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Updated: May 30, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach

Patricia Parris1, Geraldine Whelan2, Martyn L Chilton3

  • 1Pfizer Worldwide Research, Development and Medical, Sandwich, UK.

Regulatory Toxicology and Pharmacology : RTP
|January 30, 2025
PubMed

Keywords:
In silicoLeachablesPotencyRisk assessmentSafety concern thresholdSensitizationextractables

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