So you think your assay is robust?-Reference-Cited by-同舟云学术

So you think your assay is robust?

Published:2015-12 Issue:23 Volume:7 Page:2969-2971
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Aubry Anne-Françoise¹,Weng Naidong²

Affiliation:

1. Bristol Myers Squibb, Analytical & Bioanalytical Development, PO Box 4000, Princeton, NJ 08540-4000, USA

2. Janssen Research & Development, Pharmacokinetics, Dynamics & Metabolism, 1400 McKean Road, Spring House, PA 19477, USA

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.15.198

Reference11 articles.

1. USP 29, chapter <1225> Validation of Compendial Methods. https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1225.pdf.

2. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human use, Validation of Analytical Procedures: Methodology. ICH Q2B, Geneva, Switzerland (1996). www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073384.pdf.

3. Utilizing design of experiments to characterize assay robustness

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

5. Guidance for Industry Bioanalytical Method Validation, FDA May (2001). www.fda.gov/downloads/Drugs/Guidancecomplianceregulatoryinformation/Guidances/ucm070107.pdf.

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