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The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
The plateau principle is a mathematical model or scientific law originally developed to explain the time course of drug action (pharmacokinetics). [1] The principle has wide applicability in pharmacology, physiology, nutrition, biochemistry, and system dynamics.
The action of drugs on the human body (or any other organism's body) is called pharmacodynamics, and the body's response to drugs is called pharmacokinetics. The drugs that enter an individual tend to stimulate certain receptors, ion channels, act on enzymes or transport proteins. As a result, they cause the human body to react in a specific way.
The mechanism of action is a crucial factor in determining effect and toxicity of the drug, taking in consideration the pharmacokinetic (PK) factors. [12] The sort and extent of altered cellular physiology will depend on the combination of the drug's presence (as established by pharmacokinetic (PK) studies) and/or its mechanism and duration of ...
Beta phase: A phase of gradual decrease in plasma concentration after the alpha phase. The decrease is primarily attributed to drug elimination, that is, metabolism and excretion. [10] Additional phases (gamma, delta, etc.) are sometimes seen. [11] A drug's characteristics make a clear distinction between tissues with high and low blood flow.
The trials are typically conducted in three phases: [5] Phase 1: The drug is tested in 20 to 100 healthy volunteers to determine its safety at low doses. About 70% of candidate drugs advance to Phase 2. Phase 2: The drug is tested for both efficacy and safety in up to several hundred people with the targeted disease.
An example of this is the repurposing of the antimineralocorticoid and diuretic spironolactone, which was found to produce feminization and gynecomastia as side effects, for use as an antiandrogen in the treatment of androgen-dependent conditions like acne and hirsutism in women. [1] Metformin also causes off-target activity. [citation needed]
In pharmacology, biological activity or pharmacological activity describes the beneficial or adverse effects of a drug on living matter. [1] [2] When a drug is a complex chemical mixture, this activity is exerted by the substance's active ingredient or pharmacophore but can be modified by the other constituents. Among the various properties of ...