A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development-Reference-Cited by-同舟云学术

A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development

Published:2009-07-22 Issue:3 Volume:11 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Tatarewicz Suzanna,Moxness Michael,Weeraratne Dohan,Zhou Lei,Hale Michael,Swanson Steven J.,Chirmule Narendra

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-009-9130-3.pdf

Reference10 articles.

1. Benson C. Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices. www.fda.gov ; 2008.

2. Bland X, Altman X. Statistical methods for assessing agreement between two methods for clinical measurement. Lancet. 1986;8:307–10.

3. de Fontenay G. Analytical method transfer: new descriptive approach for acceptance criteria definition. J Pharm Biomed Anal. 2008;46:104–12.

4. FDA. Question to the Sponsor. http://www.fda.gov/CbER/products/pentacel/pentacel060707L.htm ; 2007.

5. Lin L. Assay validation using the concordance correlation coefficient. Biometrics. 1992;48:599–604.

Cited by 7 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method;The AAPS Journal;2024-04-18

2. Best practice recommendations for the transfer of cell-based assays for the measurement of neutralizing anti-drug antibodies;Bioanalysis;2016-09

3. Enhancing efficiency and quality of statistical estimation of immunogenicity assay cut points through standardization and automation;Journal of Immunological Methods;2015-10

4. Critical reagent stability for immunogenicity assays;Immunogenicity Assay Development, Validation and Implementation;2013-11

5. Ligand-Binding Assays;Encyclopedia of Drug Metabolism and Interactions;2012-05-15