Results for 'Cardiac safety'
Jonathan H Seltzer MD, MBA, MA, Gary Gintant PhD, Laleh Amiri-Kordestani MD, Jack Singer MD, Luana Pesco Koplowitz MD, PhD, Javid J Moslehi MD, Ana Barac MD, PhD, Anthony F. Yu MD
Assessing cardiac safety in oncology drug development
Cardiac safety, cardiovascular, FDA, CSRC
The Cardiac Safety Research Consortium (CSRC) highlighted the importance of addressing cardiovascular (CV) adverse effects in oncology drug development during a Think Tank meeting in October 2017. With over 1,600 cancer therapies in development, the cardiovascular toxicity of cancer treatments has b…
Jun 12th • 12 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
biologics, external validity, FDA, biosimilars, trastuzumab
Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…
Apr 6th • 2 mins read