Bioequivalence and Bioavailability Forum • GLP and GCP

GLP and GCP [Bioanalytics]

posted by Ohlbe – France, 2009-05-18 12:22 (6252 d 06:54 ago) – Posting: # 3694
Views: 7,178

Dear Helmut,

Basically, what NewInPK and you are suggesting is to do ISR, but with a different method :-)

Oh, another possible source of problems, not studied during validation, but which would be found this way: the influence of some excipients, such as Tween 80 or PEG 400. Not found in BE studies, but common in pre-clinical, and possibly in early clinical trials. Can cause matrix effects. Several publications showing these substances to be problematic after IV administration ; possibly also after oral administration.

❝ I know at least one. :-D

The French inspector I know you have met is a GCP inspector, not GLP. But I've heard he works closely with his GLP colleagues.

Regards
Ohlbe

Complete thread:

OTC and Contraceptives Geokad 2009-04-14 18:15
- OTC/Contraceptives: Interferences Helmut 2009-04-14 19:45
  - OTC/Contraceptives: Interferences Ohlbe 2009-04-17 17:49
    - OTC/Contraceptives: Interferences ElMaestro 2009-04-19 05:44
      - OTC/Contraceptives: Interferences Helmut 2009-04-19 14:36
        
        OTC/Contraceptives: Interferences ElMaestro 2009-04-21 01:20
        
        Selectivity in validation Helmut 2009-04-21 13:19
- OTC and Contraceptives NewInPK 2009-05-13 02:20
  - GLP vs. Good Scientific Practice Helmut 2009-05-16 16:49
    - GLP vs. Good Scientific Practice Ohlbe 2009-05-17 23:09
      - GLP vs. Good Scientific Practice Helmut 2009-05-17 23:42
        
        GLP and GCPOhlbe 2009-05-18 10:22
        
        GLP and GCP Helmut 2009-05-18 11:31