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eswar lal ☆ Hyderabad, 2006-10-27 14:55 (7175 d 09:13 ago) Posting: # 329 Views: 7,713 |
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Dear Iwant to know, minimum requirements to open a new Bioavailablity and Bioequivalence facility for IND, ANDA submissions in India Please guide me in this regard |
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Helmut ★★★   Vienna, Austria, 2006-10-28 18:30 (7174 d 05:38 ago) @ eswar lal Posting: # 330 Views: 6,406 |
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Dear Eswar, as a first starting point I would recommend the recently published "Fortieth Report (WHO Technical Report Series No. 937)", which gives some guidelines for CROs in it's Annex 9 (Additional guidance for organizations performing in vivo bioequivalence studies). You may download the entire document here: 1.9MB PDF. — 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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eswar lal ☆ Hyderabad, 2006-10-30 06:07 (7172 d 17:01 ago) @ Helmut Posting: # 331 Views: 6,280 |
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Dear Sir thanks for ur prompt reply. I found the guideline very useful and informative. Please let me know if there is any specific Indian guideline related to opening of BA/BE unit. |
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Helmut ★★★ Vienna, Austria, 2006-10-30 12:10 (7172 d 10:58 ago) @ eswar lal Posting: # 336 Views: 6,358 |
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— 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 |
Ing. Helmut Schütz