2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections-Reference-Cited by-同舟云学术

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Published:2011-09 Issue:18 Volume:3 Page:2081-2096
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Garofolo Fabio,Rocci Mario L¹,Dumont Isabelle²,Martinez Suzanne²,Lowes Steve³,Woolf Eric⁴,van Amsterdam Peter⁵,Bansal Surendra⁶,Barra Ariadna Cristina Gomes⁷,Bauer Ronald⁸,Booth Brian P⁹,Carrasco-Triguero Montserrat¹⁰,DeSilva Binodh¹¹,Dunn John¹²,Gallicano Keith¹³,Gouty Dominique¹⁴,Ho Stacy¹⁵,Hucker Richard¹⁶,Jemal Mohammed¹¹,Katori Noriko¹⁷,Le Blaye Olivier¹⁸,Lee Jean¹⁹,Li Wenkui²⁰,Michael Steve²¹,Nehls Corey²²,Nicholson Robert²³,Ormsby Eric²⁴,Tang Daniel²⁵,Viswanathan CT⁹,Weiner Russell²⁶,Young Graeme²⁷

Affiliation:

1. ICON Development Solutions, Whitesboro, NY, USA

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

3. Advion BioServices Inc., Ithaca, NY, USA

4. Merck Research Laboratories, West Point, PA, USA

5. Abbott Healthcare Products BV, Weesp, The Netherlands

6. Hoffmann-La Roche, Nutley, NJ, USA

7. ANVISA, Brasilia, Brazil

8. AGES PharmMed, Vienna, Austria

9. US FDA, CDER, Silver Spring, MD, USA

10. Genentech, South San Francisco, CA, USA

11. Bristol-Myers Squibb, Princeton, NJ, USA

12. GlaxoSmithKline Research & Development, RTP, NC, USA

13. Watson Laboratories, Corona, CA, USA

14. Intertek, San Diego, CA, USA

15. Genzyme Corporation, Waltham, MA, USA

16. Pfizer, Sandwich, UK

17. Japan MHLW-NIHS, Tokyo, Japan

18. AFSSAPS, St-Denis, France

19. Amgen Inc., Thousand Oaks, CA, USA

20. Novartis Institutes for Biomedical Research, East Hanover, NJ, USA

21. Covance, Madison, WI, USA

22. PPD, Middleton, WI, USA

23. PPD, Richmond, VA, USA

24. Health Canada TPD, Ottawa, ON, Canada

25. Frontage Laboratories, Shanghai, China

26. Merck Research Laboratories, Rahway, NJ, USA

27. GlaxoSmithKline Research & Development, Ware, UK

Abstract

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many ‘hot’ topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

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.11.192

Reference22 articles.

1. Society Spotlight: Spotlight on the Calibration and Validation Group

2. The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

3. 2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

4. 2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

5. Special Focus Issue: Dried Blood Spots.Bioanalysis2(11),(2010).

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