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Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design

Kiyohito Kuno1,2, Satoshi Toyoshima2

  • 11 MSD K.K, Tokyo, Japan.

Therapeutic Innovation & Regulatory Science
|September 19, 2018
PubMed
Abstract

Keywords:
control strategydesign spacequality overall summaryquality-by-design (QbD)real-time release (RTR)

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