Drug safety assessment is a highly complex, involved and molecule-specific process, which is why most drug developers benefit from working with a testing partner. But not all CROs are created equal. Here are six characteristics to consider. Safety assessment studies –...
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...
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...
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....
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...
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...
Engaging the right partners at the right time is essential to drug developers and the success of their compound. We sat down with Grace Furman, small-molecule toxicology consultant at Paracelsus, Inc., to get her perspective on some of the most pressing challenges and...
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...
Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...
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...