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Helmut ★★★   Vienna, Austria, 2012-11-04 18:25 (4981 d 19:46 ago) Posting: # 9500 Views: 3,823 |
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Dear all, in two countries ( ![[image]](http://bebac.at/pics/RU.png) and – according to this post – ![[image]](http://bebac.at/pics/IN.png) ) preclinical toxicity studies of the API are required before initiating a BE study for generic application. No idea about India, but in Russia two rodent species are required. I’m wondering what might be the scientific (!) rationale behind:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drgunasakaran1 ★★  2012-11-05 11:02 (4981 d 03:09 ago) @ Helmut Posting: # 9501 Views: 3,063 |
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Dear Sir, ❝ 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 |
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Helmut ★★★ Vienna, Austria, 2012-11-05 13:04 (4981 d 01:07 ago) @ drgunasakaran1 Posting: # 9502 Views: 3,070 |
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Dear Dr. Gunasakaran, THX, I knew this document (August 2009, right?). IMHO such a requirement is fucking crazy (as is the Russian one); the scientific rationale behind (see the first two remarks in my original post) is beyond my intellectual reach. I know that the development process of guidelines in India and Russia is not the most transparent one (to say it politely)… Did anybody ever try to challenge it? — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2012-11-05 14:08 (4981 d 00:03 ago) @ Helmut Posting: # 9503 Views: 3,002 |
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Hi Helmut, I know from experience that if you ask a person who has a lot of innovator experience and zero BE experience to come up with a concept on how to show BE then the outcome will be
Rather than banging your head into the wall you should just be grateful that you haven't been asked to include placebo arms or show equivalence on basis of Kaplan-Meier plots... ...yet. — Pass or fail! ElMaestro |
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drgunasakaran1 ★★ 2012-11-06 05:43 (4980 d 08:28 ago) @ Helmut Posting: # 9506 Views: 2,969 |
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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. — 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 |
Ing. Helmut Schütz