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Related Experiment Video

Updated: Jan 22, 2026

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Peripheral Nerve Microscopic Changes Related to Study Procedures: Two Nonclinical Case Studies.

Dinesh S Bangari1, Ingrid D Pardo2, Rani Sellers3

  • 1Global Discovery Pathology, Sanofi, Framingham, MA, USA.

Toxicologic Pathology
|July 20, 2019
PubMed
Summary
This summary is machine-generated.

Procedure-related nerve damage in nonclinical studies can mimic test article effects. Careful review of study procedures is essential to accurately assess peripheral nerve safety during therapeutic development.

Keywords:
brachial plexusiatrogenic neuropathynerve degenerationneuropathyperipheral nervesretro-orbital sinus puncturestudy proceduretrigeminal neuropathy

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Area of Science:

  • Neuroscience
  • Toxicology
  • Preclinical Research

Background:

  • Peripheral nerve examination is crucial in nonclinical safety assessments of therapeutics.
  • Histologic changes in nerves can arise from both test articles and study procedures like injections and sampling.

Purpose of the Study:

  • To present case studies of procedure-related histologic changes in peripheral nerves.
  • To highlight the importance of distinguishing these changes from test article-induced effects.

Main Methods:

  • Two nonclinical case studies involving mice and rats were analyzed.
  • Histologic examination of trigeminal and brachial plexus nerves was performed.

Main Results:

  • Mouse trigeminal nerves showed axonal degeneration and macrophage infiltration after retro-orbital sinus puncture.
  • Rat brachial plexus exhibited inflammation, hemorrhage, and nerve fiber degeneration due to handling and blood sampling.

Conclusions:

  • Procedure-related nerve changes can be morphologically identical to test article effects.
  • Thorough evaluation of study procedures and incidence/severity across groups is vital for accurate safety assessments.