To begin FIH trials, researchers have to demonstrate that the compound is reasonably safe for initial use in humans with toxicity data.
Preclinical Safety
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.
Striking the Right Balance: Linker Design in ADC Cancer Therapies
Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
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.
ELISpot Assays: The Key to Unlocking Advanced Cellular Immunity Testing
Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
The Crucial Role of Biomarkers in the Precision Medicine Revolution
Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
Acute Toxicity Studies: 3 Best Practices to Stay on Track with Your IND Timeline
Single dose acute toxicity studies are small, relatively inexpensive studies – but critical to the success of your drug development program.
3 Common Missteps in Nonclinical Safety Assessment Testing
Safety assessment testing is one of the most involved and complex pieces of an already time-intensive and costly drug development process. Any missteps here can have drastic implications on the rest of your development program. Here are three common pitfalls to avoid....
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...