Regulatory

6 Essential Qualities in a Drug Safety Assessment Testing Partner

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?  

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...

The Vital Role Of Toxicity Studies In Evaluating New Drugs

The Vital Role Of Toxicity Studies In Evaluating New Drugs

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...

Navigating 505(b)(1), 505(b)(2) and 505(j) Drug Approval Pathways

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...