Human subjects, drug evaluation

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

A drug candidate that completes pre-cUnical testing and maintains promise is then considered for evaluation in human subjects. The first step in this process is the... 

The NME can now be administered to humans. The first step in clinical evaluation is one or more phase I studies designed to assess the drug s safety and pharmacokinetic profile. Phase I studies usually involve a small number of healthy volunteers who are closely monitored after receiving escalating doses of the drug candidate. Phase I studies of drugs for cancer or HIV infection must be carried out in patients, not in healthy subjects. Ordinarily, until more information is available, the minimum dose to induce side effects is stipulated as the upper dose limit for subsequent administration to human subjects. 

Clinical trials are planned experiments involving human subjects, designed to answer a clinically relevant question concerning treatment. Many involve the evaluation of drugs. In a clinical trial one uses resu ts from a limited sample of subjects to make inferences about the general population. Drug trials are by convention classified into four phases ... 

The lead optimization process introduces structural variations in the molecule in order to identify the best drug candidate. After a thorough evaluation of its toxicity and pharmacological activity in animal models, the molecule enters the clinical phases, when it is evaluated for tolerability, efficacy, and potential side effects on human subjects. After submittal of all the required documentation and registration to the appropriate authority (e.g. the U.S. Food and Drug Administration), the HIV protease inhibitor is ready for launching on the market. 

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