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RegisterYes, but why the heck? [Regulatives / Guidelines]
Dear Sir,
I fully agree with your views. CDSCO is requesting the literature of toxicity data of the Innovator or other generic drugs marketed in other countries, if it is available in the public domain only for new drugs not approved in India for granting permission to conduct BE studies in Indian population with such drugs.
I fully agree with your views. CDSCO is requesting the literature of toxicity data of the Innovator or other generic drugs marketed in other countries, if it is available in the public domain only for new drugs not approved in India for granting permission to conduct BE studies in Indian population with such drugs.
—
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:
- Tox studies before generic BE Helmut 2012-11-04 17:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Tox studies before generic BE drgunasakaran1 2012-11-05 10:02
- Yes, but why the heck? Helmut 2012-11-05 12:04
- Clearly because... ElMaestro 2012-11-05 13:08
- Yes, but why the heck?drgunasakaran1 2012-11-06 04:43
- Yes, but why the heck? Helmut 2012-11-05 12:04
- Tox studies before generic BE drgunasakaran1 2012-11-05 10:02
Ing. Helmut Schütz