Journal ArticleDOI
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Vinod P. Shah,Kamal K. Midha,Shrikant Dighe,Iain J. McGilveray,Jerome P. Skelly,Avraham Yacobi,Thomas Layloff,C. T. Viswanathan,C. Edgar Cook,R. D. McDowall,Kenneth A. Pittman,Sidney Spector +11 more
TLDR
The report presents the assessment of the major agreements and issues discussed at the conference onAnalytical Methods Validation to provide guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals.About:
This article is published in Journal of Pharmaceutical Sciences.The article was published on 1992-03-01. It has received 1220 citations till now. The article focuses on the topics: Bioequivalence.read more
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Journal ArticleDOI
Bioanalytical method validation--a revisit with a decade of progress.
Vinod P. Shah,Kamal K. Midha,John W. A. Findlay,Howard Hill,James D. Hulse,Iain J. McGilveray,Gordon McKay,Krys J. Miller,Rabindra Patnaik,Mark L. Powell,Alfred P. Tonelli,C. T. Viswanathan,Avraham Yacobi +12 more
TL;DR: The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop.
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Validation of new methods.
TL;DR: Important considerations in analytical method validation will be discussed and may be used as guidance by scientists wishing to develop and validate analytical methods.
Journal ArticleDOI
Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
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 +9 more
TL;DR: In general, the 3rd AAPS/FDA Bioanalytical Workshop provided a forum to discuss and clarify regulatory concerns regarding bioanalytical method validation issues.
Journal ArticleDOI
Fit-for-purpose method development and validation for successful biomarker measurement.
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 M. Sailstad,Masood Khan,Chad Ray,John A. Wagner +16 more
TL;DR: A practical, iterative, “fit-for-purpose” approach to biomarker method development and validation is proposed, keeping in mind the intended use of the data and the attendant regulatory requirements associated with that use, allowing increased use of biomarkers in drug development.
Journal ArticleDOI
Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Binodh DeSilva,Wendell C. Smith,Russell Weiner,Marian Kelley,JoMarie Smolec,Ben Lee,Masood Khan,Richard Tacey,Howard Hill,Abbie Celniker +9 more
TL;DR: Recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules are made.