Importance of Peer Review in Toxicological Pathology and Its Practical Approach

독성병리 Peer Review의 중요성과 실제적 접근방법

  • 손우찬 ;
  • 김배환 ((주)태평양 기술연구원 전임상연구센타) ;
  • 장동덕 (국립독성연구원 독성연구부) ;
  • 한범석 (국립독성연구원 독성연구부) ;
  • 양기화 (국립독성연구원 독성연구부) ;
  • 이영순 (서울대학교 수의과대학 수의공증보건학교실)
  • Published : 2004.03.01

Abstract

Evaluation of toxicological pathology is to some extend subjective judgments by pathologist and the accuracy of pathologist's works is based on the individual training and experiences. It has been required to establish a peer review system for toxicologic pathology and these review system has been employed by various practice of toxicological pathology. It would be pointed out that the possible causes of drifts in pathology are due to 1) lack of knowledge or experience of individual pathologists, 2) poorly maintained consistence of grading among animals in study, 3) different interpretation of findings between pathologists, or 4) pathology data processing. Example cases of diagnostic errors and current practice of peer review including tissue selection criteria, documentation and problem resolution for short-term and carcinogenicity studies were introduced. For sound regulatory system and high integrity of practice in toxicological pathology, current approaches of peer review system were reviewed.

Keywords

References

  1. Arp, L.H. (1999): Tumor models: Assessing toxicity in efficacy studies, Toxicol. Pathol., 27,121-122 https://doi.org/10.1177/019262339902700123
  2. Berg, T, Cassel, TN., Schwarze, P.E. and Nord, M. (2002): Glucocorticosteroids regulate the CCSP and CYP2B1 promoters via C/EBP${|beta}$ and ${|delta}$ in lung cells. Biochem. Bio-phys. Res. Commun., 293, 907-912
  3. Bucci, T.J. (1991): Evaluation of altered morphology in Handbook of Toxicologic Pathology (W.M. Haschek and C.G. Rousseaux, Eds.). Academic Press, San Diego, California, pp. 23-48
  4. Bucci, T.J. (2002): Basic techniques in Handbook of Toxicologic Pathology (WM. Haschek and C.G. Rousseaux, Eds.). Academic Press, San Diego, California, pp. 171-185
  5. Capen, C.C. (1993): The Endocrine Glands in Pathology of Domestic Animals, (4 th edition). (K.V.F. Jubb, P.C. Kennedy and N. Palmer, Eds.). vol. 3, Academic Press, San Diego, California, pp. 326-329
  6. Cheeke, PR. and Amberg, J.W. (1973): Comparative calcium excretion by rats and rabbits. J. Anim. Sci., 37, 450-454
  7. Enomoto, M. and Akazaki, K. (1987): Color atlas of toxicological pathology. Soft Science Publications, Tokyo, pp. 216-217
  8. Fletcher, TF. (1979): Spinal cord and meninges in Miller's Anatomy of the Dog (HE Evans and G.C. Christensen Eds.). London, WB Saunders Company, pp. 935-964
  9. Hardisty, J.F., Boorman, G.A., Harada, T. and Popp, J.A. (1990): Thyroid gland in Pathology of the Fischer Rat (G.A. Boorman, S.L. Eustis, M.R. Elwell, CA Montgomery and W.F. MacKenzie Eds.). Academic Press, San Diego, California, pp. 519-536
  10. Hooks, W.N., Harling, R.J., Harling, S.M. and Gopinath, C. (1999): A comparison of the in-life parameters and preliminary tumour data in ten gang-housed dietary tumorigenic-ity studies using the Charles River International Genetic standard or original strain designations of Sprague-Daw-ley rat in Biological Reference Data on CD(SD)IGS Rats (T. Matsuzawa, Ed.). Yamanouchi Pharmaceutical Co. Ltd., Japan, pp. 229-235
  11. Li, X., Elwell, R.E., Ryan, A.M. and Ochoa, R. (2003): Morphogenesis of postmortem hepatocyte vacuolation and liver weight increases in Sprague-Dawley rats. Toxicol. Pathol., 31, 682-688
  12. Liebelt, A.G. (1986): Unique feature of anatomy, histology, and ultrastructure, kidney, mouse in Urinary System, Monographs on Pathology of Laboratory Animals (T.C. Jones and U. Mohr, Eds.). vol. 4, Springer-Verlag, Berlin, pp.24-44
  13. Mann, PC., Hardisty, J.F. and Parker, M.D. (2002): Manag-ing pitfalls in toxicologic pathology in Hand Book of Toxi-cologic Pathology (W.M. Hascheck, C.G. Roussexaux, and M.A. Wallig, Eds.). San Diego, Academic Press, pp. 187-206
  14. Mcconnell, E.E. and Eustis, S. (1994) Peer review in carcino-genicity bioassays: uses/abuses. Toxicol. Pathol., 22, 141-144
  15. Percy, D.H. and Barthold, S.W (1993) Pathology of labora-tory rodents and rabbits. Iowa, Iowa University Press, pp. 179-181
  16. Son, W.C., Kim, J.C. and Yu, I.J. (2003a): 정자생성 주기법을 이용한 고환독성 평가 필요성과 정량적인 고환독성 평가방법에 대한 고찰. J. Toxieol. Pub. Health, 19, 83-90
  17. Son, W.C. (2003): Factors contributory to early death of young CD-1 mice in carcinogenicity studies. Toxicol. Lett., 145, 88-98
  18. Son, W.C., Kamino, K., Lee, Y.S. and Kang, K.S. (2003b): Strain-specific mammary proliferative lesions development following life-time oral administration of Ochratoxin A in DA and Lewis rats. Int. J. Cancer, 105, 305-311
  19. The European Agency for the Evaluation of Medicinal Prod-ucts Evaluation of Medicines for Human Use, London, (2002): CPMP/SWP/2877/00, Committee for proprietary medicinal products (CPMP), Note for guidance on carcinogenic potential. (issued 25 July 2002)
  20. The OECD guideline (1999): ENV/JM/MONO(99)4, Series on pesticides No. 14, Environment directorate joint meeting of the committee and the working party on chemicals. Environmental health and safety publications. Guidance notes for analysis and evaluations of chronic toxicity and carcinogenicity studies. (issued 17 Feb., 1999)
  21. The OECD guideline (2002): ENV/JM/MONO(2002)19, Envi-ronment directorate joint meeting of the committee and the working party on chemicals, pesticides and biotechnology. (issued 4 Sep., 2002)
  22. U. S. Environmental Protection Agency (1987): Pesticide Regulation (PR) Notice 87-10, Pathology raw data definitions as it relates to pathology trails and independent pathology peer review system. (issued Oct., 9, 1987)
  23. U. S. Environmental Protection Agency (1994): Pesticide Regulation (PR) 94-5, Notice to Registration of Pesticide Products. (issued Aug., 24, 1994)
  24. Ward, J.M., Hardisty, J.F., Hailey, J.R. and Streett, C.S. (1995): Peer review in toxicologic pathology. Toxicol. Pathol., 23, 226-234
  25. Wasano, K. and Hirakawa, Y. (1992): Morphological heteroge-neity of secretory granules of rat Clara cells: an immuno-cytochemical study. Histochemistry, 98, 165-171 https://doi.org/10.1007/BF00315875