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September 5, 2025

Strategic Impurity Control in Next-Generation Pharmaceuticals: Analytical Technologies, Toxicological Assessment, and Regulatory Integration

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Overview

Systematic review integrates analytical technologies and toxicological assessment to optimize impurity control for pharmaceutical safety.

Key Points

  • The systematic review finds that integrating advanced analytical technologies improves impurity profiling and detection.
  • Implementation of models such as the threshold of toxicological concern enhances safety evaluation for pharmaceuticals.
  • The review emphasizes the importance of regulatory integration, aligning Quality by Design with international guidelines.
  • Opportunities for harmonization include promoting predictive toxicology databases and streamlining global practices.

Cite This Study

A 2025 study studied this question.

synapsesocial.com/papers/68c238d2b210217d647796ffhttps://doi.org/10.25163/biomedical.9110292
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