Oligonucleotide drugs have become a hot topic in biomedicine due to their strong specificity, well-established design strategy, short development cycle, and wide range of targets.
Safety Assessment
3 Benefits of In Vitro ADME Testing Automation
In vitro ADME assays provide the data necessary to ensure the safety and efficacy of your drug candidates. Automating these tests can shorten the time it takes your product to reach the market.
Innovative Bioanalytical Strategies for Oligonucleotide Therapeutics: A New Frontier in American Drug Development
In the evolving landscape of drug development, oligonucleotide drugs (ONDs) stand at the forefront of innovative therapeutic solutions. As the pharmaceutical industry shifts towards addressing complex genetic disorders and resistant forms of cancer, ONDs offer a promising avenue due to their ability to precisely target and modulate gene expression.
6 Types of Toxicology Studies for IND & NDA Programs
Safety assessment studies are critical to the progression of your drug candidate through the preclinical and clinical development process. In this blog, we cover six types of studies that you might need to include.
Bridging Cultures, Breaking Barriers: WuXi AppTec Women Leading the Way in Drug Development
To begin FIH trials, researchers have to demonstrate that the compound is reasonably safe for initial use in humans with toxicity data.
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 –...
Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways
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...