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Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the

Paul A Dickinson1, Filippos Kesisoglou2, Talia Flanagan3

  • 1Seda Pharmaceutical Development Services, The Biohub at Alderley Park, Alderley Edge, Cheshire, UK SK10 4TG.

Journal of Pharmaceutical Sciences
|September 24, 2016
PubMed
Summary
This summary is machine-generated.

The Biopharmaceutics Risk Assessment Roadmap (BioRAM) and its Scoring Grid optimize drug product clinical performance. This integrated strategy enhances decision-making and accelerates drug development timelines.

Keywords:
Biopharmaceutics Classification System (BCS)Biopharmaceutics Risk Assessment Roadmap (BioRAM)bioavailabilityclinical trial simulationsdrug deliveryin silico modelingin vitro and in vivo correlations/relationships (IVIVC/R)in vitro modelspharmokinetic/pharmacodynamic modelsquality by design (QbD)

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Clinical Pharmacology

Background:

  • Optimizing clinical performance of drug products is crucial for therapeutic success.
  • Current drug development processes can be lengthy and complex, impacting timely decision-making.
  • An integrated systems approach is needed to address critical questions in drug formulation and delivery.

Purpose of the Study:

  • To introduce and illustrate the application of the Biopharmaceutics Risk Assessment Roadmap (BioRAM) and its companion Scoring Grid.
  • To facilitate the optimization of clinical performance for drug products through a therapy-driven approach.
  • To highlight the importance of timely decision-making and action in drug development.

Main Methods:

  • The BioRAM strategy employs an integrated systems approach focusing on therapy-driven drug delivery.
  • The BioRAM Scoring Grid guides the implementation of this strategy across 12 critical areas and 6 assessment stages.
  • Application of the Scoring Grid is demonstrated using examples from published literature.

Main Results:

  • The BioRAM strategy defines risk as failure to achieve intended in vivo drug product performance.
  • Success is measured by the speed of decision-making and subsequent actions.
  • The Scoring Grid provides a structured framework for applying the BioRAM strategy.

Conclusions:

  • BioRAM offers a creative and innovative systems approach to drug development.
  • Implementation of BioRAM is expected to significantly impact drug development and foster collaborations.
  • The strategy emphasizes the value of well-defined questions and integrated study designs for efficient drug development.