Choice of morphometric methods and consequences in the regulatory environment.
Toxicol Pathol
; 38(7): 1128-33, 2010 Dec.
Article
in En
| MEDLINE
| ID: mdl-20884817
ABSTRACT
In certain cases, quantitative tissue structural data derived from tissue sections may be required to make critical decisions in the drug development or risk assessment process. Most frequently, these questions center on test article-related effects on cell number. In this opinion article, the limitations of estimating cell number by standard cell or nuclear profile counts from sections/blocks collected for routine histopathology are discussed from both a scientific and regulatory perspective and contrasted with the robust, sensitive, statistically based methods of design-based stereology. Specific existing industry practices are reviewed. Recent advances in stereological theory, software, hardware, and automated immunohistochemical staining now make it feasible to implement unbiased stereological methods to assess test article-related effects on cell number in a regulatory toxicology setting. These design-based stereological methods for counting cells are recommended when the quantification of small changes in cell number is critical to the risk assessment or decision-making process. These methods provide levels of sensitivity and statistical guarantees of accuracy that no other currently available tissue section-based methodology can provide.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pathology
/
Research Design
/
Toxicity Tests
/
Imaging, Three-Dimensional
/
Government Agencies
/
Microscopy
Type of study:
Diagnostic_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Animals
Language:
En
Journal:
Toxicol Pathol
Year:
2010
Document type:
Article
Affiliation country:
Estados Unidos