Early Trials on New Drugs
This chapter considers the ways in which early trials of new drugs differ from trials of established treatments. Greenwood and Todd  have defined three phases of early trials: trials to determine safety and early clinical pharmacology (phase I); trials to determine clinical efficacy and further clinical pharmacology (phase II); and trials for the early clinical development of the drug (phase III). A regulatory authority may be involved in these early trials and provide the approval necessary for the general release or marketing of a drug.
KeywordsRegulatory Authority Early Trial Large Randomise Control Trial General Release Tienilic Acid
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