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jag009 ★★★ NJ, 2019-11-11 22:43 (1620 d 15:23 ago) Posting: # 20785 Views: 3,952 |
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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 |
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Helmut ★★★   Vienna, Austria, 2019-11-21 15:01 (1610 d 23:05 ago) @ jag009 Posting: # 20852 Views: 2,360 |
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Hi John, are you seriously expecting answers from the 768 (!) members from ![[image]](https://static.bebac.at/pics/IN-S.png) ?SCNR. — 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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Ajit Thorat ☆ India, 2019-12-09 14:29 (1592 d 23:37 ago) @ jag009 Posting: # 20965 Views: 1,691 |
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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] |
Ing. Helmut Schütz