Bioequivalence and Bioavailability Forum • IM injection

IM injection [Regulatives / Guidelines]

posted by ray_be – India, 2010-03-24 07:32 (5943 d 04:45 ago) – Posting: # 4967
Views: 12,492

Dear all,

As per 21 CFR § 320.22, FDA shall waive the requirement for the submission of evidence obtained in-vivo demonstrating the bioavailability or bioequivalence of drug products that is a parenteral solution intended solely for administration by injection, then why for some intra muscular injection they are asking for a bioequivalence study?

Can any one tell me under which conditions bioequivalence studies are required to be conducted for intra muscular injection? These studies are meant for US submission.

It would be greatly appreciated, if any one provides me a published guidance for it.

Anticipating a positive response.

Regards

Raybe

Complete thread:

IM injectionray_be 2010-03-24 06:32
- IM injection Dr_Dan 2010-04-14 10:48
- IM injection ElMaestro 2010-04-14 12:15
  - IM injection ray_be 2010-04-14 13:02
    - IM injection ElMaestro 2010-04-14 13:45
      - IM: absorption site! Helmut 2010-04-14 18:35
        
        IM: absorption site! Ohlbe 2010-04-15 00:40
        
        IM: absorption site! Helmut 2010-04-15 09:15
        IM: absorption site! ElMaestro 2010-04-15 09:39
        
        IM: absorption site! ray_be 2010-04-17 06:20
        
        IM: absorption site! ray_be 2010-04-17 06:25
        
        Quality of the questions asked. Helmut 2010-04-17 22:20