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Research ArticleMinireview

Cracking the Egg: Potential of the Developing Chicken as a Model System for Nonclinical Safety Studies of Pharmaceuticals

Sigrid Bjørnstad, Lars Peter Engeset Austdal, Borghild Roald, Joel Clinton Glover and Ragnhild Elisabeth Paulsen
Journal of Pharmacology and Experimental Therapeutics December 2015, 355 (3) 386-396; DOI: https://doi.org/10.1124/jpet.115.227025
Sigrid Bjørnstad
Department of Pathology, Oslo University Hospital HF, Ullevål, Oslo, Norway (S.B., B.R.); Institute of Clinical Medicine (B.R.), Department of Pharmaceutical Biosciences, School of Pharmacy (L.P.E.A., R.E.P.), and NDEVOR, Section of Physiology, Department of Molecular Medicine, Institute of Basic Medical Sciences (J.C.G.), University of Oslo, Oslo, Norway; and Norwegian Center for Stem Cell Research, Department of Immunology and Transfusion Medicine, Oslo University Hospital HF, Rikshospitalet, Oslo, Norway (J.C.G.)
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Lars Peter Engeset Austdal
Department of Pathology, Oslo University Hospital HF, Ullevål, Oslo, Norway (S.B., B.R.); Institute of Clinical Medicine (B.R.), Department of Pharmaceutical Biosciences, School of Pharmacy (L.P.E.A., R.E.P.), and NDEVOR, Section of Physiology, Department of Molecular Medicine, Institute of Basic Medical Sciences (J.C.G.), University of Oslo, Oslo, Norway; and Norwegian Center for Stem Cell Research, Department of Immunology and Transfusion Medicine, Oslo University Hospital HF, Rikshospitalet, Oslo, Norway (J.C.G.)
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Borghild Roald
Department of Pathology, Oslo University Hospital HF, Ullevål, Oslo, Norway (S.B., B.R.); Institute of Clinical Medicine (B.R.), Department of Pharmaceutical Biosciences, School of Pharmacy (L.P.E.A., R.E.P.), and NDEVOR, Section of Physiology, Department of Molecular Medicine, Institute of Basic Medical Sciences (J.C.G.), University of Oslo, Oslo, Norway; and Norwegian Center for Stem Cell Research, Department of Immunology and Transfusion Medicine, Oslo University Hospital HF, Rikshospitalet, Oslo, Norway (J.C.G.)
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Joel Clinton Glover
Department of Pathology, Oslo University Hospital HF, Ullevål, Oslo, Norway (S.B., B.R.); Institute of Clinical Medicine (B.R.), Department of Pharmaceutical Biosciences, School of Pharmacy (L.P.E.A., R.E.P.), and NDEVOR, Section of Physiology, Department of Molecular Medicine, Institute of Basic Medical Sciences (J.C.G.), University of Oslo, Oslo, Norway; and Norwegian Center for Stem Cell Research, Department of Immunology and Transfusion Medicine, Oslo University Hospital HF, Rikshospitalet, Oslo, Norway (J.C.G.)
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Ragnhild Elisabeth Paulsen
Department of Pathology, Oslo University Hospital HF, Ullevål, Oslo, Norway (S.B., B.R.); Institute of Clinical Medicine (B.R.), Department of Pharmaceutical Biosciences, School of Pharmacy (L.P.E.A., R.E.P.), and NDEVOR, Section of Physiology, Department of Molecular Medicine, Institute of Basic Medical Sciences (J.C.G.), University of Oslo, Oslo, Norway; and Norwegian Center for Stem Cell Research, Department of Immunology and Transfusion Medicine, Oslo University Hospital HF, Rikshospitalet, Oslo, Norway (J.C.G.)
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Abstract

The advance of perinatal medicine has improved the survival of extremely premature babies, thereby creating a new and heterogeneous patient group with limited information on appropriate treatment regimens. The developing fetus and neonate have traditionally been ignored populations with regard to safety studies of drugs, making medication during pregnancy and in newborns a significant safety concern. Recent initiatives of the Food and Drug Administration and European Medicines Agency have been passed with the objective of expanding the safe pharmacological treatment options in these patients. There is a consensus that neonates should be included in clinical trials. Prior to these trials, drug leads are tested in toxicity and pharmacology studies, as governed by several guidelines summarized in the multidisciplinary International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use M3 (R2). Pharmacology studies must be performed in the major organ systems: cardiovascular, respiratory, and central nervous system. The chicken embryo and fetus have features that make the chicken a convenient animal model for nonclinical safety studies in which effects on all of these organ systems can be tested. The developing chicken is inexpensive, accessible, and nutritionally self-sufficient with a short incubation time and is ideal for drug-screening purposes. Other high-throughput models have been implemented. However, many of these have limitations, including difficulty in mimicking natural tissue architecture and function (human stem cells) and obvious differences from mammals regarding the respiratory organ system and certain aspects of central nervous system development (Caenorhabditis elegans, zebrafish).This minireview outlines the potential and limitations of the developing chicken as an additional model for the early exploratory phase of development of new pharmaceuticals.

Footnotes

    • Received July 1, 2015.
    • Accepted October 1, 2015.
  • ↵1 S.B. and L.P.E.A. contributed equally to this work.

  • This work was supported by the Norwegian Research Council [Grant 195484 to J.C.G. and R.E.P.] and Southern and Eastern Norway Regional Health Authority (to B.R.).

  • dx.doi.org/10.1124/jpet.115.227025.

  • Copyright © 2015 by The American Society for Pharmacology and Experimental Therapeutics
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Journal of Pharmacology and Experimental Therapeutics: 355 (3)
Journal of Pharmacology and Experimental Therapeutics
Vol. 355, Issue 3
1 Dec 2015
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Research ArticleMinireview

The Chicken Model for Nonclinical Safety Studies of Drugs

Sigrid Bjørnstad, Lars Peter Engeset Austdal, Borghild Roald, Joel Clinton Glover and Ragnhild Elisabeth Paulsen
Journal of Pharmacology and Experimental Therapeutics December 1, 2015, 355 (3) 386-396; DOI: https://doi.org/10.1124/jpet.115.227025

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Research ArticleMinireview

The Chicken Model for Nonclinical Safety Studies of Drugs

Sigrid Bjørnstad, Lars Peter Engeset Austdal, Borghild Roald, Joel Clinton Glover and Ragnhild Elisabeth Paulsen
Journal of Pharmacology and Experimental Therapeutics December 1, 2015, 355 (3) 386-396; DOI: https://doi.org/10.1124/jpet.115.227025
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  • Article
    • Abstract
    • Introduction
    • Exposure of Pharmaceuticals to the Developing Embryo, Fetus, and Neonate and the Use of Juvenile Animal Models
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