De-risking in Tier I CNS safety assessments is the primary function of study design and technical training of laboratory staff observers.

Gauvin, David V; Zimmermann, Zachary J; Dalton, Jill A

Gauvin, David V; Zimmermann, Zachary J; Dalton, Jill A.

Affiliation

Gauvin DV; Neurobehavioral Sciences, Charles River Laboratories, Mattawan, 49071, MI, USA. Electronic address: david.gauvin@crl.com.
Zimmermann ZJ; Neurobehavioral Sciences, Charles River Laboratories, Mattawan, 49071, MI, USA.
Dalton JA; Neurobehavioral Sciences, Charles River Laboratories, Mattawan, 49071, MI, USA.

Regul Toxicol Pharmacol ; 129: 105116, 2022 Mar.

Article in En | MEDLINE | ID: mdl-35017023

Subject(s)

Central Nervous System Agents/adverse effects; Central Nervous System/drug effects; Drug Evaluation, Preclinical/standards; Neurotoxicity Syndromes/diagnosis; Research Personnel/standards; Animals; Drug Development; Humans; Observer Variation; Reproducibility of Results; Research Personnel/education; United States; United States Food and Drug Administration/standards

Key words

Functional observational battery; Neurotoxicology; Nonclinical screening; Safety assessment; Tier I testing

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Personnel / Central Nervous System / Central Nervous System Agents / Neurotoxicity Syndromes / Drug Evaluation, Preclinical Type of study: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Limits: Animals / Humans Country/Region as subject: America do norte Language: En Journal: Regul Toxicol Pharmacol Year: 2022 Type: Article

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