A Commentary on the Process of Peer Review and Pathology Data Locking

Author:

McKay Jennifer S.1,Barale-Thomas Erio2,Bolon Brad3,George Catherine4,Hardisty Jerry5,Manabe Sunao6,Schorsch Frédéric7,Teranishi Munehiro6,Weber Klaus8

Affiliation:

1. AstraZeneca, Macclesfield, SK10 4TG, United Kingdom

2. Johnson and Johnson PRD, 2340 Beerse, Belgium

3. GEMpath Inc., Longmont, CO 80503-2339, USA

4. Ipsen, 91966 Les Ulis Cedex, France

5. Experimental Pathology Laboratories, Research Triangle Park NC 22709, USA

6. Daiichi Sankyo Co., Ltd., Japan

7. Bayer CropScience, 69009 Lyon, France

8. Harlan Laboratories, 4452 Itingen, Switzerland

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

Reference17 articles.

1. Code of Federal Regulations (CFR), Volume 21, Part 58 and Part 11.

2. Committee for Proprietary Medicinal Products. (2002). Note for guidance on carcinogenic potential. CPMP/SWP/2877/00, http://www.emea.europa.eu/pdfs/human/swp/287700en.pdf.

3. Committee on the Carcinogenicity of Chemicals in Food, Consumer Products, the Environment. Chapter 3.6: Investigations (including histopathological guidance). In The Organisation for Economic Co-operation and Development (OECD) Guidance Document for the Performance of Chronic Toxicity and Carcinogenicity Studies. Annex 1 to CC/09/09, http://iacoc.org.uk/papers/documents/CC0909OECDGuidanceUKChapter.pdf.

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1. GIQAR position paper on pathology peer review;Accreditation and Quality Assurance;2014-06-24

2. Histopathology in Toxicity Studies for Study Directors;The Role of the Study Director in Nonclinical Studies;2014-05-09

3. Regulatory Forum Opinion Piece*;Toxicologic Pathology;2013-08-19

4. Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries;Veterinary Clinical Pathology;2013-07-25

5. Peer Review and Pathology Working Groups;Haschek and Rousseaux's Handbook of Toxicologic Pathology;2013

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