Why animal studies are often poor predictors of human reactions to                exposure

Bracken, Michael B.

doi:10.1258/jrsm.2008.08k033

Cited by 300 publications

(203 citation statements)

References 23 publications

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“…In particular, both EU and FDA legislation require drugs to be tested on animals before reaching the market. However, given that most physiological and pathological processes are significantly different in humans and animals, and that drugs are given to sick, often old humans but tested on healthy and young animals, the utility of this type of regulatory testing, and the use of animals as human-surrogates in general, has recently been questioned [7,8].…”

Section: Figure 1 Applications Of In Vitro Modelsmentioning

confidence: 99%

Design Criteria for Generating Physiologically Relevant In Vitro Models in Bioreactors

2014

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Abstract:In this paper, we discuss the basic design requirements for the development of physiologically meaningful in vitro systems comprising cells, scaffolds and bioreactors, through a bottom up approach. Very simple micro-and milli-fluidic geometries are first used to illustrate the concepts, followed by a real device case-study. At each step, the fluidic and mass transport parameters in biological tissue design are considered, starting from basic questions such as the minimum number of cells and cell density required to represent a physiological system and the conditions necessary to ensure an adequate nutrient supply to tissues. At the next level, we consider the use of three-dimensional scaffolds, which are employed both for regenerative medicine applications and for the study of cells in environments which better recapitulate the physiological milieu. Here, the driving need is the rate of oxygen supply which must be maintained at an appropriate level to ensure cell viability throughout the thickness of a scaffold. Scaffold and bioreactor design are both critical in defining the oxygen profile in a cell construct and are considered together. We also discuss the oxygen-shear stress trade-off by considering the levels of mechanical stress required for hepatocytes, which are the limiting cell type in a multi-organ model. Similar considerations are also made for glucose consumption in cell constructs. Finally, the allometric approach for generating multi-tissue systemic models using bioreactors is described.

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Section: Figure 1 Applications Of In Vitro Modelsmentioning

confidence: 99%

Design Criteria for Generating Physiologically Relevant In Vitro Models in Bioreactors

2014

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“…One of the few systematic comparisons of drug studies done in animals and humans showed substantial discordance, which the authors of the study attributed either to bias or to the failure of animal models to mimic clinical disease adequately. 12,13 …”

Section: '1 the Drug Must Be Free From Any Acquired Quality: This Camentioning

confidence: 99%

Ibn Sina's Canon of Medicine: 11th century rules for assessing the effects of drugs

2009

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“…The diffi culty to extrapolate animal experimental results to humans has been described in the 11 th Century by the Persian polymath Ibn-Sina / Avicena (980-1037) [87,88], and by the English poet Alexander Pope (1688-1744) in his quote "the proper study of mankind is man", published in 1733-1734 in the An Essay on Man [98,99].…”

Section: Discussionmentioning

confidence: 99%

Bilateral Common Carotid Artery Ligation in Sheep. Could These Animals be Used as Human Models for Vascular and Cerebral Research?

2017

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Experimental animals are still used in today's medicine to understand better physiological or pathological processes, or to develop, for example better vascular prostheses. For that reason, these animals must show some similarities with humans, from the anatomical to the physiological point of view.When developing vascular prostheses, we have to evaluate if the graft will react in the expected way and if during experimental research there will be some factors that might infl uence the proper functioning of vascular prostheses in the human body.We observed the consequences of bilateral common carotid artery ligation (BCCAL) or Sham operation in seventeen healthy Merinolandschaf / Württemberg sheep, aged between 2 and 4 years, after testing new types of carbon-coated ARTECOR® and ADIPOGRAFT Ra 1vk 7/350 vascular prostheses. After the follow-up period the prostheses were extirpated, so the blood supply was provided from the vertebral arteries.Sheep in both groups were not sacrifi ced, but were observed for 18 months. After the observation period all sheep showed no physical or neurological changes and all are still alive. Animal responses to BCCAL are different, depending on the animal species, age, and condition. In sheep, bilateral blocking of the blood fl ow in the carotid bed seems to be conceivable since the brain was suffi ciently supplied with blood from the vertebral arteries.

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Why animal studies are often poor predictors of human reactions to exposure

Cited by 300 publications

References 23 publications

Design Criteria for Generating Physiologically Relevant In Vitro Models in Bioreactors

Design Criteria for Generating Physiologically Relevant In Vitro Models in Bioreactors

Ibn Sina's Canon of Medicine: 11th century rules for assessing the effects of drugs

Bilateral Common Carotid Artery Ligation in Sheep. Could These Animals be Used as Human Models for Vascular and Cerebral Research?

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