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Literature DB >> 11683255

Workshop on bioanalytical methods validation for macromolecules: summary report.

K J Miller¹, R R Bowsher, A Celniker, J Gibbons, S Gupta, J W Lee, S J Swanson, W C Smith, R S Weiner.

Abstract

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Year: 2001 PMID： 11683255 DOI： 10.1023/a:1013062600566

Source DB: PubMed Journal: Pharm Res ISSN： 0724-8741 Impact factor: 4.200

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21 in total

1. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

Authors: Binodh DeSilva; Wendell Smith; Russell Weiner; Marian Kelley; JoMarie Smolec; Ben Lee; Masood Khan; Richard Tacey; Howard Hill; Abbie Celniker
Journal: Pharm Res Date: 2003-11 Impact factor: 4.200

Review 2. Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling.

Authors: Wayne A Colburn; Jean W Lee
Journal: Clin Pharmacokinet Date: 2003 Impact factor: 6.447

Review 3. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.

Authors: JoMarie Smolec; Binodh DeSilva; Wendell Smith; Russell Weiner; Marian Kelly; Ben Lee; Masood Khan; Richard Tacey; Howard Hill; Abbie Celniker; Vinod Shah; Ronald Bowsher; Anthony Mire-Sluis; John W A Findlay; Mary Saltarelli; Valerie Quarmby; David Lansky; Robert Dillard; Martin Ullmann; Stephen Keller; H Thomas Karnes
Journal: Pharm Res Date: 2005-08-24 Impact factor: 4.200

7. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins.

Authors: Jean Lee; Hongjin Ma
Journal: AAPS J Date: 2007-05-25 Impact factor: 4.009

Workshop on bioanalytical methods validation for macromolecules: summary report.

1. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

Review 2. Biomarkers, validation and pharmacokinetic-pharmacodynamic modelling.

Review 3. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.

4. A total error approach for the validation of quantitative analytical methods.

5. Appropriate calibration curve fitting in ligand binding assays.

Review 6. Biomarker method validation in anticancer drug development.

7. Specificity and selectivity evaluations of ligand binding assay of protein therapeutics against concomitant drugs and related endogenous proteins.

8. Key elements of bioanalytical method validation for macromolecules.

9. Specificity and accuracy data for ligand-binding assays for macromolecules should be interpreted with caution.

Review 10. Validation of analytic methods for biomarkers used in drug development.