Immunogenicity assessment helps drug developers understand the possible immune responses that can occur when humans are exposed to a potential therapeutic protein. Recently, the FDA has updated its guidance for immunogenicity risk assessment for developing and...
Speed is essential for your in vitro and in vivo screening during drug discovery. Whether you are developing a small or large molecule drug, working with the right bioanalytical team is essential to your success. Look for a partner that provides comprehensive services...
Molecule tracking via preclinical testing is a significant yet necessary investment for drug developers. The stakes are high, and it's critical to stay apprised of your program's progress from start to finish. You need to monitor how your compound is progressing and...
Around the globe, drug developers are trying to understand how the pandemic will impact the progress of their molecule during preclinical testing. Depending on a testing partner's response to the pandemic, your project's status can look drastically different from one...
While much of the world continues to cancel events and defer projects in light of the COVID-19 pandemic, drug development often doesn't have the luxury of going on hold. Preclinical drug testing and the submissions that follow can't afford potential delays, which...
The recently updated guidelines on assessing drug-drug interactions will likely improve experimental outcomes, reduce costs and streamline development timelines. The U.S. FDA updated its guidelines for in vitro drug interaction assessment to help drug developers...
Between travel limits and social distancing, in-person visits at testing sites for drug and medical device development are currently not an option. Qualifying testing sites is a standard industry practice, but the resulting restrictions of COVID-19 present new...
The novel coronavirus (COVID-19) pandemic has thrown many standard procedures out the window, including how companies approach the logistics of shipping biological samples to China. To prevent the introduction and spread of infectious disease, Chinese Customs...
Meeting drug development timelines are highly important and the building blocks of success for drug development companies. Frequently, financing tranches are connected to the achievement of milestones, and potential strategic partners may be evaluating multiple...