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Biologies clinical development plan

The most relevant risk to be considered during the development of a biological pharmaceutical is the efficacy and safety in the target organism. Despite extensive preclinical tests, many product candidates are abandoned after first tests in humans. The problems encountered at this stage are often due to pharmacological or immunological differences between the model used in the preclinical tests and humans. Thus, it is necessary to plan Phase I clinical trials as early as possible. [Pg.40]

Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin SL, Kuebler J. et al. 2009. Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development A report of the safety planning, evaluation, and reporting team. Clinical Trials 6(5) 430-440. [Pg.10]

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