Phase Iv Of The Phase II And Phase IIi

1443 Words Nov 26th, 2015 6 Pages
Phase IV Studies
Before describing about how Phase IV studies is differ from the Phase II and Phase III trial, I would like to explain about how Phase I to Phase III Clinical trial is conducted.
How Phase IV studies differ from Phase II and III studies?
In Phase I study the safety of a drug or device is a priority and this initial testing phase can take several months to complete and generally includes 20 to 100 paid healthy volunteers in study. The design of the study is to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. The investigation of a side effects also observed by an increasing the drug doses. Not all drugs are passing during this phase, but nearly 70% of experimental drugs pass during this phase of testing.
Phase II studies test is conducted for the efficacy of a drug or device. This second phase of testing involves up to several hundred patients and can last from several months to two years. Most phase II studies are designed on randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. This is a blind study which means that neither the patients nor the researchers know who has received the experimental drug and who has received the placebo. Investigators get information about new drug safety and effectiveness to provide to the pharmaceutical company and the FDA .About one-third of experimental drugs…

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