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Clinical Development

Health Care Term

Series of consequential studies regulated by the regulatory health authorities involving the trials of experimental drugs on humans with the aim of their possible introduction to the market. Clinical trials are typically conducted in three sequential phases, but the phases may overlap or be combined.

Phase I usually involves the initial introduction of the investigational drug into people to evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics and pharmacologic actions, and, if possible, to gain an early indication of its effectiveness.

Phase II usually involves trials in a limited patient population to (I) evaluate dosage tolerance and appropriate dosage, (II) identify possible adverse effects and safety risks, and (III) evaluate preliminarily the efficacy of the drug for specific indications.

Phase III trials usually further evaluate clinical efficacy and test further for safety by using the drug in its final form in an expanded patient population.

   
     
Related Health Care Terms
                     
                     
 Adenocarcinoma   Analogues   Arrhythmia  
 Adenosine   ANDA Abbreviated New Drug Application   Arteriosclerosis  
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