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Research and Development of New Generic Drugs NAPAPAT RATTANACHITTHAWAT, MS. IN PHAM TECH OCTOBER 18TH, 2018 RESEARCH AND DEVELOPMENT OF PHARMACEUTICAL PRODUCTS (794628) BURAPHA UNIVERSITY 2 Contents  What are generic drugs ?  New Drugs & Generic Drugs review process  Terminology Bioequivalence study  3 What are generic drugs? Original drugs  Original or brand-name drug is originally developed by the pharmaceutical company.  The company must first gain approval from the Food and Drug Administration (FDA). New Chemical Entities (NCE) New Indication (NI) New Combination (NCO) New Delivery System (ND) New Route of Administration (NR) New Dosage Form (NDOS) New Strength (NS) 4 5 What are generic drugs? Generic drugs  The drug contains the same active ingredient(s) as the original drug, in the same dosage form, at the same dose or concentration, and for the same route of administration  Works in the same way and provides the same clinical benefit as its brand-name version.  A generic drug can be produce after the original drug’s patent has expired. Original & Generic Drugs 6  Once all the equivalency tests have been conducted, the generic drug is considered a therapeutic equivalent.  This means that the drug will do the same thing via the same mechanism, and will also follow the same distribution, metabolism and elimination pathways in the body. 7 Original VS Generic Drugs Similarities Original Active ...
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