Homework ;-) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-07-13 17:25 (281 d 10:33 ago) – Posting: # 21690
Views: 555

Hi Mauricio,

see also this post #3.

» For example, comparing tablet vs suspension (with same dosage), …

Both are immediate release formulations. Hence, the BE-GL (details in APPENDIX III).

» … extende release vs immediate release, tablet 500 mg vs tablet 250 mg (with same drug).

MR-GL Section 5. Note that this is not the generic pathway but a hybrid application (you would additionally need clinical studies). See section 5.2 for the ‘exceptional cases’ where they might be waived. Personally I haven’t see one so far.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 11 (0 registered, 11 guests [including 4 identified bots]).
Forum time: Wednesday 03:58 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

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