Ex vivo methods for validating substance testing with human organs and/or tissues
First Claim
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1. A method of validating results of substance testing using at least one human organ or tissue selected from the group consisting of a metabolically active human organ or tissue that has been permanently removed from its origin and an engineered organ or tissue derived from isolated and/or cultured human cells, comprising:
- (a) assessing said human organ or tissue for suitability for testing prior to administration of a test substance;
(b) perfusing said organ or tissue with a perfusate containing said test substance;
(c) assessing a parameter relating to said test substance; and
(d) assessing said organ or tissue for suitability for testing of said parameter relating to said test substance during and/or after administration of said test substance.
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Abstract
Methods of validating results of assessments of test substances using human-derived tissues and/or organs, particularly tissues and/or organs unsuitable for transplantation, include assessing the suitability of the organ and/or tissue for substance testing, as well as inter-organ variability and use of exogenous and/or endogenous controls.
42 Citations
48 Claims
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1. A method of validating results of substance testing using at least one human organ or tissue selected from the group consisting of a metabolically active human organ or tissue that has been permanently removed from its origin and an engineered organ or tissue derived from isolated and/or cultured human cells, comprising:
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(a) assessing said human organ or tissue for suitability for testing prior to administration of a test substance; (b) perfusing said organ or tissue with a perfusate containing said test substance; (c) assessing a parameter relating to said test substance; and (d) assessing said organ or tissue for suitability for testing of said parameter relating to said test substance during and/or after administration of said test substance. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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Specification