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Back to the forum  Query: 2017-11-22 17:37 CET (UTC+1h)
 
bhargavj12
Junior

India,
2017-07-10 19:59

Posting: # 17530
Views: 990
 

 Bioequivalence study of class II molecule [Regulatives / Guidelines]

Hello.... Is it possible to do Bioequivalence study of Class II products in India????
examples of Class II products are Hydrocodon, Oxycodon, metapon etc...


Edit: Please don’t shout! [Helmut]
Helmut
Hero
Homepage
Vienna, Austria,
2017-07-10 20:21

@ bhargavj12
Posting: # 17531
Views: 807
 

 BE of Schedule II drug (India)

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).

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bhargavj12
Junior

India,
2017-07-11 06:05
(edited by Ohlbe on 2017-07-11 10:03)

@ Helmut
Posting: # 17532
Views: 781
 

 BE of Schedule II drug (India)

» 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]
jag009
Hero

NJ,
2017-07-14 05:52

@ bhargavj12
Posting: # 17545
Views: 669
 

 BE of Schedule II drug (India)

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
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