Blog
Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways
Introducing new drug candidates to preclinical testing is a complex and time-consuming endeavor. It can cost developers more than $1 billion and take a decade to bring a new drug to market. Success rates vary depending on therapeutic area, but a recent study from MIT...
The Complex Process of Developing a Living Protocol
There are times in the laboratory when experienced scientists may question the direction in a protocol. Their experience, having worked on so many studies, may tempt them to consider conducting the testing a little differently than the directions provided to them. If...
How Bioanalytical Laboratory Automation Improves Timelines and Accuracy
It is challenging to find a fully automated bioanalytical laboratory, but doing so can help drug developers stay competitive in today’s market. A fully automated laboratory can perform controlled and error-free assays, dramatically improving the accuracy and...
Understanding Oligonucleotides and Their Bioanalytical Considerations
As new modalities in drug development gain popularity, we are in an exciting place to treat and prevent complex disease states. Researchers have been making great strides in the development of oligonucleotides, otherwise known as “oligos.” Though these therapies...
Basic Questions Developers Are Asking About In Vitro-In Vivo Extrapolation
In Vitro-In Vivo Extrapolation (IVIVE) is an emerging discipline that helps researchers predict the rate at which compounds metabolize within the human liver and are eliminated from the body (i.e., human clearance rate). Put simply, IVIVE uses in vitro methods to...
Join WuXi AppTec at the 2021 American Association of Pharmaceutical Scientists PharmSci 360
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...
Join WuXi AppTec at the 42nd American College of Toxicology Annual Meeting
WuXi AppTec is excited to exhibit at this year’s 42nd Annual Meeting of the American College of Toxicology (ACT). The event runs from November 14-17, 2021, and will be held at Gaylord National Harbor located just outside Washington D.C. The ACT Annual Meeting brings...
In The News: WuXi AppTec Experts In The Drug Development Community (Jan-July 2021)
WuXi AppTec Laboratory Testing Division experts continually weigh in on emerging trends and stay updated on salient drug development topics. These experts routinely contribute to industry publications. Here’s where they’ve been featured in the first half of 2021....
Testing Toxicity to Advance to Phase I Clinical Trials
Preclinical research teams enter each drug testing project with the same hope – that the drug will meet all the safety requirements in order to advance to phase I clinical trials in humans. In laboratory experiments, scientists will test their ideas for new...
Managing Critical Reagents: An Essential Part of Your Bioanalytical Strategy
Critical reagents are an essential part of bioanalytical testing for large molecule preclinical and clinical studies. These essential components help determine the accuracy of the analyte, precision and performance of ligand binding assays (LBAs), which are key to...
Good Communication Essential To Successful Preclinical Testing
For both large and small drug development companies, good communication displayed throughout the preclinical testing process is essential to success. Project leaders who exhibit great awareness, flexibility and communication skills can’t be undervalued in the timely...
Understanding Differences in Regulatory Requirements Vital to Efficient Design of Preclinical Programs
There are many factors involved in designing a preclinical drug safety assessment program, but among the priorities is having a good understanding of the different requirements from the various regulatory agencies in which the Investigative New Drug (IND) will be...