2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance-Reference-Cited by-同舟云学术

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

Published:2010-12 Issue:12 Volume:2 Page:1945-1960
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Savoie Natasha¹,Garofolo Fabio¹,van Amsterdam Peter²,Bansal Surendra³,Beaver Chris⁴,Bedford Patrick⁵,Booth Brian P⁶,Evans Christopher⁷,Jemal Mohammed⁸,Lefebvre Marc¹,Lopes de Silva Arthur Leonardo⁹,Lowes Steve¹⁰,Marini Joseph C¹¹,Massé Robert¹²,Mawer Louise¹³,Ormsby Eric⁵,Rocci Jr Mario L¹⁴,Viswanathan CT⁶,Wakelin-Smith Jason¹³,Welink Jan¹⁵,White Joleen T⁸,Woolf Eric¹⁶

Affiliation:

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

2. Abbott Healthcare Products BV, Weesp, Netherlands

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

4. MDS Pharma Services, QC, Canada

5. Health Canada TPD, Ottawa, ON, Canada

6. Food and Drug Administration, CDER, Silver Spring, MD, USA

7. GlaxoSmithKline, King of Prussia, PA, USA

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

9. ANVISA, Brasilia, Brazil

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

11. Centocor R&D, Inc.Johnson & Johnson, Radnor, PA, USA

12. Anapharm/PharmaNet, Quebec City, QC, Canada

13. Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

14. ICON Development Solutions, Whitesboro, NY, USA

15. Medicines Evaluation Board, The Hague, The Netherlands

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

Abstract

The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several ‘hot’ topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules.

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.10.164

Reference34 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. EMA.Draft Guideline on the Validation of Bioanalytical Methods.EMA, Committee for Proprietary Medicinal Products (CPMP), London, UK (2009).

5. ANVISA. Resolution RE no. 899, 23 May 2003. Brazilian Sanitary Surveillance Agency, Brazil (2003).

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