jag009
★★★

NJ,
2019-11-11 21:43
(477 d 14:59 ago)

Posting: # 20785
Views: 3,340
 

 Generic submission in India [Regulatives / Guidelines]

Hi folks,

Can someone direct me to guidance doc(s) for generic submission in India? I would like to get some info on the comparative dissolution testing (is it like FDA where one has to carry out a recommended disso?), potency differences? I got the BE reqts part.

Thx
J
Helmut
★★★
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Vienna, Austria,
2019-11-21 14:01
(467 d 22:42 ago)

@ jag009
Posting: # 20852
Views: 1,805
 

 Dead silence in India

Hi John,

are you seriously expecting answers from the 768 (!) members from [image]?
SCNR.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Ajit Thorat
☆    

India,
2019-12-09 13:29
(449 d 23:14 ago)

@ jag009
Posting: # 20965
Views: 1,189
 

 Generic submission in India

Dear J

Please find below link

http://www.jpsbr.org/index_htm_files/JPSBR14RV4028.pdf

Additional information will be shared with you soon.

Thx
Ajit Thorat.


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 #5[Helmut]
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