Bioequivalence and Bioavailability Forum • IM injection

IM injection [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2010-04-14 14:15 (5921 d 00:38 ago) – Posting: # 5123
Views: 11,075

Hi ray_be,

❝ 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?

When the drug is not formulated as a simple solution (for example emulsion) the quantitative and qualitative composiotion may affect the bioavailability. I would expect that to be a a deciding factor.

Best regards

EM.

Complete thread:

IM injection ray_be 2010-03-24 06:32
- IM injection Dr_Dan 2010-04-14 10:48
- IM injectionElMaestro 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