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Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars.

Ryuji UozumiChikuma Hamada
Published in: Therapeutic innovation & regulatory science (2017)
This proposal provides appealing advantages, such as a shorter time period, additional cost savings, and a smaller number of patients required.
Keyphrases
  • end stage renal disease
  • newly diagnosed
  • ejection fraction
  • chronic kidney disease
  • peritoneal dialysis
  • prognostic factors