Bioequivalence and Bioavailability Forum • US FDA guidance

US FDA guidance [Bioanalytics]

posted by chandru – India, 2018-05-27 23:41 (2154 d 00:35 ago) – Posting: # 18820
Views: 3,330

Hi thank you all for your valuable inputs.

After the release of FDA guidance May 2018, is it mandatory to evaluate stability of molecule in presence of potentially interfering substance?

Is it mandatory to evaluate for all the concomitant medication given to subjects in a particular study or is it ok if we do it for regularly administered drug(eg., Some defined 10 drugs, putting in the SOP and evaluating it) ?

Regards,
Chandru

Complete thread:

Concomitant medications experiment in method validation chandru 2018-02-14 07:31
- Concomitant medications experiment in method validation Obinoscopy 2018-05-02 04:05
- Concomitant medications experiment in method validation ElMaestro 2018-05-02 09:25
  - Enhancement from concomitant medications Ohlbe 2018-05-02 11:36
    - Enhancement from concomitant medications ElMaestro 2018-05-02 12:23
      - Enhancement from concomitant medications Ohlbe 2018-05-02 12:34
        
        US FDA guidancechandru 2018-05-27 21:41