Regulatory forum opinion piece: Blind reading of histopathology slides in general toxicology studies

Toxicologic Pathology

Volumn 40, Issue 4, 2012, Pages 697-699

  Neef, Natasha ^a   Nikula, Kristen J ^b   Francke Carroll, Sabine ^c   Boone, Laura ^d  

^a BRISTOL MYERS SQUIBB   (United States)

^b Seventh Wave Laboratories   (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^d Covance Laboratories ^*  (United States)

Author keywords

histopathology; preclinical safety assessment risk management; regulatory affairs; risk assessment; toxicologic pathology

Indexed keywords

HAZARD; HISTOPATHOLOGY; HUMAN; PATHOLOGIST; PATIENT SAFETY; PRIORITY JOURNAL; READING; REVIEW; RISK ASSESSMENT; SENSITIVITY ANALYSIS; STUDY DESIGN; TOXICOLOGY;

BIAS (EPIDEMIOLOGY); HISTOLOGY; HUMANS; PATHOLOGY; RESEARCH DESIGN; RISK ASSESSMENT; TOXICOLOGY;

EID: 84861820455     PISSN: 01926233     EISSN: 15331601     Source Type: Journal    
DOI: 10.1177/0192623312438737     Document Type: Review

References (3)

1. EFSA Scientific Committee, 2011. Draft for public consultation - Scientific Opinion EFSA guidance on repeated-dose 90-day oral toxicity study on whole food/feed in rodents [45pp.]Available onlinewww.efsa.europa.eu
2. Holland T., Holland C. Analysis of unbiased histopathology data from rodent toxicology studies (or, are these groups different enough to ascribe it to treatment?. Toxicol Pathol. 2011 ; 39: 569-75
3. Kaptchuk T. J. Effect of interpretive bias on research evidence. BMJ. 2003 ; 326: 1453-55