Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

Author:

Lowes Steve1,Jersey Jim2,Shoup Ronald3,Garofolo Fabio4,Savoie Natasha4,Mortz Ejvind5,Needham Shane6,Caturla Maria Cruz7,Steffen Ray8,Sheldon Curtis9,Hayes Roger10,Samuels Tim11,Di Donato Lorella12,Kamerud John13,Michael Steve14,Lin Zhongping (John)15,Hillier Jim16,Moussallie Marc17,de Souza Teixeira Leonardo18,Rocci Mario19,Buonarati Mike20,Truog James21,Hussain Saleh22,Lundberg Richard23,Breau Alan24,Zhang Tianyi24,Jonker Jianine25,Berger Neil26,Gagnon-Carignan Sofi27,Nehls Corey28,Nicholson Robert29,Hilhorst Martijn30,Karnik Shane31,de Boer Theo32,Houghton Richard33,Smith Kirk34,Cojocaru Laura35,Allen Mike36,Harter Tammy37,Fatmi Saadya38,Sayyarpour Farhad39,Vija Jenifer40,Malone Michele41,Heller Dennis42

Affiliation:

1. Advion BioServices, Ithaca, NY, USA

2. Agilux Laboratories, Worcester, MA, USA

3. AIT Bioscience, Indianapolis, IN, USA

4. Algorithme Pharma Inc., Quebec, Canada; Algorithme Pharma Inc., 575 Armand-Frappier Blvd, Laval (Montreal) Quebec, H7V 4B3, Canada.

5. Alphalyse, Odense, Denmark

6. Alturas Analytics, Moscow, ID, USA

7. Anapharm Europe, Barcelona, Spain

8. BASi, West Lafayette, IN, USA

9. Celerion, Lincoln, NB, USA

10. Cetero Research, Houston, TX, USA

11. Charles River, Senneville, Quebec, Canada

12. CIRION BioPharma Research, Laval, Quebec, Canada

13. Covance, Chantilly, VA, USA

14. Covance, Madison, WI, USA

15. Frontage Laboratories, Malvern, PA, USA

16. Gen-Probe Life Sciences, Manchester, UK

17. Huntingdon Life Sciences, East Millstone, NJ, USA

18. ICF, Goiania, Brasil

19. ICON Development Solutions, Whitesboro, NY, USA

20. Intertek, El Dorado Hills, CA, USA

21. JCL BIoassay USA, Hoffman Estates, IL, USA

22. Lambda Therapeutic Research, Toronto, ON, Canada

23. MEDTOX Laboratories, St Paul, MN, USA

24. MPI Research, Mattawan, MI, USA

25. Parexel, Bloemfontein, South Africa

26. Pharma Medica, Toronto, ON, Canada

27. PharmaNet Canada, Quebec City, Quebec, Canada

28. PPD, Middleton, WI, USA

29. PPD, Richmond, VA, USA

30. PRA International, Lenexa, KS, USA

31. Pyxant Labs, Colorado Springs, CO, USA

32. QPS, Groningen, Netherlands

33. Quotient Bioresearch, Fordham, UK

34. Smithers Pharma, Wareham, MA, USA

35. Tandem Labs, West Trenton, NJ, USA

36. Tandem Labs, Durham, NC, USA

37. Unilab York Bioanalytical Solutions, York, UK

38. Warnex Bioanalytical, Laval, Quebec, Canada

39. WIL Research Company, Ashland, OH, USA

40. WIL Research Company, Skokie, IL, USA

41. Worldwide Clinical Trials, Austin, TX, USA

42. XenoBiotic Laboratories, Plainsboro, NJ, USA

Abstract

“The Global CRO Council (GCC) for Bioanalysis was formed in an effort to bring together many CRO leaders to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry”

Publisher

Future Science Ltd

Subject

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

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