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Initiating Clinical Programs (IND and IMPD)

  • Pieter H. Joubert
  • Silvia M. Rogers

Abstract

A main milestone in drug development is the initiation of studies in humans. Studies with a new medicinal product require approval by regulatory authorities and ECs (Institutional Review Board: IRB). To take this step, the key information required includes the following:

Keywords

Medicinal Product Human Data Drug Development Program Target Profile Convenient Dosage 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Pieter H. Joubert
    • 1
  • Silvia M. Rogers
    • 2
  1. 1.PHJ Consult Ltd.PangbourneUK
  2. 2.Mediwrite GmbHBaselSwitzerland

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