Bioequivalence and Bioavailability Forum

GLP vs. Good Scientific Practice [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2009-05-16 18:49 (6250 d 04:33 ago) – Posting: # 3688
Views: 7,389

Dear NewInPK!

I guess you may be "New in PK" but also an "old salt" in bioanalytics!

Your suggestions are the best I've read in the last years! IMHO ISR for a validated method (stability and freeze-thaw given) will confirm original results in most cases. What have we gained?
I remember a statement Rudolf E. Kaiser (one of the pioneers of gas chromatography) made in the early 1980ies:

'I consider GLP death of analytical chemistry. The only way one can assess the reliablity of a result - namely applying an alternative analytical methodology - is not allowed.'

Since in most cases an alternative method is not available, it's a good idea to challenge the one we have - far beyond rubustness/rugedness...

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 PracticeHelmut 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 GCP Ohlbe 2009-05-18 10:22
            • GLP and GCP Helmut 2009-05-18 11:31