The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis-Reference-Cited by-同舟云学术

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

Published:2009-04 Issue:1 Volume:1 Page:19-30
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Savoie Natasha¹,Booth Brian P²,Bradley Troy¹,Garofolo Fabio¹,Hughes Nicola C³,Hussain Saleh⁴,King S Peter⁵,Lindsay Michael⁶,Lowes Steve⁷,Ormsby Eric⁸,Phull Rupinder⁹,Rocci Jr Mario L¹⁰,Vallano Patrick T¹¹,Viau Alan⁸,Zhu Zhimeng¹²

Affiliation:

1. 1Algorithme Pharma Inc., Laval (Montreal), QC, Canada.

2. 2Food and Drug Administration, CDER, Silver Spring, MD, USA

3. 3Biovail Contract Research, Toronto, ON, Canada

4. 4Anapharm Inc., Richmond Hill, ON, Canada

5. 5Quest Pharmaceutical Services (QPS), L.L.C., Newark, DE, USA

6. 6Apotex Inc., Weston, ON, Canada

7. 7Advion BioServices Inc., Ithaca, NY, USA

8. 8Health Canada TPD, Ottawa, ON, Canada

9. 9Barr Pharmaceuticals Inc., Montvale, NJ, USA

10. 10Prevalere Life Sciences Inc., Whitesboro, NY, USA

11. 11Mylan Pharmaceuticals Inc., Morgantown, WV, USA

12. 12Pharmascience Inc., Montreal, QC, Canada

Abstract

This event was organized by the Calibration and Validation Group (a scientific nonprofit organization based in Toronto, Canada) as a 1.5-day workshop for contract research organizations and pharmaceutical companies involved in providing bioanalytical data for bioavailability, bioequivalence, pharmacokinetic and comparability studies.

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.09.11

Reference12 articles.

1. GarofoloF. Bioanalytical Method Validation. In:Analytical Method Validation and Instrument Performance Verification.Chan CC, Lee YC, Lam H, Zhang X (Eds), Hoboken: John Wiley & Sons, Inc., West Sussex, UK, Chapter 8 (2004).

2. The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation

3. US Food and Drug Administration.Draft Guidance for Industry: Bioanalytical Method Validation.US Food and Drug Administration, Rockville, MD, USA (1999).

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