Phase Iv Of The Phase II And Phase IIi

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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
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Phase III studies conducted on randomized and blind testing based on several hundred to several thousand patients. This large-scale testing, which can last for several years, which provides thorough understanding of the effectiveness of the drug or device to the pharmaceutical company and the FDA with the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is completed, a pharmaceutical company can request to the FDA for new drug approval (NDA) to market the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, which are conducted after a drug or device has been approved by FDA for consumer sale.Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study.(Suvarna, V. 2010).Since drugs are approved on the basis of clinical trial involving relatively very small numbers of people who have been selected, they normally do not have other medical conditions which may exist in the general population. By conducting postmarketing surveillance company can further refine, or confirm or deny, the safety of a drug used by large numbers of people who have an extensive variety of medical conditions and taking multiple drugs.
Why is Phase IV increasingly important?
It is an Opportunity for a pharmaceutical companies at this stage: (1) company can compare
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