Bioequivalence and Bioavailability Forum

GLP and GCP [Bioanalytics]

posted by Ohlbe – France, 2009-05-18 12:22 (5841 d 20:17 ago) – Posting: # 3694
Views: 5,279

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.

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 [Bioanalytics] 
  • 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