Literature DB >> 16132353

Bioanalytical method validation for macromolecules in support of pharmacokinetic studies.

JoMarie Smolec1, 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.   

Abstract

The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.

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Year:  2005        PMID: 16132353     DOI: 10.1007/s11095-005-5917-9

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


  2 in total

1.  Workshop on bioanalytical methods validation for macromolecules: summary report.

Authors:  K J Miller; R R Bowsher; A Celniker; J Gibbons; S Gupta; J W Lee; S J Swanson; W C Smith; R S Weiner
Journal:  Pharm Res       Date:  2001-09       Impact factor: 4.200

2.  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

  2 in total
  15 in total

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

Authors:  David Hoffman; Robert Kringle
Journal:  Pharm Res       Date:  2007-03-21       Impact factor: 4.200

Review 2.  Biomarker method validation in anticancer drug development.

Authors:  J Cummings; T H Ward; A Greystoke; M Ranson; C Dive
Journal:  Br J Pharmacol       Date:  2007-09-17       Impact factor: 8.739

3.  Critical ligand binding reagent preparation/selection: when specificity depends on reagents.

Authors:  Bonita Rup; Denise O'Hara
Journal:  AAPS J       Date:  2007-05-11       Impact factor: 4.009

Review 4.  Assay formats: Recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.

Authors:  Sherri Dudal; Daniel Baltrukonis; Rebecca Crisino; M Jaya Goyal; Alison Joyce; Karolina Osterlund; John Smeraglia; Yoshitaka Taniguchi; Jihong Yang
Journal:  AAPS J       Date:  2013-12-17       Impact factor: 4.009

Review 5.  A white paper--consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements.

Authors:  J M Sailstad; L Amaravadi; A Clements-Egan; B Gorovits; H A Myler; R C Pillutla; S Pursuhothama; M Putman; M K Rose; K Sonehara; L Tang; J T Wustner
Journal:  AAPS J       Date:  2014-03-29       Impact factor: 4.009

6.  Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligand-binding assay to support pharmacokinetic assessments.

Authors:  Joseph C Marini; Michael Anderson; Xiao-Yan Cai; John Chappell; Todd Coffey; Dominique Gouty; Aparna Kasinath; Vera Koppenburg; Philip Oldfield; Shannon Rebarchak; Ronald R Bowsher
Journal:  AAPS J       Date:  2014-10-03       Impact factor: 4.009

7.  Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.

Authors:  Mitra Azadeh; Boris Gorovits; John Kamerud; Stephen MacMannis; Afshin Safavi; Jeffrey Sailstad; Perceval Sondag
Journal:  AAPS J       Date:  2017-12-27       Impact factor: 4.009

Review 8.  Validation of analytic methods for biomarkers used in drug development.

Authors:  Cindy H Chau; Olivier Rixe; Howard McLeod; William D Figg
Journal:  Clin Cancer Res       Date:  2008-10-01       Impact factor: 12.531

9.  Validated sandwich ELISA for the quantification of von Willebrand factor in rabbit plasma.

Authors:  Brendon W Smith; Jana Strakova; Jennifer L King; John W Erdman; William D O'Brien
Journal:  Biomark Insights       Date:  2010-11-28

10.  Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist.

Authors:  Timothy Wyant; Alan Lackey; Marie Green
Journal:  J Transl Med       Date:  2008-12-01       Impact factor: 5.531

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