C. T. Viswanathan

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.

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.

TL;DR: In general, the 3rd AAPS/FDA Bioanalytical Workshop provided a forum to discuss and clarify regulatory concerns regarding bioanalytical method validation issues.

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.

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.