Skip to main content
SpringerLink
Log in

The Inner Cro: Pathology – Necropsy and Gross Pathology

  • Chapter
  • First Online:
Contract Research and Development Organizations-Their History, Selection, and Utilization

  • 429 Accesses

Abstract

A well-managed necropsy operation provides a system that assures that all protocol-required tissues and gross lesions are observed, recorded, and properly fixed, for possible future histopathology evaluation. In regulated safety studies, a necropsy is performed to determine the possible cause of death and/or to detect induced or coincidental pathological alterations in tissues. Typically a complete necropsy includes examination of the external aspects of the body, all orifices; the cranial, thoracic, abdominal, and pelvic cavities and their contents; and the musculature, subcutis, and bone. However, gross observations only types of necropsies can also be performed depending upon the type of study, the objective of the study, or the limitations set by the protocol and the sponsor.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 79.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 139.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  • Aiello, S. E., & Moses, M. A. (Eds.). (2016). Clinical pathology and procedures. In The Merck veterinary manual (11th ed., pp. 1584–1729). Kenilworth: Merck and Co, Inc.

    Google Scholar 

  • Ankel-Simmons, F. (2000). Primate anatomy an introduction (2nd ed.). San Diego: Academic Press.

    Google Scholar 

  • AVMA (American Veterinary Medical Association). (2007). AVMA guidelines on euthanasia. Schaumburg: AVMA.

    Google Scholar 

  • Berringer, O. M., Browning, F. M., & Schroeder, C. R. (1968). An atlas and dissection manual of rhesus monkey anatomy. Tallahassee: Anatomy Laboratory Aids.

    Google Scholar 

  • Bessis, M. (1976). Blood smears reinterpreted (Vol. 10, pp. 217–236). Translated by George Brecher (1977). Springer: New York.

    Google Scholar 

  • Bregman, C. L., Adler, R. R., Morton, D. G., Regan, K. S., & Yano, B. L. (2003). Recommended tissue list for histopathologic examination in repeat-dose toxicity and carcinogenicity studies: A proposal of the Society of Toxicologic Pathology (STP). Toxicologic Pathology, 31, 252–253.

    CAS  PubMed  Google Scholar 

  • Bucci, T. J. (2002). Basic techniques. In W. M. Haschek, C. G. Rousseaux, & M. A. Wallig (Eds.), Handbook of toxicologic pathology (Vol. I, 2nd ed., pp. 171–186). Orlando: Elsevier Press.

    Google Scholar 

  • Carson, F. L. (1997). Histotechnology: A self-instructional text (2nd ed.). Chicago: American Society of Clinical Pathologists.

    Google Scholar 

  • Compton, S. R., & Riley, L. K. (2001). Detection of infectious agents in laboratory rodents: Traditional and molecular techniques. Comparative Medicine, 51, 113–133.

    CAS  PubMed  Google Scholar 

  • Cooper, E. C. (1994). Animal facilities. In E. C. Cooper (Ed.), Laboratory design handbook (pp. 99–110). Boca Raton: CRC Press.

    Google Scholar 

  • Culling, C. F. A., Allison, R. T., & Barr, W. T. (1985). Cellular pathology technique (4th ed.). London: Butterworths.

    Google Scholar 

  • Doerning, B. J., & Cruze, C. (1997). The effects of routine animal husbandry and experimental procedures upon physiological parameters of rats. In Abstracts of Scientific Papers, Platform and Poster Presentations, 1997 AALAS National Meeting. Anaheim.

    Google Scholar 

  • Dorland, W. A. N. (Ed.). (1994). Dorland’s illustrated medical dictionary (28th ed., p. 1103). Philadelphia: W.B. Saunders Company, 1244.

    Google Scholar 

  • Edwards, W. D. (1988). Photography of medical specimens: Experiences from teaching cardiovascular pathology. Mayo Clinic Proceedings, 63, 42–52.

    CAS  PubMed  Google Scholar 

  • Elvang, H. (2011). Necropsy. A handbook and atlas (1st ed.). Copenhagen: Samfundslitteratur.

    Google Scholar 

  • Everitt, J. I., & Gross, E. A. (2006). Euthanasia and necropsy (Chapter 20). In M. A. Suckow, S. H. Weisbroth, & C. L. Franklin (Eds.), The laboratory rat (2nd ed., pp. 665–678). Burlington: Elsevier Academic Press.

    Google Scholar 

  • Feinstein, R. E., & Waggie, K. S. (2011). Post mortem procedures (Chapter 21). In J. Hau & S. J. Schapiro (Eds.), Handbook of laboratory animal science, Volume I: Essential principles and practices (3rd ed., pp. 613–634). Boca Raton: CRO Press.

    Google Scholar 

  • Feldman, D. B., & Seely, J. C. (1988). Necropsy guide : Rodents and the rabbit (1st ed.). Boca Raton, FL: CRC Press.

    Google Scholar 

  • Gad, S. C. (2017a). The drug development process and the global pharmaceutical marketplace. In Drug safety evaluation (3rd ed., pp. 1–12). Hoboken: Wiley.

    Google Scholar 

  • Gad, S. C. (2017b). Regulation of human pharmaceutical safety: Routes to human use and market. In Drug safety evaluation (3rd ed., pp. 13–58). Hoboken: Wiley.

    Google Scholar 

  • Gad, S. C. (2017c). Nonclinical manifestations, mechanisms, and end points of drug toxicity. In Drug safety evaluation (3rd ed., pp. 115–128). Hoboken: Wiley.

    Google Scholar 

  • Gad, S. C. (2017d). Repeat-dose toxicity studies. In Drug safety evaluation (3rd ed., pp. 159–168). Hoboken: Wiley.

    Google Scholar 

  • Getty, R. (1975a). Sisson and Grossman’s the anatomy of the domestic animals (Vol. I, 5th ed.). Philadelphia: W. B. Saunders.

    Google Scholar 

  • Getty, R. (1975b). Sisson and Grossman’s the anatomy of the domestic animals (Vol. II, 5th ed.). Philadelphia: W. B. Saunders.

    Google Scholar 

  • Gilbert, S. G. (1968). Pictorial anatomy of the cat (Rev. ed.). Seattle: University of Washington Press.

    Google Scholar 

  • Goldenthal, E. (1968). Current view on safety evaluation of drugs. FDA Papers, pp. 13–18.

    Google Scholar 

  • Gray, H. (1985). Anatomy of the human body. C. D. Clemente (Ed.), (Thirtieth American ed., 1–18, 1–1608). Philadelphia: Lea & Febiger.

    Google Scholar 

  • Haschek, W. M., Rousseaux, C. G., & Wallig, M. A. (2002). Toxicologic pathology: An introduction. In W. M. Haschek, C. G. Rousseaux, & M. A. Wallig (Eds.), Handbook of toxicologic pathology (Vol. I, 2nd ed., pp. 3–14). Orlando: Elsevier Press.

    Google Scholar 

  • Hastings, K. L. (2007). Nonclinical safety evaluation of biotechnology-derived pharmaceuticals. FDA. www.fda.gov

  • Hellebrekers, L. J., & Hedenqvist, P. (2011). Laboratory animal analgesia, anesthesia, and euthanasia (Chapter 17). In J. Hau & S. J. Schapiro (Eds.), Handbook of laboratory animal science, Volume I: Essential principles and practices (3rd ed., pp. 485–534). Boca Raton: CRO Press.

    Google Scholar 

  • ICH. (1997). S6 Preclinical safety evaluation of biotechnology-derived pharmaceuticals.

    Google Scholar 

  • ICH. (2008a). M3 (R2) Nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals.

    Google Scholar 

  • ICH. (2008b). M3 (R2) Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.

    Google Scholar 

  • Kiernan, J. A. (2000). Formaldehyde, formalin, paraformaldehyde and glutaraldehyde: What they are and what they do. Microcoscopy Today, 00-1, pp. 8–12. Miami: Today Enterprises.

    Google Scholar 

  • King, J. M., Dodd, D. C., Roth, L., & Newson, M. E. (1989). The necropsy book. Gurnee: Charles Louis Davis, DVM Foundation.

    Google Scholar 

  • Maggs, D. J., Miller, P. E., & Ofri, R. (2008). Slatter’s fundamentals of veterinary ophthalmology (4th ed.). St. Louis: Saunders Elsevier.

    Google Scholar 

  • Mathieu, M. (2000). New drug development: A regulatory overview (5th ed.). Waltham: Parexal.

    Google Scholar 

  • Mathieu, M. (2005). New drug development: A regulatory overview (7th ed.). Waltham: Parexal.

    Google Scholar 

  • Mayer, L. (1995). Animal facility criteria. In L. Mayer (Ed.), Design and planning of research and clinical laboratory facilities (pp. 161–186). New York: Wiley.

    Google Scholar 

  • McGavin, M. D. (1988). Specimen dissection and photography: For the pathologist, anatomist and biologist. Springfield: Charles C. Thomas, Ltd.

    Google Scholar 

  • McMenamine, P. G. (2000). Optimal methods for preparation and immunostaining of iris, ciliary body and choroidal wholemounts. Investigative Ophthalmology & Visual Science, 41(10), 3043–3048.

    Google Scholar 

  • Mehendale, H. M. (2008). Application of isolated organ perfusion techniques in toxicology. In A. W. Hayes (Ed.), Principles and methods of toxicology (5th ed., pp. 1865–1922). Boca Raton: CRC Press.

    Google Scholar 

  • Morton, D., Kemp, R. K., Francke-Carroll, S., Jensen, K., McCartney, J., Monticello, T. M., Perry, R., Pulido, O., Roome, N., Schafer, K., Sellers, R., & Snyder, P. W. (2006). Society of Toxicologic Pathology Position Paper: Best practices for reporting pathology interpretations within GLP toxicology studies. Toxicologic Pathology, 34, 806–809.

    PubMed  Google Scholar 

  • Morton, D., Sellers, R., Barale-Thomas, E., Bolon, B., George, C., Hardisty, J. F., Irizarry, A., McKay, J. S., Odin, M., & Teranishi, M. (2012). Society of Toxicologic Pathology. http://www.toxpath.org: Best practices.

  • Nickel, R., Schummer, A., Seiferle, E., Frewein, J., Wilkens, H., & Wille, K-H. (1986). The anatomy of the domestic animals. Volume I: The Locomotor system of the domestic mammals. (Translated by Walter G. Siller and William M. Stokoe) (Founded by Richard Nickel, August Schummer, and Eugen Seiferle). Berlin: Verlag Paul Parey/New York: Springer.

    Google Scholar 

  • NRC (National Research Council). (2011). Chapter 3, 56–70. Veterinary care. In Guide for the care and use of laboratory animals (8th ed.). Washington, DC: The National Academies Press.

    Google Scholar 

Other Readings

  • Parkinson, C. M., O’Brien, A., Albers, T. M., Simon, M. A., Clifford, C. B., & Pritchett-Corning, K. R. (2011). Diagnostic necropsy and selected tissue and sample collection in rats and mice. Journal of Visualized Experiments (JoVE), (54), e2966. https://doi.org/10.3791/2966, Boston, MA.

  • Popesko, P., Rajtova, V., & Horak, J. (1992a). A colour atlas of the anatomy of small laboratory animals. Volume one (rabbit and guinea pig). London: Wolfe Publishing, Ltd.

    Google Scholar 

  • Popesko, P., Rajtova, V., & Horak, J. (1992b). A colour atlas of the anatomy of small laboratory animals. Volume two (rat, mouse and golden hamster). London: Wolfe Publishing, Ltd.

    Google Scholar 

  • Preece, A. (1972). A manual for histologic technicians (3rd ed.). La Jolla: Little Brown.

    Google Scholar 

  • Rang, H. P. (2006). Drug discovery and development. Edinburgh: Churchill Livingstone.

    Google Scholar 

  • Rostgaard, J., Qvortrup, K., & Poulsen, S. (1993). Improvements in the technique of vascular perfusion-fixation employing a fluorocarbon-containing perfusate and a peristaltic pump controlled by pressure feedback. Journal of Microscopy, 172, 137–151.

    CAS  PubMed  Google Scholar 

  • Saikia, B., Gupta, K., & Saikia, U. M. (2008). The modern histopathologist: In the changing face of time. Diagnostic Pathology, 25, 3–10.

    Google Scholar 

  • Schummer, A. (1977). The anatomy of the domestic animals. Volume IV: Anatomy of the domestic birds. (Translated by Walter G. Siller and Peter A. L. Wright) (Founded by Richard Nickel, August Schummer, and Eugen Seiferle). Berlin: Verlag Paul Parey/New York: Springer.

    Google Scholar 

  • Schummer, A., Nickel, R., & Sack, W. O. (1979). The anatomy of the domestic animals. Volume II: The viscera of the domestic mammals. (Translated by Walter G. Siller and William M. Stokoe) (Founded by Richard Nickel, August Schummer, and Eugen Seiferle). Berlin: Verlag Paul Parey/New York: Springer.

    Google Scholar 

  • Schummer, A., Wilkens, H., Vollmerhaus, B., & Habermehl, K-H. (1981). The anatomy of the domestic animals. Volume III: The circulatory system, the kin, and the cutaneous organs of the domestic mammals. (Translated by Walter G. Siller and Peter A. L. Wight) (Founded by Richard Nickel, and August Schummer). Berlin: Verlag Paul Parey/New York: Springer.

    Google Scholar 

  • Scouten, C. W., O’Connor, R., & Cunningham, M. (2006). Perfusion fixation of research animals. Microscopy Today, 14, 26–33.

    Google Scholar 

  • Sellers, R. S., Morton, D., Michael, B., Roome, N., Johnson, J. K., Yano, B. L., Perry, R., & Schafer, K. (2007). Society of Toxicologic Pathology position paper: Organ weight recommendations for toxicology studies. Toxicologic Pathology, 35, 751–755.

    PubMed  Google Scholar 

  • Simmons, M. M., Blamire, I. W., & Austin, A. R. (1996). Simple method for the fixation of adult bovine brain. Research in Veterinary Science, 60(3), 247–250.

    CAS  PubMed  Google Scholar 

  • Slatter, D. (1993). Textbook of small animal surgery (Vol. I, 3rd ed.). Philadelphia: W. B. Saunders.

    Google Scholar 

  • Slatter, D. (2001). Fundamentals of veterinary ophthalmology (3rd ed.). Philadelphia: W. B. Saunders.

    Google Scholar 

  • Spector, D. L., & Goldman, R. D. (2005). Basic methods in microscopy: Protocols and concepts from cells: A laboratory manual. Cold Spring Harbor: Cold Spring Harbor Laboratory Press.

    Google Scholar 

  • Stack, L. B., Storrow, A. B., Morris, M. A., & Patton, D. R. (2001). Handbook of medical photography. Philadelphia: Hanley & Belfus.

    Google Scholar 

  • Stickrod, G., & Stansifer, M. (1981). Perfusion of small animals using a mini-peristaltic pump. Physiology & Behavior, 27(6), 1127–1128.

    CAS  Google Scholar 

  • Strafuss, A. C. (1988). Necropsy procedures and basic diagnostic methods for practicing veterinarians. Springfield: Charles C. Thomas.

    Google Scholar 

  • Stretch, G. L., Nation, R. L., Evans, A. M., & Milne, R. W. (1999). Organ perfusion techniques in drug development. Drug Development Research, 46, Wiley, New York, 3–4.

    Google Scholar 

  • The Society of Toxicologic Pathologists. (1997). Position paper of the Society of Toxicologic Pathologists: Documentation of pathology peer review. Toxicologic Pathology, 25(6), 655.

    Google Scholar 

  • The Society of Toxicologic Pathologists. (1991). Peer review in toxicologic pathology: Some recommendations. Toxicologic Pathology, 19(3), 290–292.

    Google Scholar 

  • Tuomari, D. L., Kemp, R. K., Sellers, R., Yarrington, J. T., Geoly, F. J., Fouillet, X. L., Dybdal, N., Perry, R., & Long, P. (2007). Society of Toxicologic Pathology position paper on pathology image data: Compliance with 21 CFR Parts 58 and 11. Toxicologic Pathology, 35, 450–455.

    PubMed  Google Scholar 

  • U.S. Food and Drug Administration (FDA). (1988). Good laboratory practices. CFR 21 Part 58, April 1988.

    Google Scholar 

  • U. S. Food and Drug Administration (FDA). (2000). Redbook 2000: Guidance for industry and other stakeholders toxicological principles for the safety assessment of food ingredients Redbook 2000. Chapter IV.B.3. Pathology considerations in toxicity studies, July 2000.

    Google Scholar 

  • Weinberg, D. S. (1997). Digital imaging as a teaching tool for pathologists. Clinics in Laboratory Medicine, 17, 229–239.

    CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Spainhour Consulting Services, Scott Township, PA, USA

    Charles B. Spainhour

  2. Gad Consulting, Cary, NC, USA

    Shayne C. Gad

Authors
  1. Charles B. Spainhour
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Shayne C. Gad
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Spainhour, C.B., Gad, S.C. (2020). The Inner Cro: Pathology – Necropsy and Gross Pathology. In: Contract Research and Development Organizations-Their History, Selection, and Utilization. Springer, Cham. https://doi.org/10.1007/978-3-030-43073-3_10

Download citation

Publish with us

Policies and ethics

Search

Navigation