FDA

Challenges in an Evolving Regulatory Landscape: How Statisticians Can Contribute

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 …

geoMapr: A Shiny Application for Enriched Analysis of Drug Utilization Data

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 …

Simulations, and Complex Innovative Trial Designs

Interactive Visualization of Standardized CDISC-SEND-Formatted Toxicology Study Data Using R Shiny

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 …

The use of R for improved reproducibility of biomarker detection in liquid biopsies

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 …

Using R for Generic Drug Evaluation and SABE R-package for Assessing Bioequivalence of Topical Dermatological Products

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 …

Unification in a Compartmentalized Culture

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 …

Modernizing the new drug regulatory program in FDA/CDER: Can Collaborations and Sharing Help?

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 …

Using R in a regulatory environment: some FDA perspectives

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 …