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...
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 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...
Encountering challenges while developing a new drug is expected, but drug developers who understand the pitfalls are often better prepared to navigate them and emerge successfully. Nonclinical safety assessment is a highly complex and molecule-specific process, but...
Metabolites in safety testing (MIST) has become an integrated part of drug metabolism research in drug development, and is a widely discussed topic within the drug development industry. Recent guidance from the U.S. Food and Drug Administration (FDA) on safety...
Recent guidance from the U.S. Food and Drug Administration (FDA) on Safety Testing of Drug Metabolites helps drug developers know when and how to identify and characterize drug metabolites. Identifying and characterizing a drug's metabolic profile is a necessary step...
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...
Explore our New Jersey facilities from wherever you are working, even the comfort of your own home. Virtually tour our New Jersey facilities in Cranbury and Plainsboro to learn about our Bioanalytical and DMPK capabilities and instrumentation to support your drug...
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...
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...