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bhargavj12 ☆ India, 2017-07-10 21:59 (2474 d 18:06 ago) Posting: # 17530 Views: 4,475 |
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Helmut ★★★   Vienna, Austria, 2017-07-10 22:21 (2474 d 17:44 ago) @ bhargavj12 Posting: # 17531 Views: 3,870 |
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Hi bhargavj12 ❝ Is it possible to do Bioequivalence study of Class II products in India? I guess you mean Schedule II drugs. If yes, sure, why not? Been there, done that. But: The procedure (to be initiated after approval by DGGI and the IEC) at the Central Bureau of Narcotics was painfully slow (in 2010). — 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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bhargavj12 ☆ India, 2017-07-11 08:05 (2474 d 08:00 ago) (edited by Ohlbe on 2017-07-11 10:03) @ Helmut Posting: # 17532 Views: 3,898 |
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❝ I guess you mean Schedule II drugs. Thank you for the reply Yes I mean to say for Schedule II drugs. Is there any specific difference or things which is to be taken care for Schedule II? or any specific guidance or literature available for the same to conduct in India? Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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jag009 ★★★ NJ, 2017-07-14 07:52 (2471 d 08:13 ago) @ bhargavj12 Posting: # 17545 Views: 3,816 |
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Done a few over the last two years in India clinics. No much issues except for the hassles of getting import permit and export license (USA). Study wise, no big issues, same as regular BA/BE studies. J |
Ing. Helmut Schütz