Preclinical Overview
Getting to the front of the line in a FDA submission starts with a solid preclinical program. Frontage scientists and technicians are on hand from the beginning to help you with all aspects of your drug development project, from study design to preparation of the final report(s).
An experienced team of professionals, using the state-of-the-art equipment and methods, performs our in vitro ADME studies. Studies include metabolic stability, pathway identification and metabolite ID and profiling, in addition to CYP450, protein binding and aqueous solubility tests.
Other studies coordinated by Frontage include the following:
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Exploratory toxicology
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Definitive toxicology
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Histopathology
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Safety pharmacology studies
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In vivo pharmacokinetic studies of formulations developed by our CMC services team
When preclinical studies are complete, our scientific and regulatory consulting group can help advance your drug candidates from preclinical research to clinical development and on to regulatory approval with technical writing, review and evaluation of the preclinical data. Frontage’s team can assist in preparations for FDA scientific committee meetings and can represent the client as a technical advisor on the team.
