Abstract：
Microphysiological systems (MPS) are designed to recapitulate aspects of tissue/organ physiology in vivo, thereby providing potential value in safety and efficacy assessments of FDA-regulated products and regulatory decision-making. While there have been significant advances in the development, use, and proposals of qualification criteria for human organ MPS, there remains a gap in the development using animal tissues. Animal MPS may be of value in many areas including the study of zoonotic diseases, assessment of the safety and efficacy of animal therapeutics, and possibly reduction of the use of animals in regulatory submissions for animal therapeutics. In addition, the development of MPS from various animal species enables comparison to animal in vivo data. This comparison, while not always critical for all contexts of use, could help gain confidence in the use and application of human MPS data for regulatory decision-making and for the potential identification of species-specific effects. The use of animal MPS is consistent with the replacement, reduction, and refinement (3Rs) principles of animal use by identifying toxic compounds before conducting in vivo studies and identifying the appropriate species for testing.
Microphysiological systems (MPS) mimic aspects of organs in humans or animals. These systems may provide information useful for FDA-regulated products. While there have been significant advances in the development of MPS made from human cells, there remains a gap in the development of MPS using animal cells. FDA believes animal MPS may be of value in many areas including the study of diseases transmitted from animals to humans, assessment of the safety and efficacy of animal drugs, and reduction of the use of animals in regulatory submissions. The development of animal MPS enables comparison to data from studies conducted in animals. This comparison provides confidence in the use of human MPS data for regulatory decision-making. The use of animal MPS is consistent with the 3Rs principles of animal use by allowing identification of toxic compounds before conducting animal studies and by helping select the appropriate species for further testing.
Microphysiological systems (MPS) mimic aspects of organs in humans or animals. These systems may provide information useful for FDA-regulated products. While there have been significant advances in the development of MPS made from human cells, there remains a gap in the development of MPS using animal cells. FDA believes animal MPS may be of value in many areas including the study of diseases transmitted from animals to humans, assessment of the safety and efficacy of animal drugs, and reduction of the use of animals in regulatory submissions. The development of animal MPS enables comparison to data from studies conducted in animals. This comparison provides confidence in the use of human MPS data for regulatory decision-making. The use of animal MPS is consistent with the 3Rs principles of animal use by allowing identification of toxic compounds before conducting animal studies and by helping select the appropriate species for further testing.
摘要：
微生理系统（MPS）旨在概括体内组织/器官生理学的各个方面，从而为FDA监管产品的安全性和有效性评估以及监管决策提供潜在价值。虽然发展取得了重大进展，使用,以及人体器官MPS资格标准的建议，使用动物组织的发展仍然存在差距。动物MPS可能在许多领域都有价值，包括人畜共患疾病的研究，评估动物疗法的安全性和有效性，并可能减少在动物治疗的监管提交中使用动物。此外,来自各种动物物种的MPS的开发使得能够与动物体内数据进行比较。这个比较,虽然并不总是对所有使用环境至关重要，可以帮助获得对人类MPS数据的使用和应用的信心，以进行监管决策以及对物种特异性影响的潜在识别。使用动物MPS与替换一致，reduction,和动物使用的细化（3Rs）原则，通过在进行体内研究之前确定有毒化合物并确定合适的物种进行测试。
微生理系统（MPS）模拟人或动物器官的各个方面。这些系统可以提供对FDA监管产品有用的信息。虽然人类细胞MPS的发展取得了重大进展，使用动物细胞开发MPS仍然存在差距。FDA认为动物MPS可能在许多领域都有价值，包括研究从动物传播给人类的疾病，评估动物药物的安全性和有效性，并减少在监管提交中使用动物。动物MPS的开发使得能够与来自在动物中进行的研究的数据进行比较。这种比较为使用人类MPS数据进行监管决策提供了信心。动物MPS的使用与动物使用的3Rs原则一致，允许在进行动物研究之前鉴定有毒化合物，并帮助选择合适的物种进行进一步测试。
微生理系统（MPS）模拟人或动物器官的各个方面。这些系统可以提供对FDA监管产品有用的信息。虽然人类细胞MPS的发展取得了重大进展，使用动物细胞开发MPS仍然存在差距。FDA认为动物MPS可能在许多领域都有价值，包括研究从动物传播给人类的疾病，评估动物药物的安全性和有效性，并减少在监管提交中使用动物。动物MPS的开发使得能够与来自在动物中进行的研究的数据进行比较。这种比较为使用人类MPS数据进行监管决策提供了信心。动物MPS的使用与动物使用的3Rs原则一致，允许在进行动物研究之前鉴定有毒化合物，并帮助选择合适的物种进行进一步测试。
