06-09 13:23
- BENOC for anti cancer krish85 2015-06-10 06:36
- BENOC for anti cancer accutest 2015-06-15 11:36
- BENOC for anti cancer krish85 2015-06-10 06:36
- BENOC for anti cancer accutest 2015-06-09 13:23
- BENOC for anti cancerdrgunasakaran1 2015-07-01 17:31
- BENOC for anti cancer accutest 2015-07-02 07:18
- BENOC for anti cancer krish85 2015-06-08 08:47
Ing. Helmut Schütz