Clinical trials and the regulation of drugs

Paul Leber Introduction

Whyandhowlhe United States, Federal Government., .came, to...exe.rcis,e ..control., over, thequality., ofthe drug.supply

Securing., .theaims, .ofreguiation

Principles., iof..iciliiniicali, .tria.l.„d,es.i„gn, ..c.on.d„u.c,t,„an.d.., interpretation Th£.„ch,oi£e.., of. . control. , conditions Assay., .sensitivity

Problems.of, bias

What, .is ..'substantial: evidence?

Approval., as,, a,..risk—benefit., determination

The.., future ..of., c.o.nt.roile,d...c,lini,cal .regulatory., trials C.h.apte.r.,Refe.rence.s

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