Regulatory Expertise

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...

The Complex Process of Developing a Living Protocol

The Complex Process of Developing a Living Protocol

There are times in the laboratory when experienced scientists may question the direction in a protocol. Their experience, having worked on so many studies, may tempt them to consider conducting the testing a little differently than the directions provided to them. If...

Testing Toxicity to Advance to Phase I Clinical Trials

Testing Toxicity to Advance to Phase I Clinical Trials

Preclinical research teams enter each drug testing project with the same hope – that the drug will meet all the safety requirements in order to advance to phase I clinical trials in humans.  In laboratory experiments, scientists will test their ideas for new...

PROTACs and Their Role in Catalyzing Health Solutions

PROTACs and Their Role in Catalyzing Health Solutions

PROTACs, otherwise known as PROteolysis TArgeting Chimera, emerged as a novel therapeutic modality in drug development and currently show promising clinical results for tackling some of the most complex diseases. PROTACs are designed to leverage the body’s internal...

ICH M10: Preview New Bioanalytical Method Validation Guidance

ICH M10: Preview New Bioanalytical Method Validation Guidance

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a multidisciplinary guideline that governs bioanalytical method validation. Drugs need to contain the correct...