DMPK - A Key Step, Every Step of the Way Drug metabolism and pharmacokinetics (DMPK) is a crucial component in the success of your drug development – at every stage, from discovery to preclinical to clinical. DMPK studies set basic expectations of drug behavior, which...
Explore our New Jersey facilities from wherever you are working, even the comfort of your own home. Virtually tour our New Jersey facilities in Cranbury and Plainsboro to learn about our Bioanalytical and DMPK capabilities and instrumentation to support your drug...
Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...
One of the largest shares of preclinical testing in any drug development program is toxicology studies, yet bringing together the community supporting this pivotal development stage does not happen often enough. Fortunately, the 2020 American College of Toxicology...
Many drug development companies are prepared to move their programs forward and effectively submit preclinical packages to regulatory bodies. In the challenging business of drug development, disruptions and obstacles are elements that must be part of the conversation...
In vivo studies, such as pharmacokinetics (PK) and absorption, distribution, metabolism and excretion (ADME), are critical to your compound’s vitality as you prepare for regulatory submission. Knowing when these studies should be completed can often be a pressure...
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...
For drug developers ready to progress a molecule to the pivotal clinical trial stage, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) is a significant milestone. Drug developers approach this task with a wide range...
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...