Gene therapy is an exciting—and relatively new—area of medicine. Treatments were first introduced in the 1970s, but after decades of methodology challenges and scientific frustration, the concept of altering genes to address “untreatable” viruses and diseases gained...
In 1993, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) published guidance entitled “S5 Detection of Toxicity to Reproduction for Medicinal Products.” The U.S. FDA interpreted the ICH guidance and...
A new 108,000-square-foot testing facility in Chengdu, China, will allow WuXi AppTec to help meet high global demand for toxicology testing in preclinical studies. The facility significantly expands WuXi AppTec’s testing capacity at a time when many customers’...
WuXi AppTec Laboratory Testing Division experts continually weigh in on emerging trends and stay updated on salient drug development topics. Here is a rundown of the industry publications featuring WuXi AppTec experts in the second half of 2021. 1. Genetic Engineering...
Preclinical toxicology testing on new molecules is essential. Researchers use toxicity tests to identify specific adverse effects related to cancer, cardiotoxicity and skin/eye irritation and sensitization. These in vitro and in vivo studies combine with accidental...
The evaluation of toxicity in a new drug is a very thorough process, so that by the end of the testing, scientists will have compiled all the necessary data to understand the full safety profile of the potential new drug. During that nonclinical evaluation, there are...
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...
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...
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...
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...
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...
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...