Adaptive seamless design for establishing pharmacokinetics and efficacy equivalence in developing biosimilars

15 May 2017 Uozumi Ryuji Hamada Chikuma

Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate the equivalence of pharmacokinetics (PK) and clinical efficacy. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available... (read more)

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