2 citations · 2 across the 2 of their papers we have counts for
2 papers
stat.AP2022★ 2 cited
Extent of Safety Database in Pediatric Drug Development: Types of Assessment, Analytical Precision, and Pathway for Extrapolation through On-Target Effects
Margaret Gamalo, Yihua Zhao, Aijun Gao +5
Pediatric patients should have access to medicines that have been appropriately evaluated for safety and efficacy. Given this goal of revised labelling, the adequacy of the pediatr…
stat.ME2022
Composite Likelihoods with Bounded Weights in Extrapolation of Data
Margaret Gamalo, Yoonji Kim, Fan Zhang +1
Among many efforts to facilitate timely access to safe and effective medicines to children, increased attention has been given to extrapolation. Loosely, it is the leveraging of co…