Bioanalytical method validation: a risk-based approach?-Reference-Cited by-同舟云学术

Bioanalytical method validation: a risk-based approach?

Published:2004-06 Issue:4 Volume:35 Page:887-893
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

James C.A.,Breda M.,Frigerio E.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference30 articles.

1. Guidance for Industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, CDER, Rockville, USA, May 2001.

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

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