Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum

Author:

Timmerman Philip1,Luedtke Silke2,van Amsterdam Peter3,Brudny-Kloeppel Margarete4,Lausecker Berthold5,Fischmann Stephanie6,Globig Susanne7,Sennbro Carl-Johan8,Jansat Josep M9,Mulder Hans10,Thomas Elizabeth11,Knutsson Magnus12,Kasel Dirk13,White Stephen A14,Kall Morten Anders15,Mokrzycki-Issartel Nathalie16,Freisleben Achim17,Romero Fernando18,Andersen Michael Pilgård19,Knebel Norbert20,de Zwart Marcel21,Laakso Sirpa22,Hucker Richard S23,Schmidt Dietmar24,Gordon Ben25,Abbott Richard26,Boulanger Pierre27

Affiliation:

1. Johnson & Johnson, Turnhoutseweg 30, B-2340 Beerse, Belgium.

2. Boehringer-Ingelheim

3. Solvay Pharmaceutical

4. Bayer Schering Pharma AG

5. F. Hoffmann-La Roche

6. Abbott

7. Actelion Pharmaceuticals Ltd

8. Active Biotech

9. Laboratorios Almirall SA

10. Astellas

11. AstraZeneca

12. Ferring Pharmaceuticals

13. Grünenthal GmbH

14. Glaxo SmithKline

15. H Lundbeck A/S

16. Merck&Co

17. Merck Serono

18. Novartis Pharma AG

19. Novo Nordisk

20. Nycomed

21. Schering-Plough

22. Orion Corporation Orion Pharma

23. Pfizer

24. Sanofi-Aventis

25. Servier

26. Shire Pharmaceuticals

27. UCB Pharma

Abstract

Following intensive discussions, review, alignment of procedures and multiple surveys among their member companies, the European Bioanalysis Forum (EBF) is providing a recommendation on how to integrate incurred sample reproducibility (ISR) in the bioanalytical process. The recommendation aims to provide guidance throughout the lifecycle of a validated method, including the application of the method in study support. In its recommendation, the EBF considers both the internal discussions with EBF member companies, as well as the input provided in international meetings where ISR was discussed. The ultimate goal of the EBF recommendation is to ensure that bioanalytical methods can provide accurate and reproducible concentration data for pharmacokinetic and/or toxicokinetic evaluation, without any compromise, while safeguarding the optimal use of laboratory resources.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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