In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study-Reference-Cited by-同舟云学术

In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study

Published:2015-03-05 Issue:3 Volume:17 Page:684-690
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Thway Theingi M.,Macaraeg Chris,Eschenberg Michael,Ma Mark

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-015-9741-9.pdf

Reference4 articles.

1. Wang D et al. Clinical trials a practical guide to design, analysis and reportings. Chapter 13 bioequivalence trials.

2. DeSilva B et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20:1885–900.

3. Thway TM et al. Applications of a planar electrochemiluminesce platform to support regulated studies of macromolecules: benefits and limitations in assay range. J Pharm Biomed Anal. 2010;51:626–32.

4. Van Peer A. Variability and impact on design of bioequivalence studies. Basic Clin Pharmacol Toxicol. 2010;106:146–53.

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