GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

Author:

Nehls Corey1,Buonarati Michael2,Cape Stephanie3,Islam Rafiq4,Satterwhite Christina5,Briscoe Chad6,Hayes Roger7,Dinan Andrew8,Sales Kurt8,Anderson Shelby9,Vance Jennifer9,Lindsay John10,Zimmer Jennifer11,Couerbe Philippe12,Khadang Ardeshir13,Maasjo Sarah13,Bravo Orlando14,Lindley Kathie15,Moran Liam16,Sangster Timothy17,Vija Jenifer18,Stamatopoulos John19,Lin Jenny20,Reuschel Scott21,Underberg Angie3,MacNeill Robert22,Matassa Luca23,Spytko Adriane7,Garofolo Wei24,Savoie Natasha24,Rhyne Paul25,Ambrosius Jason25,Barra Valentine2,Dufield Dawn26,Luna Marsha26,Spriggs Franklin26,Fedorov Evgueni27,Ritzén Hanna28,Fatmi Saadya29,Kane Cheikh30,Bouhajib Mohammed31,DiMarco Chantal31,Iordachescu Adriana32,Tudoroniu Ariana32,Farley Esme33,Stouffer Bruce1,Tabler Edward1,McCown Stacie6,Bower Joseph34,Harrison Travis35,Karnik Shane36,Brown Michael37,Joyce Philip38,DuBey Ira39,Hoffpauir Brian39,Boudreau Nadine40,Bergeron Jerome40,Wang Hao41,Feng Hao42,Zhou Shaolian43,Wells Edward43,Pirro John44,Fang Xinping44,Shi Jing45,Yang Changming45

Affiliation:

1. PPD Laboratories, Richmond, Virginia, USA

2. Intertek, San Diego, California, USA

3. Covance, Madison, Wisconsin, USA

4. Celerion, Lincoln, Nebraska, USA

5. Charles River Laboratories, Reno, Nevada, USA

6. PRA Health Sciences, Lenexa, Kansas, USA

7. ICON Laboratory Services, Whitesboro, New York, USA

8. Agilex Biolabs, Adelaide, Australia

9. AIT Bioscience, Indianapolis, Indiana, USA

10. Altasciences, Everett, Washington, USA

11. Alturas Analytics, Moscow, Idaho, USA

12. Atlanbio, Saint-Nazaire, France

13. Axis Clinicals, Dilworth, Minnesota, USA

14. BASi, West Lafayette, Indiana, USA

15. BioAgilytix, Durham, North Carolina, USA

16. Charles River Laboratories, Ashland, Ohio, USA

17. Charles River Laboratories, Edinburgh, UK

18. Charles River Laboratories, Skokie, Illinois, USA

19. CiToxLAB North America, Laval, Quebec, Canada

20. CMIC, Hoffman Estates, Illinois, USA

21. Covance, Salt Lake City, Utah, USA

22. Envigo, Somerset, New Jersey, USA

23. Frontage Lab, Exton, Pennsylvania, USA

24. GCC, Toronto, Ontario, Canada

25. Immunologix Laboratories, Tampa, Florida, USA

26. KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA

27. Lambda Therapeutic Research, Toronto, Ontario, Canada

28. Mercodia AB, Uppsala, Sweden

29. NEOMED-LABS, Laval, Quebec, Canada

30. Pacific Biomarkers, Seattle, Washington, USA

31. Pharma Medica Research Inc., Mississauga, Ontario, Canadian

32. Pharma Serv International, Bucharest, Romania

33. Pharmaron, Germantown, Maryland, USA

34. Precision for Medicine, Frederick, Maryland, USA

35. Precision for Medicine, Redwood City, California, USA

36. Pyxant Labs, Colorado Springs, Colorado, USA

37. Q2 Solutions, Marietta, Georgia, USA

38. Q2 Solutions, Ithaca, New York, USA

39. Smithers Avanza, Gaithersburg, Maryland, USA

40. Syneos Health, Quebec City, Quebec, Canada

41. TETRAQ, Brisbane, Australia

42. Value pharmaceutical service, Nanjing, China

43. Worldwide Clinical Trials, Austin, Texas, USA

44. WuXi Apptec, Plainsboro, New Jersey, USA

45. WuXi Apptec, Shanghai, China

Abstract

The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants from eight countries representing 44 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the ICH M10 Bioanalytical Method Validation Draft Guideline and to build unified comments to be provided to the ICH.

Publisher

Future Science Ltd

Subject

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

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