Towards harmonized regulations for bioanalysis: moving forward!-Reference-Cited by-同舟云学术

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Towards harmonized regulations for bioanalysis: moving forward!

Published:2010-04 Issue:4 Volume:2 Page:689-691
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

van Amsterdam Peter¹,Lausecker Berthold²,Luedtke Silke³,Timmerman Philip⁴,Brudny-Kloeppel Margarete⁵

Affiliation:

1. Abbott Healthcare Products B.V.

2. F Hoffmann-La Roche.

3. Boehringer-Ingelheim.

4. Johnson & Johnson.

5. Bayer Schering Pharma AG.

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.10.37

Reference13 articles.

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

2. Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

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

4. Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum

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

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1. Verification of quantitative analytical methods in medical laboratories;Journal of Medical Biochemistry;2021

2. Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team;The AAPS Journal;2014-10-02

3. Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team;The AAPS Journal;2014-09-05

4. Bioanalytical method validation and bioanalysis in regulated settings;Specification of Drug Substances and Products;2014

5. The European Bioanalysis Forum community’s evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation;Bioanalysis;2013-03

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