C
C. T. Viswanathan
Researcher at Center for Drug Evaluation and Research
Publications - 13
Citations - 5222
C. T. Viswanathan is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Pharmacokinetics & Drug development. The author has an hindex of 11, co-authored 13 publications receiving 5128 citations.
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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.
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
TL;DR: 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.
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
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
TL;DR: The report presents the assessment of the major agreements and issues discussed at the conference on analytical methods validation and provides guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals.
Journal ArticleDOI
Workshop/conference report—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: The workshop identified the essential parameters for bioanalytical method validation, ie, accuracy, precision, selectivity, sensitivity, reproducibility, limit of detection, and stability, and resulted in improved quality of data submissions to regulatory agencies.