METHODS AND SYSTEMS USING INTEGRATED METABOLOMICS AND PHARMACOKINETICS FOR MULTI-COMPONENT DRUG EVALUATION
First Claim
1. A method of identifying biochemical changes in a subject in response to administration of a multi-component therapeutic and one or more active ingredients in the multi-component therapeutic comprising:
- (a) determining a component profile for the multi-component therapeutic,(b) determining a pre-administration metabolome in a subject sample before administration of the multi-component therapeutic;
(c) determining a post-administration metabolome in a subject sample after administration of the multi-component therapeutic;
(d) comparing the component profile for the multi-component therapeutic to the subject'"'"'s post-administration metabolome, wherein shared components are absorbed components from the multi-component therapeutic by the subject;
(e) comparing the subject'"'"'s pre-administration metabolome to the subject'"'"'s post-administration metabolome, wherein shared components are altered endogenous components that are differentially expressed by administration of the multi-component therapeutic;
wherein components in the subject'"'"'s post-administration metabolome that are not absorbed components or altered endogenous components are metabolized and/or biotransformed components; and
wherein the absorbed components, metabolized and/or biotransformed components and the altered endogenous components are used to characterize the biochemical changes in the subject in response to active ingredients in the multi-component therapeutic
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Accused Products
Abstract
Disclosed are methods and systems for identifying biochemical changes in a subject in response to administration of a multi-component therapeutic and one or more active ingredients in the multi-component therapeutic. The methods and systems of the invention may be used to elucidate the interaction of the biological system'"'"'s genome with its environments, and in the pharmacokinetic, pharmacodynamic and toxicology analysis of multi-component therapeutics. The metabolomics methods and systems of the invention can also be used in studies of plant derived agents to demonstrate biochemical alterations in response to the dynamic multi-component intervention.
18 Citations
24 Claims
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1. A method of identifying biochemical changes in a subject in response to administration of a multi-component therapeutic and one or more active ingredients in the multi-component therapeutic comprising:
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(a) determining a component profile for the multi-component therapeutic, (b) determining a pre-administration metabolome in a subject sample before administration of the multi-component therapeutic; (c) determining a post-administration metabolome in a subject sample after administration of the multi-component therapeutic; (d) comparing the component profile for the multi-component therapeutic to the subject'"'"'s post-administration metabolome, wherein shared components are absorbed components from the multi-component therapeutic by the subject; (e) comparing the subject'"'"'s pre-administration metabolome to the subject'"'"'s post-administration metabolome, wherein shared components are altered endogenous components that are differentially expressed by administration of the multi-component therapeutic; wherein components in the subject'"'"'s post-administration metabolome that are not absorbed components or altered endogenous components are metabolized and/or biotransformed components; and wherein the absorbed components, metabolized and/or biotransformed components and the altered endogenous components are used to characterize the biochemical changes in the subject in response to active ingredients in the multi-component therapeutic - View Dependent Claims (2, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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3-5. -5. (canceled)
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23. A system to identifying biochemical changes in a subject in response to administration of a multi-component therapeutic and one or more active ingredients in the multi-component therapeutic comprising:
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(a) a part for determining a component profile for the multi-component therapeutic, a pre-administration metabolome in a subject sample before administration of the multi-component therapeutic, and a post-administration metabolome in a subject sample after administration of the multi-component therapeutic; (b) a part for comparing the component profile for the multi-component therapeutic, the pre-administration metabolome in a subject sample before administration of the multi-component therapeutic, and the post-administration metabolome in a subject sample after administration of the multi-component therapeutic;
wherein comparison of results in identification of absorbed components, the altered endogenous metabolites and the metabolized and/or biotransformed components; and(c) a part for analyzing correlations between the absorbed components, the altered endogenous metabolites and the metabolized and/or biotransformed components, wherein correlations between the absorbed components, the metabolized and/or biotransformed components and the altered endogenous components are used to characterize the biochemical changes in the subject in response to active ingredients in the multi-component therapeutic
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24-44. -44. (canceled)
Specification