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Published on: March 21, 2021
Cracking the Egg: Potential of the Developing Chicken as a Model System for Nonclinical Safety Studies of
Sigrid Bjørnstad1, Lars Peter Engeset Austdal1, Borghild Roald1
1Department 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.).
Insights
The developing chicken embryo offers a cost-effective, accessible model for nonclinical drug safety studies, evaluating cardiovascular, respiratory, and central nervous system effects in early pharmaceutical development.
Area of Science:
- Pharmacology
- Toxicology
- Developmental Biology
Background:
- Perinatal medicine advances increase survival of extremely premature infants, creating a vulnerable patient group needing safe medication options.
- Drug safety studies have historically excluded fetal and neonatal populations, posing risks for medication use during pregnancy and in newborns.
- Regulatory bodies like the FDA and EMA are promoting expanded safe pharmacological treatments for these populations, emphasizing neonate inclusion in clinical trials.
Purpose of the Study:
- To review the potential and limitations of the developing chicken embryo as an animal model for nonclinical drug safety testing.
- To assess the suitability of the chicken embryo model for evaluating drug effects on major organ systems relevant to neonatal safety.
Main Methods:
- Review of existing guidelines for nonclinical drug safety testing, including International Conference on Harmonization M3 (R2).
- Evaluation of the developing chicken embryo's biological features relevant to pharmacology and toxicology studies.
- Comparison of the chicken embryo model with other high-throughput models like human stem cells, Caenorhabditis elegans, and zebrafish.
Main Results:
- The chicken embryo/fetus possesses features making it a convenient model for assessing drug effects on cardiovascular, respiratory, and central nervous systems.
- Advantages include low cost, accessibility, nutritional self-sufficiency, and a short incubation period, ideal for drug screening.
- Alternative models like human stem cells and zebrafish have limitations in mimicking human physiology or specific organ system development.
Conclusions:
- The developing chicken embryo presents a valuable, cost-effective model for the early exploratory phase of pharmaceutical development.
- It can aid in assessing drug safety across critical organ systems prior to more complex or human-based studies.
- Further utilization of this model can contribute to expanding safe medication options for pregnant women and newborns.
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.
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