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How does research work?

 

Research into skin conditions goes on worldwide every day. Research follows prescribed conditions to ensure results are valid and trustworthy.

 

 

 

Phases I and II Trials

Phase 1 studies assess the safety of a drug or device

 

This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100)

 

The study looks at the effects of the drug including how it absorbed, metabolized, and excreted

 

It also investigates the side effects that occur as dosage levels are increased

 

About 70% of experimental drugs pass this phase of testing.

 

 

 

 

 

 

 

 

 

 

Phase II studies test the efficacy of a drug or device

 

This second phase of testing can last from several months to two years

 

It can involve up to several hundred patients who have the relevant condition

 

Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo

 

The studies may also be "blinded" which means that neither the patients nor the researchers know who has received the experimental drug

 

About one-third of experimental drugs successfully complete both Phase I and Phase II studies.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Phase III and IV Trials

 

 

Phase III studies involve randomized and blind testing in several hundred to several thousand patients

 

This large-scale testing, which can last several years, provides the pharmaceutical company with a more thorough understanding of the effectiveness of the drug or device, 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 complete, a pharmaceutical company can request approval for marketing the drug

 

 

 

 

 

 

 

 

 

 

 

 

Phase IV studies are conducted after a drug or device has been approved for consumer sale

 

Pharmaceutical companies have several objectives at this stage:

 

(1) to compare a drug with other drugs already in the market;

(2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and

(3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies

 

Phase IV studies are not used for all drugs or devices

 

 

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