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Accelerated Development of Pharmaceuticals Past, Present, and Future.

Stephen R Byrn1

  • 1Department of Industrial and Molecular Pharmaceutics, Purdue University, West Lafayette, IN, USA. sbyrn@purdue.edu.

Pharmaceutical Research
|August 6, 2024
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Summary

This review explores pharmaceutical development acceleration, from 1990s strategies to current PK/PD advancements and future outlooks. It covers case studies and rapid manufacturing for vaccines and nanoparticles.

Keywords:
accelerated developmentlipidnanoparticlespreformulationsolid-state chemistry

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Biotechnology

Background:

  • Early pharmaceutical development relied on traditional timelines.
  • The need for faster drug delivery has driven innovation.
  • Historical initiatives in the 1990s laid groundwork for expedited processes.

Purpose of the Study:

  • To review the evolution of accelerated pharmaceutical development.
  • To analyze key strategies and case studies in drug development acceleration.
  • To provide perspectives on current and future trends in rapid pharmaceutical manufacturing.

Main Methods:

  • Historical analysis of drug development initiatives.
  • Review of pharmacokinetic/pharmacodynamic (PK/PD) applications.
  • Examination of case studies like INDIGO and Chorus programs.
  • Analysis of conference proceedings (NIPTE) for industrial insights.

Main Results:

  • Pharmaceutical development acceleration has evolved significantly since the 1990s.
  • Pharmacokinetic/pharmacodynamic (PK/PD) modeling emerged as a key accelerator in the 2000s.
  • Successful case studies demonstrate the feasibility of accelerated drug development pathways.

Conclusions:

  • Accelerated pharmaceutical development requires strategic planning and adaptive methodologies.
  • Current trends focus on industrial perspectives and rapid manufacturing of novel therapeutics, including vaccines and Solid Lipid Nanoparticles.
  • Future pharmaceutical development will likely incorporate further technological advancements for speed and efficiency.