Determination of bioequivalence (BE), a crucial part of the evaluation of generic drugs, may depend on clinical endpoint studies, pharmacokinetic (PK) studies of bioavailability, and In-Vitro tests, among others. Additionally, in reviewing …
When it comes to analytics of data collected in medical research, today’s culture is compartmentalized – not only across institutions, but even within institutions. Such a culture stagnates analytical development and limits the ability to fully …
Lilliam will be presenting a perspective on what the office of computational science is doing to support regulatory review for safety assessments. She will explore the concept of collaborations and sharing to support process and transparency, along …
The United States Food and Drug Administration (FDA) uses a variety of statistical software packages for review and research. This presentation will focus on the uses of R in the Center for Drug Evaluation and Research (CDER), including graphics for …