2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines-Reference-Cited by-同舟云学术

2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

Published:2012-09 Issue:18 Volume:4 Page:2213-2226
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

DeSilva Binodh¹,Garofolo Fabio²,Rocci Mario³,Martinez Suzanne⁴,Dumont Isabelle⁴,Landry France⁴,Dicaire Catherine⁴,Szekely-Klepser Gabriella⁵,Weiner Russell⁶,Arnold Mark¹,Bansal Surendra⁷,Bateman Kevin⁸,Bauer Ronald⁹,Booth Brian¹⁰,Davis Scott¹¹,Dudal Sherri¹²,Gouty Dominique¹³,Grundy John¹⁴,Haidar Sam¹⁰,Hayes Roger¹⁵,Jemal Mohammed¹,Kaur Surinder¹⁶,Kelley Marian¹⁷,Knutsson Magnus¹⁸,Le Blaye Olivier¹⁹,Lee Jean²⁰,Lowes Steve²¹,Ma Mark²⁰,Mitsuoka Toshinari²²,Neto João Tavares²³,Nicholson Robert¹¹,Ormsby Eric²⁴,Sailstad Jeffrey²⁵,Stevenson Lauren²⁶,Tang Daniel²⁷,Welink Jan²⁸,Viswanathan CT²⁹,Wang Laixin³⁰,Woolf Eric⁸,Yang Eric³¹

Affiliation:

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

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

3. ICON Development Solutions, Whitesboro, NY, USA

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

5. Allergan, Irvine, CA, USA

6. Merck Research Laboratories, Rahway, NJ, USA

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

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

9. AGES, Vienna, Austria

10. US FDA, Center for Drug Evaluation & Research, Silver Spring, MD, USA

11. PPD, Richmond, VA, USA

12. Novartis Pharma Inc., Basel, Switzerland

13. Intertek, San Diego, CA, USA

14. Isis Pharmaceutical Inc., Carlsbad, CA, USA

15. MPI Research, Mattawan, MI, USA

16. Genentech, South San Francisco, CA, USA

17. MKelley Consulting LLC, West Chester, PA, USA

18. Ferring Pharmaceuticals, Copenhagen, Denmark

19. ANSM (formerly AFSSAPS), St-Denis, France

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

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

22. Japan MHLW-NIHS, Tokyo, Japan

23. ANVISA, Brasilia, Brazil

24. Health Canada TPD, Ottawa, ON, Canada

25. Sailstad and Associates, Durham, NC, USA

26. Biogen Idec Inc., Cambridge, MA, USA

27. ICON Development Solutions, Shanghai, China

28. Medicines Evaluation Board, Utrecht, The Netherlands

29. CT Vishwanathan & Associates, Rockville, MD, USA

30. Tandem Labs, Salt Lake City, UT, USA

31. GlaxoSmithKline, King of Prussia, PA, USA

Abstract

Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous ‘hot’ topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year’s workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.

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.12.205

Reference40 articles.

1. Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

2. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

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

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

5. 2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

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