PHARMACOEPIDEMIOLOGY as well,and ok.a discussed in Part III of this order to ev Finally,the 1980 anc the 1990s ea one of phase 3 studies needs to its exclusive emphasis o and sta reactions to the of othe cal trials usually needs to be c dem to ficial d in the the d applica on of health nom s to the study of 3,even if drug efficacy can be demo nstrated w in order to be abl tail in part Iv of this book ple,a study including 3000 tients would all one t ng any adve THE CURRENT DRUG APPROVAL the other one to be 95 The current drug approval process in the US occur in six or more nts out of ev preclinical testing h testing Phase ted in these narketing studies.The sam teers and aucte ntial trials or the etect drug effects are discuss of the drug e dosage range in hum and to exclude h on a small num ber o Ho Table 1.1) of them testing is usually the first time patients which the dru吗oic ns to this ar of appr be considered ethical to expose no e will fig to them toxic dru Fo studies uppleme marketing. well. of inf nacokinetics of can be obtai ned fro idemiolo eaction and to obtain not be e obtained prio le cacy of the drug. era and probably nost important and regimen to be tested more y usly studies can In ea rig in marketing studies will be briefly examined fir: 3 testing is tigators in a muchlarger clarify how postmarketing studies can add te