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Innovative early development regulatory approaches: expIND, expCTA, microdosing.

W T Robinson1

  • 1Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. William.robinson@novartis.com

Clinical Pharmacology and Therapeutics
|December 20, 2007
PubMed
Summary
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Regulatory guidances for exploratory investigational new drugs (INDs) and clinical trial applications (CTAs) aim to streamline drug development. This review examines the history and industry use of these important efficiency initiatives.

Area of Science:

  • Drug Development and Regulatory Science
  • Pharmaceutical Policy and Innovation

Background:

  • The Food and Drug Administration (FDA) Critical Path Initiative and the European Medicines Agency (EMA) Road Map highlight the need for efficient drug development processes.
  • Emerging regulatory guidances for exploratory Investigational New Drugs (INDs) and Clinical Trial Applications (CTAs) represent a key response to these calls for efficiency.

Purpose of the Study:

  • To review the historical development of guidances for exploratory INDs/CTAs.
  • To analyze the industry's experience and utilization of these guidances to date.

Main Methods:

  • Historical review of regulatory guidance evolution.
  • Analysis of industry adoption and practical application of exploratory IND/CTA guidances.

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Main Results:

  • Exploratory IND/CTA guidances have emerged as a significant initiative to improve drug development efficiency.
  • The article synthesizes the history and current industry experience with these guidances.

Conclusions:

  • These guidances are crucial for optimizing the early stages of drug development.
  • Continued industry engagement with and refinement of these regulatory pathways are essential for future pharmaceutical innovation.