scholarly journals The Role of the Food and Drug Administration in Drug Development: On the Subject of Proarrhythmia Risk

2020 ◽  
Vol 11 (1) ◽  
pp. 3958-3967
Author(s):  
Munveer Thind ◽  
Peter Kowey
Keyword(s):  
Drug Development ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
The Subject

scholarly journals Poly-ADP-ribose polymerase inhibitor use in ovarian cancer: expanding indications and novel combination strategies

2019 ◽  
Vol 29 (5) ◽  
pp. 956-968 ◽  
Author(s):  
Emily Hinchcliff ◽  
Shannon Neville Westin ◽  
Graziela Dal Molin ◽  
Christopher J LaFargue ◽  
Robert L. Coleman
Keyword(s):  
Ovarian Cancer ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Parp Inhibitors ◽  
Parp Inhibition ◽  
Combination Therapies ◽  
Combination Strategies ◽  
Polymerase Inhibitor

The use of poly(ADP-ribose) polymerase (PARP) inhibition is transforming care for the treatment of ovarian cancer, with three different PARP inhibitors (PARPi) gaining US Food and Drug Administration approval since 2014. Given the rapidly expanding use of PARPi, this review aims to summarize the key evidence for their use and therapeutic indications. Furthermore, we provide an overview of the development of PARPi resistance and the emerging role of PARPi combination therapies, including those with anti-angiogenic and immunotherapeutic agents.

scholarly journals Predicting Mortality with Applied Machine Learning: Can We Get There?

2019 ◽  
Vol 8 (1) ◽  
pp. 115-119
Author(s):  
Emily S. Patterson ◽  
C.J. Hansen ◽  
Theodore T. Allen ◽  
Qiwei Yang ◽  
Susan D. Moffatt-Bruce
Keyword(s):  
Machine Learning ◽  
Decision Making ◽  
Real Time ◽  
Drug Administration ◽  
Patient Population ◽  
Food And Drug Administration ◽  
Hospital Environment ◽  
Clinical Settings ◽  
Applied Machine Learning

There is growing interest in using AI-based algorithms to support clinician decision-making. An important consideration is how transparent complex algorithms can be for predictions, particularly with respect to imminent mortality in a hospital environment. Understanding the basis of predictions, the process used to generate models and recommendations, how to generalize models based on one patient population to another, and the role of oversight organizations such as the Food and Drug Administration are important topics. In this paper, we debate opposing positions regarding whether these algorithms are ‘ready yet’ for use today in clinical settings for physicians, patients and caregivers. We report voting results from participating audience members in attendance at the conference debate for each of these positions obtained real-time from a smartphone-based platform.

Sign in / Sign up

Export Citation Format

Share Document