Early Drug Safety Evaluation: Biomarkers, Signatures, and Fingerprints
| Autor: | Ruth A. Roberts, Jean-Charles Gautier, Kelvin Cain, Caroline Freathy, Beth Coyle, Jean-François Léonard |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Drug
Drug-Related Side Effects and Adverse Reactions media_common.quotation_subject Drug Evaluation Preclinical food and beverages Apoptosis Biological activity Protein profile Computational biology Biology Pharmacology Proteomics DNA Fingerprinting Predictive factor Pharmaceutical Preparations Toxicity Animals Humans Pharmacology (medical) General Pharmacology Toxicology and Pharmaceutics Toxicogenomics Biomarkers Target organ media_common |
| Zdroj: | Drug Metabolism Reviews. 35:269-275 |
| ISSN: | 1097-9883 0360-2532 |
| Popis: | When target organ toxicity arises in animal models during routine drug safety evaluation, it raises several key questions: Is this target organ toxicity related to the pharmacology? What is the mode of action (MOA)? Is the target organ toxicity relevant to humans? Pathology or prior knowledge of the compound class may provide clues on a possible MOA for toxicity. However, if this deductive approach yields no results, the inductive approach offered by new technologies can generate novel research leads. For example, toxicogenomics can generate a gene expression profile of the toxicity that can be compared with reference compounds or with other candidate drugs. Similarly, proteomic analysis of the protein profile at the toxic vs. the efficacious dose can provide clues on MOA for the toxicity and may allow differentiation of the pathways of the toxic response from those required for pharmacological activity. |
| Databáze: | OpenAIRE |
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