title: Revisit the 21-day cumulative irritation test - statistical considerations.
abstract: The 21-day cumulative irritation test is widely used for evaluating the irritation potential of topical skin-care products. This test consists of clinician's assessment of skin reaction of the patch sites and a classification system to categorize the test product's irritation potential. A new classification system is proposed which enables us to control the estimation error and provides a statistical confidence with regard to the repeatability of the classification.
authors.affiliation: a Johnson and Johnson Consumer Inc. , Morris Plains , NJ , USA and.
authors.forename: Paul
authors.initials: P
authors.lastname: Zhang
authors.affiliation: b Xian Janssen Pharmaceutical Ltd , Johnson and Johnson , China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Li
mesh_terms: D003627:Data Interpretation, Statistical; D006801:Humans; D007509:Irritants / Q000145:classification / Q000633:toxicity*; D018401:Sample Size; D023422:Skin Irritancy Tests / Q000706:statistics & numerical data*
chemical_list: D007509:Irritants
keywords: Evaluation method; irritation; skin-care products