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

Author:

Lowes Steve1,Jersey Jim2,Shoup Ronald3,Garofolo Fabio4,Needham Shane5,Couerbe Philippe6,Lansing Tim7,Bhatti Masood8,Sheldon Curtis9,Hayes Roger10,Islam Rafiq11,Lin Zhongping (John)12,Garofolo Wei13,Moussallie Marc14,Teixeira Leonardo de Souza15,Rocha Thais15,Jardieu Paula16,Truog James17,Lin Jenny17,Lundberg Richard18,Breau Alan19,Dilger Carmen20,Bouhajib Mohammed21,Levesque Ann22,Gagnon-Carignan Sofi22,Jenkins Rand23,Nicholson Robert23,Lin Ming Hung24,Karnik Shane25,DeMaio William26,Smith Kirk27,Cojocaru Laura28,Allen Mike29,Fatmi Saadya30,Sayyarpour Farhad31,Malone Michele32,Fang Xinping33

Affiliation:

1. Advion BioServices, Ithaca, NY, USA

2. Agilux Laboratories, Worcester, MA, USA

3. AIT Bioscience, Indianapolis, IN, USA

4. Algorithme Pharma, Laval, Quebec, Canada

5. Alturas Analytics, Moscow, ID, USA

6. Atlanbio, Saint-Nazaire, France

7. BioAgilytix Labs, Durham, NC, USA

8. BioPharma Services, Toronto, Ontario, Canada

9. Celerion, Lincoln, NE, USA

10. Cetero Research, Houston, TX, USA (presently at MPI Research, Mattawan, MI, USA)

11. EMD Millipore, St. Charles, MO, USA

12. Frontage Laboratories, Malvern, PA, USA

13. Global CRO Council for Bioanalysis (GCC).

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

15. ICF, Goiania, Brasil

16. ICON Development Solutions, Whitesboro, NY, USA

17. JCL Bioassay USA, Hoffman Estates, IL, USA

18. MEDTOX Laboratories, St Paul, MN, USA

19. MPI Research, Mattawan, MI, USA

20. Nuvisan GmbH, Neu-Ulm, Germany

21. Pharma Medica, Toronto, Ontario, Canada

22. PharmaNet Canada, Quebec City, Quebec, Canada

23. PPD, Richmond, VA, USA

24. Protech Pharmaservices, Taipei City, Taiwan

25. Pyxant Labs, CO Springs, CO, USA

26. Ricerca Biosciences, Concord, OH, USA

27. Smithers Pharma, Wareham, MA, USA

28. Tandem Labs, West Trenton, NJ, USA

29. Tandem Labs, Durham, NC, USA

30. Warnex Bioanalytical, Laval, Quebec, Canada

31. WIL Research Company, Skokie, IL, USA

32. Worldwide Clinical Trials, Austin, TX, USA

33. XenoBiotic Laboratories, Plainsboro, NJ, USA

Abstract

The Global CRO Council for Bioanalysis (GCC) was formed in September 2010. Since then, the representatives of the member companies come together periodically to openly discuss bioanalysis and the regulatory challenges unique to the outsourcing industry. The 4th GCC Closed Forum brought together experts from bioanalytical CROs to share and discuss recent issues in regulated bioanalysis, such as the impact of coadministered drugs on stability, some differences between European Medicines Agency and US FDA bioanalytical guidance documents and lessons learned following recent Untitled Letters. Recent 483s and agency findings, as well as issues on method carryover, were also part of the topics discussed.

Publisher

Future Science Ltd

Subject

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

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