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Where New Matter Actually Comes From: CIP Trigger Points in FDA Drug Development Why Preclinical Polymorphs and Phase I Formulation Data Drive Most Secondary Patent Filings The FDAs five-stage development pathway discovery, preclinical, Phase I, Phase II, Phase III and post-approval does not generate patentable new matter at uniform rates

doi: 10.2165/00003495-199957030-00007 174 LipskyBADorrMBMagnerDJTalbotGH

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In conclusion, our data suggest that GSSG is a potent and clinically relevant sensitizer for TNF-induced hepatotoxicity in NAFLD, which represents a potential therapeutic target for NAFLD