Bioanalytical method transfer considerations of chromatographic-based assays-Reference-Cited by-同舟云学术

Bioanalytical method transfer considerations of chromatographic-based assays

Published:2016-07 Issue:13 Volume:8 Page:1409-1413
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Williard Clark V¹

Affiliation:

1. inVentiv Health, 301D College Road East, Princeton, NJ 08540, USA

Abstract

Bioanalysis is an important part of the modern drug development process. The business practice of outsourcing and transferring bioanalytical methods from laboratory to laboratory has increasingly become a crucial strategy for successful and efficient delivery of therapies to the market. This chapter discusses important considerations when transferring various types of chromatographic-based assays in today's pharmaceutical research and development environment.

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.16.34

Reference11 articles.

1. U.S. Food and Drug Administration. Guidance for industry – bioanalytical method validation. www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf.

2. U.S. Food and Drug Administration. Guidance for industry – bioanalytical method validation, Draft Revision 1. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf.

3. European Medicines Agency. Guideline on bioanalytical method validation. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.

4. MHLW. Draft guideline on bioanalytical method validation in pharmaceutical development. www.nihs.go.jp/drug/BMV/BMV_draft_130415_E.pdf.

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