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

posted by NK – India, 2024-08-06 06:06 (290 d 03:59 ago) – Posting: # 24140
Views: 1,867

Hi Achievwin,

❝ Recently one CRO asked us for sub-acute and acute study report for an injectable product. They say Indian DCGI is asking for acute and sub-acute animal studies as a condition for BE No Objections certificate for conducting a BE study. The product under consideration a product meant for US-FDA submission and it has been a FDA practice and basic understanding that non-clinical safety and clinical efficacy information is deemed established and we refer back to the approved labeling.


As per the Indian Regulatory requirement, for getting NOC for conducting BA/BE studies of Injectable product, applicant should submit sub-acute toxicity study.

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".

❝ Is this a new requirement and how other companies handling the issue? To me the requirement seems to question age old and well understood principle.


This is not the new requirement.

Regards
NK

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,679 registered users;
43 visitors (0 registered, 43 guests [including 14 identified bots]).
Forum time: 10:06 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