Active metabolite definition
Active metabolite - Wikipedia
An active metabolite may bind to the therapeutic target receptors or other receptors, interact with other targets (e.g., enzymes, proteins), and cause unintended effects.
Guidance for Industry
tic model that can be used to predict metabolite-to-parent drug ratios are presented. Final equations are built starting with basic clearance concepts9 and the contribution of gut to metabolite formation has been added. The extended clearance concept10 that also includes active transport as an important determinant in drug and metabolite ...
[PDF File]5. Prodrug Metabolism (2013) - University of Washington
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(drug or metabolite) is attached to an ionisable grouping. This is called conjugation and the product is called a conjugate. Metabolites formed in phase 2 are unlikely to be pharmacologically active. Phase 1 and/or phase 2 Some drugs undergo either phase 1 or phase 2 metabolism, but most undergo phase 1
[PDF File]Pharmacokinetic processes: metabolism - STEM
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metabolites included in the plant residue definitions and one soil metabolite in relation to the parent metobromuron. In the residues section, the consumer risk assessment should be considered provisional pending the outcome of the requested toxicological information on the metabolites included in the plant residue definitions.
Conclusion on the peer review of the pesticide risk ...
Introduction to Pharmacokinetics and Pharmacodynamics Pharmacokinetics is currently defined as the study of the time course of drug absorption, distribution, metabo-lism, and excretion. Clinical pharmacokinetics is the application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient.
[PDF File]Safety Testing of Drug Metabolites Guidance for Industry
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metabolite to the overall effects of the adminis-tered opioid. In all cases of active metabo-lites, the clinical consequences also depend on the nature of the metabolite’s effects, namely, on whether the metabolite is an opioid and contributes to the clinical effects by …
Opioid Metabolites
multiple-dose study is desirable when the drug or an active metabolite is known to exhibit nonlinear or time-dependent PK. In single-dose studies, the same dose can usually be administered to all ...
Prediction of Metabolite‐to‐Parent Drug Exposure ...
Category definition This is a procedure for finding analogues accounting for metabolic transformation of the chemicals. Toolbox allows finding analogues that have: • parent and its metabolites with defined profile • metabolite with defined profile • exact metabolite • metabolite with defined parameter value • metabolite similar to ...
[PDF File]Outline Revised guideline on bioequivalence
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5. Prodrug Metabolism (2013) Prodrug Definition: Strict Definition: Prodrugs are inactive drugs that undergo a chemical or biochemical conversion to the active drug. Prodrug Biochemical or chemical process(es) Drug inactive active The definition of a prodrug is controversial in some circles. 1.
[PDF File]QSAR Toolbox functionalities. Category definition by ...
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Other issues • Single vs multiple dose study • Active metabolite in addition to parent • Prodrugs: inactive parent or active metabolite • Definition of linearity/non-linearity
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