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For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
Phase II includes a larger number of individual participants in the range of 100–300, and Phase III includes some 1000-3000 participants to assess efficacy and safety of the drug at different doses. [1] [3] [8] Only 25-30% of drugs advance to the end of Phase III. [8]
Refers to the effects of treatment with a drug. If the effects change when the dose of the drug is changed, the effects are said to be dose-dependent. (NCI) Dose-limiting Describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. (NCI) Dose-ranging study
The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) [2] or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). [3] It can also be to investigate a drug ...
The nursing process is a modified scientific method which is a fundamental part of nursing practices in many countries around the world. [1] [2] [3] Nursing practise was first described as a four-stage nursing process by Ida Jean Orlando in 1958. [4] It should not be confused with nursing theories or health informatics. The diagnosis phase was ...
Treatment can be a long process and the duration is dependent upon the patient's needs and history of substance use. Research has shown that most patients need at least three months of treatment and longer durations are associated with better outcomes. [3] Prescription drug addiction does not discriminate.
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Pharmacotherapy, also known as pharmacological therapy or drug therapy, is defined as medical treatment that utilizes one or more pharmaceutical drugs to improve ongoing symptoms (symptomatic relief), treat the underlying condition, or act as a prevention for other diseases (prophylaxis).