European Bioanalysis Forum and the way forward towards harmonized regulations-Reference-Cited by-同舟云学术

European Bioanalysis Forum and the way forward towards harmonized regulations

Published:2009-08 Issue:5 Volume:1 Page:873-875
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Lausecker Berthold¹,van Amsterdam Peter²,Brudny-Kloeppel Margarete³,Luedtke Silke⁴,Timmerman Philip⁵

Affiliation:

1. F. Hoffmann-La Roche, Pharmaceuticals Division, Non-Clinical Safety, DMPK, Bioanalysis, PO Box, Basel, CH-4070, Switzerland.

2. Solvay Pharmaceuticals

3. Bayer Schering Pharma AG

4. Boehringer-Ingelheim

5. Johnson & Johnson

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.09.96

Reference16 articles.

1. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

2. US FDA.Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, USA (2001).

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

4. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

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