New Drug Development and Approval Research Paper

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Initial product formulation utilizes knowledge acquired from pre-formulation outcomes to derive proper dose, dosage form, and type of administration for the proposed marketed use. A pilot batch of Clinical Trial Materials (CTM) may be produced after the new drug has completed these initial tests.

Upon completion of preclinical testing, the drug sponsor files an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), after they have obtained prerequisite approval from the Institutional Review Board (IRB). The purpose of the investigation is to assure that the new drug is safe and meets stated objectives for human consumption. Among other things, all formulations must meet FDA Current Good Manufacturing Practice guidelines before human testing can begin. Ordinarily, the FDA has 30 days to respond to the application. After the drug receives this initial approval clinical trials may begin within 30 days.

Clinical trials proceed in four phases, with each phase increasing in number of test subjects and duration. Phase I verifies safety of the new drug entity; 67% of drugs successfully complete Phase I. Phase II evaluates the drug's effectiveness; 45% of drugs have a Phase II positive outcome.

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Phase III verifies efficacy and ascertains possible adverse reactions in large populations; 5-10% of drugs successfully complete this phase. Lastly, Phase IV concentrates on post-marketing surveillance which seeks to identify adverse reactions that are rare and go undetected during previous studies, monitor known reactions, and identify other risk factors.

Following the completion of clinical trials, the sponsoring company evaluates the statistical data and, if the findings support a safe drug with therapeutic effectiveness, files a New Drug Application (NDA) with the FDA to seek permission to market the new drug product in the U.S.A. The NDA gives a comprehensive, lengthy presentation of relevant data, which often consisting of several hundred volumes. Regulation permits the FDA 180 days to complete a review of the NDA, which may be extended if both parties agree. When the NDA receives approval from the FDA, the sponsor may begin marketing, and physicians may prescribe the new medication. The company continues to submit follow-up reports on the new drug, noting any adverse reactions which may suggest quality control measures......

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