FDA Grant: Boost Your Drug Development with $500K+
Posted: April 1, 2016
This grant closed on Jun 03, 2016. We have found similar active grants for you below.
Summary
This FDA grant is for companies involved in bioequivalence studies for generic drugs. The funding supports research into advanced methods for identifying and understanding unusual data points, ultimately helping to ensure the quality and performance of your products.
Eligibility
Full Description
Aberrant observations in a bioequivalence study with pharmacokinetic endpoints may impact the estimation of residual variability, within-subject variability of the test and reference products, and potentially the bioequivalence conclusion. The purpose of this study is to evaluate and compare different quantitative methods for their capability in defining aberrant observations in bioequivalence studies with different study design features. Study results will advance regulatory science by improving the detection and understanding of aberrant observations and may help generic companies to evaluate the quality and in vivo performance of their proposed products.