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RegisterTox studies before generic BE [Regulatives / Guidelines]
Dear Sir,
As per Indian CDSCO Guidance on "Documents to be submitted for grant of permission to conduct Bioequivalence studies for export purpose", Pre-clinical single dose data and repeated dose toxicity data are required only if the drug is a new molecule not approved in India but approved in the other countries.
Whereas, in the case of Injectable preparation, the sub-acute toxicity should be submitted on the product of the sponsor, generated in two species for adequate duration.
❝ No idea about India, but in Russia two rodent species are required. I’m wondering what might be the scientific (!) rationale behind:
❝ • Tox studies have been successfully performed by the innovator.
As per Indian CDSCO Guidance on "Documents to be submitted for grant of permission to conduct Bioequivalence studies for export purpose", Pre-clinical single dose data and repeated dose toxicity data are required only if the drug is a new molecule not approved in India but approved in the other countries.
Whereas, in the case of Injectable preparation, the sub-acute toxicity should be submitted on the product of the sponsor, generated in two species for adequate duration.
—
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 BEdrgunasakaran1 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 BEdrgunasakaran1 2012-11-05 10:02
Ing. Helmut Schütz