9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks-Reference-Cited by-同舟云学术

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks

Published:2016-03 Issue:6 Volume:8 Page:487-495
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Hayes Roger¹,LeLacheur Richard²,Dumont Isabelle³,Couerbe Philippe⁴,Safavi Afshin⁵,Islam Rafiq⁶,Pattison Colin⁷,Cape Stephanie⁸,Rocci Mario⁹,Briscoe Chad¹⁰,Cojocaru Laura¹¹,Groeber Elizabeth¹²,Silvestro Luigi¹³,Bravo Jennifer²,Shoup Ron¹⁴,Verville Manon³,Zimmer Jennifer¹⁵,Caturla Maria Cruz¹⁶,Khadang Ardeshir¹⁷,Bourdage James¹⁸,Hughes Nicola¹⁹,Fatmi Saadya²⁰,Di Donato Lorella²¹,Sheldon Curtis⁶,Keyhani Anahita²²,Satterwhite Christina²³,Yu Mathilde²⁴,Fiscella Michele²⁵,Hulse James²⁶,Lin Zhongping (John)²⁷,Garofolo Wei²⁸,Savoie Natasha²⁸,Xiao Yi Qun²⁹,Kurylak Kai²⁹,Harris Sarah³⁰,Saxena Manju³⁰,Buonarati Mike³⁰,Lévesque Ann³¹,Boudreau Nadine³¹,Lin Jenny³²,Khan Masood U³³,Ray Gene³⁴,Liu Yansheng³⁴,Xu Allan³⁵,Soni Gunjan³⁶,Ward Ian³⁷,Kingsley Clare³⁷,Ritzén Hanna³⁸,Tabler Edward³⁹,Nicholson Bob³⁹,Bennett Patrick³⁹,van de Merbel Nico⁴⁰,Karnik Shane⁴¹,Bouhajib Mohammed⁴²,Wieling Jaap⁴³,Mulvana Daniel⁴⁴,Ingelse Benno⁴⁵,Allen Mike⁴⁶,Malone Michele⁴⁷,Fang Xinping⁴⁸

Affiliation:

1. MPI Research, Mattawan, MI, USA

2. Agilux Laboratories, Worcester, MA, USA

3. Algorithme Pharma, Laval, QC, Canada

4. Atlanbio, Saint-Nazaire, France

5. BioAgilytix, Durham, NC, USA

6. Celerion, Lincoln, NB, USA

7. Charles River, Edinburgh, UK

8. Covance, Madison, WI, USA

9. ICON, Whitesboro, NY, USA

10. PRA Health Sciences, Lenexa, KS, USA

11. Tandem Labs, West Trenton, NJ, USA, currently at Covance, WestTrenton, NJ, USA

12. WIL Research, Ashland, OH, USA

13. 3S-Pharmacological Cons. & Res. GmbH, Harpstedt, Germany

14. AIT Bioscience Indianapolis, IN, USA

15. Alturas Analytics, Moscow, ID, USA

16. Anapharm Europe, Barcelona, Spain

17. Axis Clinicals, Dilworth, MN, USA

18. BASi, West Lafayette, IN, USA

19. Bioanalytical Laboratory Services, Toronto, ON, Canada

20. Biotrial Bioanalytical Services Inc., Laval, QC, Canada

21. CAPRION, Montreal, QC, Canada

22. Charles River, Senneville, QC, CAN, currently at Algorithme Pharma, Laval, QC, Canada

23. Charles River, Reno, NV, USA

24. CIRION BioPharma Research, Laval, QC, Canada

25. Covance, Chantilly, VA, USA

26. Eurofins Pharma Bioanalytics Services, St Charles, MO, USA

27. Frontage Laboratories, Inc., Exton, PA, USA

28. Global CRO Council for Bioanalysis (GCC)

29. Global CRO Council for Bioanalysis, Envigo, East Millstone, NJ, USA

30. Intertek USA, San Diego, CA, USA

31. Previously at InVentiv Health Clinical, Quebec City, QC, CAN

32. CMIC, Inc., Hoffman Estates, IL, USA

33. KCAS Bioanalytical Services, Shawnee, KS, USA, currently at Alliance Pharma, Malvern, PA, USA

34. KCAS Bioanalytical Services, Shawnee, KS, USA

35. Keystone Bioanalytical, Inc., North Wales, PA, USA

36. Lambda Therapeutic Research, Ahmedabad, India

37. LGC, Fordham, UK

38. Mercodia AB, Uppsala, Sweden

39. PPD, Richmond, VA, USA

40. PRA Health Sciences, Assen, The Netherlands

41. Pyxant Labs, Colorado Springs, CO, USA

42. Pharma Medica, Toronto, ON, Canada

43. QPS, Groningen, The Netherlands, currently at Antaeus Biopharma, Groningen, Netherlands

44. Quintiles, Ithaca, NY, USA

45. Quintiles, Oss, The Netherlands

46. Tandem Labs, Durham, NC, USA, currently at Covance, Durham, NC, USA

47. Worldwide Clinical Trials, Austin, TX, USA

48. WuXi/XBL, 107 Morgan Lane, Plainsboro, NJ, USA

Abstract

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

Publisher

Future Science Ltd

Subject

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

Link

http://www.future-science.com/doi/pdf/10.4155/bio.16.16

Reference25 articles.

1. Formation of a Global Contract Research Organization Council for Bioanalysis

2. Conference Report: The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum

3. Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover

4. Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

5. 7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

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