Regulatory Forum Opinion Piece*: An Experienced Pathologist Should Be Present at Necropsy for Novel Medical Device Studies
| Autor: | Kathleen A. Funk, Kristen J. Nikula |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Pathology
medicine.medical_specialty Medical device Biomedical Research Device Approval 040301 veterinary sciences business.industry 04 agricultural and veterinary sciences Cell Biology Toxicology 030226 pharmacology & pharmacy Opinion piece Pathology and Forensic Medicine 0403 veterinary science 03 medical and health sciences 0302 clinical medicine Medicine Animals Humans Good laboratory practice business Molecular Biology |
| Zdroj: | Toxicologic pathology. 44(1) |
| ISSN: | 1533-1601 |
| Popis: | Necropsies conducted to support medical device development may be conducted in facilities that do not have the infrastructure in place to support Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) studies and for a variety of reasons they may be conducted without a pathologist present at necropsy. However, when a novel medical device or one that is expected to significantly alter tissues is deployed, or when the surgical model confounds interpretation of device effects, it is the opinion of the authors that an experienced pathologist should be present at necropsy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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