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A Practical Tool for Risk-Based In-use Compatibility Assessments.

Bruce D Mason1, Kris Lowe1, Jinquan Dong1

  • 1Drug Product and Device Development, Takeda Pharmaceuticals U.S.A., Inc. 200 Shire Way, Lexington, MA 02421, USA.

Journal of Pharmaceutical Sciences
|August 9, 2023
PubMed
Summary
This summary is machine-generated.

Drug development requires in-use compatibility studies. A new risk assessment tool helps determine if testing is needed for component changes during clinical trials, potentially saving significant time and resources.

Keywords:
DeliveryDevelopmentEnzymesIn-use stability and compatibilityIntravenousMonoclonal antibodiesRisk assessmentScience-basedToolmAbs

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Clinical Trials

Background:

  • In-use compatibility studies are vital for drug product quality during administration.
  • Changes in drug delivery components during clinical trials can cause delays and require extensive assessment.
  • Standardized science-based risk evaluation methods for these changes are lacking.

Purpose of the Study:

  • To develop a risk assessment tool for evaluating the necessity of in-use testing when drug delivery components change during clinical trials.
  • To provide a standardized, science-based approach for decision-making in such scenarios.
  • To expedite drug development timelines and reduce unnecessary testing.

Main Methods:

  • Development of an Excel™-based semi-quantitative risk assessment tool.
  • Tool based on multi-company experience with compatibility studies across diverse drug products and regions.
  • Application of the tool to expedite decision-making and reduce testing in low-risk situations.

Main Results:

  • The risk assessment tool aids in determining the need for in-use testing following changes in drug delivery components.
  • Implementation of the tool can expedite decision-making and reduce testing requirements.
  • Estimated time savings of at least 6-9 months in the development cycle are achievable.

Conclusions:

  • The developed risk assessment tool offers a practical solution for managing component changes during clinical trials.
  • It enables efficient, science-based evaluations, saving time and resources.
  • The tool is adaptable for various drug products, dosing regimens, and can benefit companies with limited resources.