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希少疾患治療薬開発の課題と機会

希少疾患治療薬開発の課題と機会

Developing new drugs for rare diseases is challenging. The small patient populations for these indications add complexity to designing and conducting clinical trials, the data interpretation that follows, and the ultimate path to registration.

This whitepaper by drug development experts, Drs. Julie Bullock and Rajesh Krishna, reflects on some of the challenges and opportunities in rare disease drug development.

Read it to learn:

  • An overview of the biology and genetics of rare diseases
  • How to leverage regulatory frameworks to reduce regulatory uncertainty
  • The challenges of the accelerated approval mechanism
  • How to streamline rare disease drug development using model-informed drug development

 

Simply fill out the form and download the white paper!

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