The Buzz around Exploratory INDs
This article was originally published in Start Up
The impact of FDA's Final Guidance on the use of Exploratory IND Studies could be profound for firms ranging from start-ups anticipating their first human drug tests to Big Pharmas with thousands of leads to manage and prioritize. Some service organizations may also benefit from the new regs, which may prompt an early clinical assessment of increasing numbers of compounds.
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The academic pioneers of the biomedical applications for accelerator mass spectrometry have founded Vitalea Science to supply AMS-related services, including assessments of microdosing of early clinical candidates, to pharma and biotech companies.
ADMETRx is building new and improved ADME tools. The technology, a mix of wet lab analysis and computer modeling, attempts to move beyond the go/no go decisions typical of ADME.Instead the company offers clients a ranking of a drugs being tested based on the individual properties being tested.
Accium Biosciences provides accelerator mass spectrometry services to pharmaceutical customers for preclinical and early clinical pharmacokinetic and bioavailability analyses of candidate drug compounds. It is currently the only US commercial AMS supplier with an in-house instrument.