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...
In the face of a wide-spread pandemic, something extraordinary is happening in the drug development industry – competitors are becoming collaborators and collaborations are accelerating results. WuXi AppTec’s Co-CEO, Head of RSD, Head of WuXi Testing, Steve Yang,...
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...
Protein quantitation by liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become an increasingly popular field for pharmacokinetics study in the drug discovery phase. Traditional method development using a ligand binding assay usually requires 2-3 months....
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...
In 2019, the U.S. Food and Drug Administration (FDA) revised its guidance for immunogenicity risk assessment (IRA) of biological therapies. IRA is required to help drug developers and regulatory agencies better understand the potential impact an immune response will...
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...
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 unforeseen and drastic effects the COVID-19 pandemic has had on the industry have led to unanticipated challenges, including stricter international shipping regulations, travel restrictions, local lockdowns and more. However, industry leaders are still here to...