Hostname: page-component-586b7cd67f-t8hqh Total loading time: 0 Render date: 2024-11-28T17:19:31.463Z Has data issue: false hasContentIssue false

The Role of Microscopy in Preclinical Safety Assessment

Published online by Cambridge University Press:  02 July 2020

Barbara J. Dovey-Hartman*
Affiliation:
Department of Pathology, Schering-Plough Research Institute, 144 Route 94, Lafayette, NJ07848
Get access

Extract

Microscopy plays a vital role in assessing the safety of New Chemical Entities (NCE) in the pre-clinical phase of drug development. Light microscopy (LM), transmission electron microscopy (TEM) and scanning electron microscopy (SEM) are used at the Schering-Plough Research Institute (SPRI) for evaluation of NCE. To support regulatory submissions, NCE are routinely tested in rodents in short-term studies such as one-month toxicity studies, and in longterm studies such as oncogenicity studies that may last 24 months. At the completion of a study, the animals are necropsied and the required tissues collected and stored in fixative. The tissues for LM are processed to slides and stained with Hematoxylin and Eosin (H&E). The information derived from the examination of these tissues by LM becomes an essential part of the pathology report. The LM examination of these tissues usually yields the information needed to either progress a NCE or otherwise deter or halt development.

Type
Microscopy and Microanalysis in the Pharmaceutical Industry
Copyright
Copyright © Microscopy Society of America

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)