To begin FIH trials, researchers have to demonstrate that the compound is reasonably safe for initial use in humans with toxicity data.
IND
Innovations in Drug Development: The Increased Utility of In Vitro Testing
In vitro assays have become an essential part of the drug development process. In vivo testing has always been limited by the translational gap between laboratory data and a drug’s eventual effect on humans. It’s not as commonly considered, but in vitro studies suffer from a similar chasm.
SOT’s 2024 Annual Meeting: Showcasing Scientific Advancement & Celebrating Milestones
In Salt Lake City’s bustling Salt Palace Convention Center, a significant event in the toxicology world is scheduled to begin on March 10.
Is Your Drug Ready for Preclinical Toxicological Testing?
Preclinical toxicological testing is a critical early milestone in drug development, acting as a gateway to clinical trials.
What Toxicity Data Is Needed Before First-In-Human (FIH) Trials?
To begin FIH trials, researchers have to demonstrate that the compound is reasonably safe for initial use in humans with toxicity data.
Advanced CCIT Methods: How CO2 Headspace Analysis is Contributing to Safer Products
Discover the importance of CCIT in biopharma for ensuring drug safety, FDA compliance and the integrity of life-saving medications.
6 Essential Qualities in a Drug Safety Assessment Testing Partner
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 –...
What Is IND-Enabling Testing & What Does It Include?
IND-enabling testing is a cornerstone of the drug development process, helping researchers predict safety concerns and estimate safe and efficacious starting doses for clinical trials. Planning ahead, understanding the tests you need to conduct, and diligent tracking...
Preparing Drug Developers for Developmental and Reproductive (DART) Studies
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...
WuXi AppTec Expands Toxicology Footprint, Capabilities with New Chengdu Facility
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’...
In The News: WuXi AppTec Experts in the Drug Development Community (Aug-Dec 2021)
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...
Q&A: How Preclinical Toxicology Contributes to Successful IND Applications
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...