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Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.

, S F Marshall1, R Burghaus2

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|April 13, 2016
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Summary
This summary is machine-generated.

This white paper provides recommendations for Model-Informed Drug Discovery and Development (MID3) to improve consistency and quality. It aims to benefit decision-makers, analysts, and regulators in the pharmaceutical industry.

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Area of Science:

  • Pharmaceutical Sciences
  • Computational Chemistry
  • Drug Development

Background:

  • Inconsistent practices in Model-Informed Drug Discovery and Development (MID3) hinder efficiency and quality.
  • Heterogeneity in MID3 implementation and documentation requires standardization.

Purpose of the Study:

  • To establish "good practice" recommendations for MID3 across the pharmaceutical industry.
  • To enhance consistency in the practice, application, and documentation of MID3.
  • To provide a foundation for developing MID3-related regulatory guidelines.

Main Methods:

  • Assembly of "good practice" recommendations.
  • Focus on minimizing heterogeneity in MID3 quality and content.
  • Targeted information for decision-makers, analysts, and regulatory authorities.

Main Results:

  • A framework for consistent MID3 implementation and documentation.
  • Guidance to improve R&D efficiency through strategic MID3 integration.
  • Material to enhance the planning, rigor, and consistency of MID3 application.

Conclusions:

  • Standardized MID3 practices will improve pharmaceutical R&D efficiency.
  • This document supports analysts in rigorous and consistent MID3 application.
  • Provides a basis for regulatory bodies to develop MID3 guidelines.