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

posted by Helmut Homepage – Vienna, Austria, 2018-09-03 14:46 (1445 d 20:18 ago) – Posting: # 19230
Views: 2,689

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 🖖 [image]
Helmut Schütz
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 4 (0 registered, 4 guests [including 1 identified bots]).
Forum time: Friday 11:04 CEST (Europe/Vienna)

Doctors are men who prescribe medicines of which they know little,
to cure diseases of which they know less,
in human beings of whom they know nothing.    Voltaire

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