Literature DB >> 18633714

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

John W A Findlay.   

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Year:  2008        PMID: 18633714      PMCID: PMC2761695          DOI: 10.1208/s12248-008-9047-2

Source DB:  PubMed          Journal:  AAPS J        ISSN: 1550-7416            Impact factor:   4.009


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  10 in total

1.  Bioanalytical method validation--a revisit with a decade of progress.

Authors:  V P Shah; K K Midha; J W Findlay; H M Hill; J D Hulse; I J McGilveray; G McKay; K J Miller; R N Patnaik; M L Powell; A Tonelli; C T Viswanathan; A Yacobi
Journal:  Pharm Res       Date:  2000-12       Impact factor: 4.200

2.  Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.

Authors:  J W Findlay; W C Smith; J W Lee; G D Nordblom; I Das; B S DeSilva; M N Khan; R R Bowsher
Journal:  J Pharm Biomed Anal       Date:  2000-01       Impact factor: 3.935

3.  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

4.  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 5.  The role of pharmacokinetics in the development of biotechnologically derived agents.

Authors:  R J Wills; B L Ferraiolo
Journal:  Clin Pharmacokinet       Date:  1992-12       Impact factor: 6.447

6.  Fit-for-purpose method development and validation for successful biomarker measurement.

Authors:  Jean W Lee; Viswanath Devanarayan; Yu Chen Barrett; Russell Weiner; John Allinson; Scott Fountain; Stephen Keller; Ira Weinryb; Marie Green; Larry Duan; James A Rogers; Robert Millham; Peter J O'Brien; Jeff Sailstad; Masood Khan; Chad Ray; John A Wagner
Journal:  Pharm Res       Date:  2006-01-12       Impact factor: 4.200

7.  Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Authors:  C T Viswanathan; Surendra Bansal; Brian Booth; Anthony J DeStefano; Mark J Rose; Jeffrey Sailstad; Vinod P Shah; Jerome P Skelly; Patrick G Swann; Russell Weiner
Journal:  Pharm Res       Date:  2007-04-26       Impact factor: 4.200

8.  Evaluation of a peptide ELISA for the detection of rituximab in serum.

Authors:  H Blasco; G Lalmanach; E Godat; M C Maurel; S Canepa; M Belghazi; G Paintaud; D Degenne; E Chatelut; G Cartron; C Le Guellec
Journal:  J Immunol Methods       Date:  2007-07-17       Impact factor: 2.303

Review 9.  Confirmatory reanalysis of incurred bioanalytical samples.

Authors:  Mario L Rocci; Viswanath Devanarayan; David B Haughey; Paula Jardieu
Journal:  AAPS J       Date:  2007-10-05       Impact factor: 4.009

10.  Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report.

Authors:  Jean W Lee; Russ S Weiner; Jeff M Sailstad; Ronald R Bowsher; Dean W Knuth; Peter J O'Brien; Jean L Fourcroy; Rakesh Dixit; Lini Pandite; Robert G Pietrusko; Holly D Soares; Valerie Quarmby; Ole L Vesterqvist; David M Potter; James L Witliff; Herbert A Fritche; Timothy O'Leary; Lorah Perlee; Sunil Kadam; John A Wagner
Journal:  Pharm Res       Date:  2005-04-07       Impact factor: 4.200

  10 in total
  3 in total

Review 1.  Ligand-Binding Assay Development: What Do You Want to Measure Versus What You Are Measuring?

Authors:  Andrew P Mayer; Charles S Hottenstein
Journal:  AAPS J       Date:  2015-12-15       Impact factor: 4.009

Review 2.  Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs.

Authors:  J Cummings; F Raynaud; L Jones; R Sugar; C Dive
Journal:  Br J Cancer       Date:  2010-10-05       Impact factor: 7.640

3.  Evaluation of cell death mechanisms induced by the vascular disrupting agent OXi4503 during a phase I clinical trial.

Authors:  J Cummings; M Zweifel; N Smith; P Ross; J Peters; G Rustin; P Price; M R Middleton; T Ward; C Dive
Journal:  Br J Cancer       Date:  2012-04-26       Impact factor: 7.640

  3 in total

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