Is It Adverse, Nonadverse, Adaptive, or Artifact?
Toxicol Pathol
; 45(1): 238-247, 2017 01.
Article
in En
| MEDLINE
| ID: mdl-27770107
One of the principal challenges facing a toxicologic pathologist is to determine and differentiate a true adverse effect from a nonadverse or an adaptive response. Recent publications from the Society of Toxicologic Pathology (STP) and the European STP provide guidance for determining and communicating adversity in nonclinical toxicology studies. In order to provide a forum to inform and engage in a discussion on this important topic, a continuing education (CE) course was held during the 2016 STP Annual meeting in San Diego, CA. The lectures at this course provided guidance on determining and communicating adversity using case studies involving both clinical pathology and anatomic pathology. In addition, one talk also focused on data quality, study design, and interpretation of artifacts that could hinder the determination of adversity. The CE course ended with a talk on understanding adversity in preclinical studies and engaging the regulatory agencies in the decision-making process. This manuscript is designed to provide brief summaries of all the talks in this well-received CE course.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pathology
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Adaptation, Physiological
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Artifacts
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Toxicity Tests
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Drug Evaluation, Preclinical
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Drug-Related Side Effects and Adverse Reactions
Type of study:
Guideline
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Prognostic_studies
Limits:
Animals
Language:
En
Journal:
Toxicol Pathol
Year:
2017
Document type:
Article
Affiliation country:
Country of publication: