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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...

Good Communication Essential To Successful Preclinical Testing

Good Communication Essential To Successful Preclinical Testing

For both large and small drug development companies, good communication displayed throughout the preclinical testing process is essential to success. Project leaders who exhibit great awareness, flexibility and communication skills can’t be undervalued in the timely...

Pathologists Can Move Your Drug Development Program Forward

Pathologists Can Move Your Drug Development Program Forward

Pathologists examine the causes and mechanisms of diseases and, in the world of drug development, that means collecting, processing and analyzing tissue for toxicity. Histotechnologists fix tissue samples onto slides, stain them to distinguish types of cells and cell...