Helmut
★★★
avatar
Homepage
Vienna, Austria,
2018-09-03 16:46
(2839 d 19:11 ago)

Posting: # 19230
Views: 4,131
 

 FDA: Dissolution Testing and Acceptance Criteria for IR… [BE/BA News]

Post reply
Dear all,

in August the FDA published the final Guidance for Industry

“Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances”

Since – like most agencies – the FDA doesn’t provide a change control here is the draft of August 2015 for comparison.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
 
UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
107 visitors (0 registered, 107 guests [including 28 identified bots]).
Forum time: 11:57 CEST (Europe/Vienna)

To propose that poor design can be corrected by subtle analysis techniques
is contrary to good scientific thinking.    Stuart J. Pocock

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5