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...
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...
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...
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...
PROTACs, otherwise known as PROteolysis TArgeting Chimera, emerged as a novel therapeutic modality in drug development and currently show promising clinical results for tackling some of the most complex diseases. PROTACs are designed to leverage the body’s internal...
As our understanding of genomics and biological pathways expands, human diseases, once thought untreatable through conventional therapies, are well within our realm of intervention. Oligonucleotides ("oligos") and bispecific antibodies (BsAbs) are two new modalities...
New drug modalities, including oligonucleotides, bispecific antibodies, prodrugs, cell and gene therapies, and fusion proteins, offer new ways to treat human diseases once considered "untreatable." Cell and gene therapies have been around for years, but advancing...
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a multidisciplinary guideline that governs bioanalytical method validation. Drugs need to contain the correct...
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 use of Internal Standards (IS) is essential to Liquid Chromatography-tandem Mass Spectrometric (LC-MS/MS) quantitative bioanalytical methods. Yet, there are no set methodologies or widely adopted criteria among laboratories for establishing and assessing Internal...
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...