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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...