With recent technological advances and availability of new data sources, we are experiencing exciting changes to the human medical product regulatory landscape. While these new areas have created challenges, they also present opportunities. This …
The crisis of opioid abuse and overdose in the United States has involved unprecedented levels of opioid prescriptions and opioid-related mortality. Greater understanding of current trends in prescription opioid utilization may help prevent new cases …
The standardization of nonclinical study data by the Clinical Data Interchange Standards Consortium (CDISC) via the Standard for Exchange of Nonclinical Data (SEND) has created an opportunity for the collaborative development and use of open source …
Research reproducibility has been heatedly discussed in recent years. Some authors have pointed out that a large portion of published research findings is incorrect and/or irreproducible. Some state that the medical literature is as reliable as …
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 …