PubMed · 13821962
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A FEINTUCH. Case studies from a generic workshop.. https://pubmed.ncbi.nlm.nih.gov/13821962/
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Personalized medicine is premised on the notion that diagnostic techniques can improve safety or effectiveness of pharmaceutical therapies based upon individual genetic or proteomic make-ups. This article explains how diagnostic techniques and pharmaceutical therapies interact during the US Food & Drug Administration's approval of branded and generic drugs in the US, and how the same labeling requirement for generic drugs of the Hatch-Waxman Act can prevent generic drugs from entering the market when proprietary pharmacogenomic techniques are incorporated into the labeling of a branded drug.
Authors pay their attention to the issue of names of pharmaceuticals and drugs and their relationship to their therapeutic use. They specify way of making names of pharmaceuticals and structure of those names (chemical name, trivial name, generic name, unprotected name--INN, name in dispensatory) and way of making names of drugs (protected titles of original drugs, names of generic drugs). One part of the work comprises a chapter applying to subsidiary pharmaceutical agents and their E-code.