WuXi AppTec is looking forward to this year's American Association of Pharmaceutical Scientists (AAPS) annual meeting—known as "PharmSci 360"—on Oct. 17-20. PharmSci 360 is being held at the Pennsylvania Convention Center located in Philadelphia's Center City...
IND Application
Regulatory Pathways: IND Requirement Variations Between U.S. FDA, OECD and NMPA
The development path for bringing new drugs and therapeutics to market requires extensive planning to meet the short- and long-term needs of products intended for global registration. Because international regulatory agencies may have different requirements for...
Ensure a Successful Clinical Translation with DMPK Strategies
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...
New U.S. FDA DDI Draft Guidance for Therapeutic Proteins
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...
ACT Annual Meeting: Managing Roadblocks to Success
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...
Ramp Up: What Drug Developers Need to Know
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 the News: The IND Application, Timelines & Advice for Small Drug Developers
Recently our WuXi AppTec subject matter experts contributed to notable publications. Below is a quick recap of where to find them sharing their knowledge, advice and passion for drug development. Pharma Manufacturing Keys to Submitting a Successful IND Application to...
Partnerships that Prioritize the Customers
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...
What You Need To Know Planning for an IND Submission
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...