Acute and Sub-acute toxicity studies for FDA ANDAs [Regulatives / Guidelines]

posted by Achievwin – US, 2024-08-27 04:42 (269 d 07:02 ago) – Posting: # 24162
Views: 1,436

❝ The guideline says "For all injectable, the sub-acute toxicity should be submitted on the Test product of the sponsor, studied in at least two species for minimum 14 days".


❝ This is not the new requirement.


Most un scientific requirement.... neither FDA nor EMA ask this for generic products.

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,679 registered users;
128 visitors (0 registered, 128 guests [including 40 identified bots]).
Forum time: 11:45 CEST (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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