Animal models ethical issues

Ethical issues as well as difficulty in obtaining enough human nasal tissue specimens have called for the need to use alternative in vitro and in vivo methods. Various in vivo animal models and in vitro excised tissue models have been described in the literature for nasal drug transport studies. However, due to the difficulty in both controlling the experimental conditions in in vivo animal models and obtaining intact excised tissue samples, in vitro cell culture models are also being actively developed. 

Animal Models and Human Drug Use Human Behavioral Pharmacology Ethical Issues Placebo Controls New Drug Development... 

Whole animal models and traditional cell culture models have been the primary mode of validation for this purpose. However, animal models are subject to significant expense, lengthy experiments, ethical issues, and it is often difficult to extrapolate results from animals directly to effects on human beings. Results from traditional in vitro cell culture are of limited usefulness due to the difficulty sustaining in vivo functions of primary cells as an isolated, static system [95],... 

However, there are serious ethical issues associated with these types of animal model experiment. A careful balance is needed to weight pros and cons. Some of the concerns voiced are reflected in an editorial posted on the website of Santa Clara University, Santa Clara, CA as follows (Andre and Velasquez, 1988 see also Rollin, 2012) ... 

From 1984 to 1997,1 was the director of computer systems in the Clinical Research Center (CRC) at Vanderbilt. I became aware of many ethical issues that I had not been forced to confront when my focus was on animal studies and mathematical models of research, including ... 

The introduction of a product designed for implantation into humans requires a comprehensive development program, structured to address issues of potential toxicity, safety, and efficacy in vitro, followed by preclinical in vivo testing in appropriate animal models. Only after safety and efficacy are established, can human trials be considered. Since the employment of the NovoSorb biodegradable polyurethane platform was entirely novel in both material and concept, we followed this strategy. All trial proposals were submitted to, and approved by, the relevant Animal or Human Research Ethics Conunittee. 

Living animal models Realism, mimic complications, different anatomy from human, ethical issues, high costs Soft tissue and vessel preparation, performance of vascular anastomoses, damage control... 

In in vivo studies, an important issue is the quality of ECG recordings and the methods used for the analysis. A few years ago, a survey reported on the practice in the pharmaceutical industry to assess the potential for QT prolongation and concluded that the majority view in the industry is not necessarily best practice [153]. After this publication, a lot of work has been done to improve the performance of in vivo models, although it should be acknowledged that their cost (together with some ethical considerations on the rational use of animals) makes them unsuitable for large-scale screening. 

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