Once a phase III study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug.

Post-Marketing -- Late Phase Three/Phase Four Studies In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Funding for clinical research comes from both the federal government (through the National Institutes of Health) and private industry (pharmaceutical and biotech companies).

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The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted.

A phase I study will investigate side effects that occur as dosage levels are increased.

A Phase One Study: Phase I studies are primarily concerned with assessing the drug's safety.

This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study.

If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in humans.

This is called an Investigational New Drug application (IND).Only about one-third of experimental drugs successfully complete both phase I and phase II studies.A Phase Three Study: In a phase III study, a drug is tested in several hundred to several thousand patients.Just give them dicks and they will take care of them faster than you can imagine!Introduction Before a pharmaceutical company can initiate testing in humans, it must conduct extensive preclinical or laboratory research.A Phase Two Study: Once a drug has been shown to be safe, it must be tested for efficacy.