Pathology raw data in nonclinical laboratory studies for the pharmaceutical industry: The pathologists' view

Quality Assurance Journal

Volumn 8, Issue 3, 2004, Pages 161-166

  Geoly, Frank J ^a   Kerlin, Roy L ^a  

^a PFIZER INC   (United States)

Author keywords

Diagnoses; FDA; GLP; Histopathology; Nonclinical; Peer review; Phathology; Quality assurance; Raw data

Indexed keywords

AUTOPSY; DRUG INDUSTRY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; HAZARD; HISTOPATHOLOGY; HUMAN; INFORMATION PROCESSING; PATHOLOGIST; PATHOLOGY; PRIORITY JOURNAL; QUALITY CONTROL; REGULATORY MECHANISM; REVIEW;

EID: 4344622306     PISSN: 10878378     EISSN: None     Source Type: Journal    
DOI: 10.1002/qaj.278     Document Type: Review

References (6)

1. United States Code of Federal Regulations. Title 21. Part 58, Section 58.3(k). Revised July 1991. http:www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/CFRSearch.cfm.
2. United States Code of Federal Regulations. Title 21, Part 58, Section 58.130(e). Revised July 1991. http://www.accessdata. fda.gov/scripts/cdrh/ cfdocs/cfcfr/CFRSeareh.cfm.
3. United States Federal Register. Preamble to the Good Laboratory Practice Regulations 1987; 52(172) September 4, 33768-33782.
4. Society of Toxicologic Pathologists. Peer review in toxicologic pathology: some recommendations. Toxicol Pathol 1991; 19(3): 290-292.
5. Society of Toxicologic Pathologists. Documentation of pathology peer review. Toxicol Pathol 1997; 25(6):655.
6. Lepore PD. Pathology raw data. Toxicol Pathol 1996; 24(1):147.