On Nov 22nd, 2021, the R Consortium R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway. The submission package has been received by the FDA staff who were able to reproduce the numerical …
The CDISC-SEND data standard has created new opportunities for collaborative development of open-source software solutions to facilitate cross-study analyses of toxicology study data. A public private partnership between BioCelerate and FDA/CDER was …
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 …