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Clinical trials First Human Dose

Muller PY, Milton M, Lloyd P, Sims J, Brennan FR. The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Current Opinion in Biotechnology. 2009 20(6) 722-9. [Pg.38]

Product quality, purity and consistency are critically important in the pharmaceutical sector, applying to all stages of the supply chain and final dosed product. The human body is an exceptionally complex system and the full effect of a pharmaceutical product, consisting of the API, impurities and formulation components, is impossible to predict from first principles. The industry relies on rigorous clinical trials to assess drug efficacy, toxicity and side effect profiles. [Pg.25]

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