title: Is It Adverse, Nonadverse, Adaptive, or Artifact?
abstract: 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.
authors: 1 National Toxicology Program, Research Triangle Park, North Carolina, USA.
authors: Arun R
authors: AR
authors: Pandiri
authors: 2 Drug Safety Research and Development, Pfizer Inc., Groton, Connecticut, USA.
authors: Roy L
authors: RL
authors: Kerlin
authors: 3 Experimental Pathology Laboratories, Inc., Northwest, Seattle, Washington, USA.
authors: Peter C
authors: PC
authors: Mann
authors: 4 Amgen Inc., South San Francisco, California, USA.
authors: Nancy E
authors: NE
authors: Everds
authors: 5 Covance Laboratories, Madison, Wisconsin, USA.
authors: Alok K
authors: AK
authors: Sharma
authors: 6 U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors: L Peyton
authors: LP
authors: Myers
authors: 7 Experimental Pathology Laboratories, Inc., Durham, North Carolina, USA.
authors: Thomas J
authors: TJ
authors: Steinbach
mesh_terms: D000222:Adaptation, Physiological; D000818:Animals; D016477:Artifacts; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology*; D017408:Guidelines as Topic; D019055:No-Observed-Adverse-Effect Level; D010336:Pathology / Q000379:methods* / Q000592:standards; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards
keywords: adaptive response; adversity; artifact; nonadverse response