Dermatological Drug Development

Released on by Tomoko Maeda-Chubachi
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  • Dermatological Drug Development Book Detail

  • Author : Tomoko Maeda-Chubachi
  • Release Date : 2020-09-18
  • Publisher : Cambridge Scholars Publishing
  • Genre : Medical
  • Pages : 146
  • ISBN 13 : 152755967X
  • File Size : 74,74 MB
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Dermatological Drug Development by Tomoko Maeda-Chubachi PDF Summary

Book Description: This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).

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