A commentary on the process of peer review and pathology data locking

Author:

McKay Jennifer S.,Barale-Thomas Erio,Bolon Brad,George Catherine,Hardisty Jerry,Manabe Sunao,Schorsch Frédéric,Teranishi Munehiro,Weber Klaus

Publisher

Elsevier BV

Subject

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

Reference17 articles.

1. Barale-Thomas E, Bradley A. Results of the “Peer review survey”: the report is open for comments. In: Poster presented at the annual general meeting of the European Society of Toxicologic Pathology, held September 15–18, 2009, The Hague, The Netherlands, 2009.

2. Code of Federal Regulations (CFR), vol. 21, part 58 〈http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58〉 (accessed 6 August 2010) and part 11 〈http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11〉 (accessed 6 August 2010).

3. Committee for Proprietary Medicinal Products, 2009. Note for guidance on carcinogenic potential. CPMP/SWP/2877/00 25 July 2002. Available from: 〈http://www.emea.europa.eu/pdfs/human/swp/287700en.pdf〉 (accessed 21 December 2009).

4. Committee on the Carcinogenicity of Chemicals in Food, 2009. Consumer products and the environment. The Organisation for Economic Cooperation and Development (OECD) guidance document for the performance of chronic toxicity and carcinogenicity studies. Investigations (including Histopathological Guidance). Annex 1 to CC/09/09 [chapter 3.6]. Available from: 〈http://iacoc.org.uk/papers/documents/CC0909OECDGuidanceUKChapter.pdf〉 (accessed 21 December 2009).

5. Best practices guideline: toxicologic histopathology;Crissman;Toxicol Pathol,2004

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1. Best Practice in Toxicological Pathology;A Comprehensive Guide to Toxicology in Nonclinical Drug Development;2017

2. Best Practice in Toxicological Pathology;A Comprehensive Guide to Toxicology in Preclinical Drug Development;2013

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