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• W1520422555 abstract "Before an immunosuppressant drug can be specifically indicated for use in transplantation, a time intensive process involving discovery, formulation, characterization and preclinical and clinical evaluation is required that ideally culminates in approval by regulatory authorities and acceptance by practitioners and patients. This chapter discusses the step-by-step process followed by pharmaceutical companies, as well as the criteria required of a drug candidate, before gaining regulatory approval. The approval process highlights the close interactions with regulatory agencies required, as well as the rigorous standards required." @default.
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• W1520422555 date "2014-07-25" @default.
• W1520422555 modified "2023-09-25" @default.
• W1520422555 title "Drug Development in Solid Organ Transplantation and the Approval Process for Transplant Immunosuppressants" @default.
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• W1520422555 doi "https://doi.org/10.1002/9781118873434.ch141" @default.
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