Rabindra Patnaik

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: FDA's recommendations for drug sponsors who intend to establish bioavailability and/or demonstrate bioequivalence for their pharmaceutical products during the developmental process or after approval are provided.

TL;DR: The main conclusion is that the choice of a measure should be based on simulations of the particular situation in a bioequivalence trials, and all of the rate measures tested showed a degree of insensitivity to changes in rate and no universally superior measure was found.

TL;DR: The most important consideration for individual bioequivalence rests on the assurance that products deemed bioequivalent can be used interchangeably in the target population (switchability) and the proposed criterion rewards manufacture of less variable drug products and allows scaling criteria for highly variable/narrow therapeutic range drugs.