Regulatory

Reproductive Toxicology & the EPA’s Tiered Testing System

Reproductive Toxicology & the EPA’s Tiered Testing System

The endocrine system comprises myriad glands, hormones and receptors throughout the body that regulate biological processes from birth to death. Chief among those processes is the differentiation, growth and function of the human reproductive system. Human...

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 E/L for Biopharma? 4 Essential Things to Know

What Is E/L for Biopharma? 4 Essential Things to Know

Extractable and leachable (E/L) studies are becoming more and more important to drug development programs. Here’s why – and an overview of what E/L looks like for biopharma. As drug manufacturing changes and becomes more flexible with plastic systems, the requirements...

Everything You Need to Know About Single-Use Systems

Everything You Need to Know About Single-Use Systems

Pharmaceutical manufacturers have used single-use products since the 1990s, when plastic filters and tubing were integrated with stainless steel bioreactors, revolutionizing biomanufacturing. Prior to this breakthrough, manufacturers were forced to clean and prepare...

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...