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Abstract

Keywords

histopathology preclinical research and development preclinical safety-assessment/risk management safety assessment regulatory affairs toxicologic pathology.

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References

Arena pharmaceuticals (2011). August 2011: Arena and Eisai Announce Results of Re-Adjudication of Rat Mammary Tumors from Lorcaserin Carcinogenicity Study Press release available online at http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=597830; accessed December 2013.

Englehardt

Hardisty

Mann

(2013). Regulatory Forum Opinion Piece: Pathology Peer Review - To Lock or Not to Lock - Is that really the question? Toxicologic Pathology 41, 1051–1052.

FDA (Food and Drug Administration). (2010). Lorcaserin FDA advisory committee nonclinical briefing document p. 4. www.fda.gov/.../drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm225635.pdf Accessed December 2013

JSTP (Japanese Society of Toxicologic Pathology (2009). Panel discussion: Regulatory perspective for pathology data. J Toxicol Pathol 22, 209–27.

JSTP (2013). Letter from Executive Committees of the European (ESTP), North American (STP), British (BSTP), French (SFPT), Indian (STP-I), Japanese Societies (JSTP) and the International Federation of Societies of Toxicologic Pathologists (IFSTP) to OECD GLP Operations manager. www.japantoxpath.org/ja/related/peerreview/peerreview20131115.pdf

Lorentz

G. B. A.

Quekel

M. D.

Alphons

G. H.

Kessels

M. D.

Reginald Goei

M. D.

Joseph

M. A.

van Engelshoven

M. D.

(1999). Miss rate of lung cancer on the chest radiograph in clinical practice Chest. Clin Invest 115, 720–24.

Morton

Sellers

Barale-Thomas

Bolon

George

Hardisty

J. F.

Irizarry

McKay

J. S.

Odin

Teranishi

(2010). Recommendations for pathology peer review. Toxicol Pathol 38, 1118–27.

OECD (Organisation for Economic Co-operation and Development) (2013). Draft OECD guidance on the GLP requirements for peer review of histopathology.

Renfrew. (1992). Error in radiology: Classification and lessons in 182 cases presented at a problem case conference. Radiology 183, 145–50.

10.

Robinson

P. J. A.

(1997). Radiology’s Achilles’ heel: Error and validation in the interpretation of the Rontgen image. Br J Radiol 70, 1085–98.