Pharmaceutical Statistics Using SAS

1.3. Statistical support to clinical testing

Clinical testing is typically conducted in a staged fashion to explore the effect of pharmaceutical products on humans. The investigation starts with pharmacokinetic and pharmacodynamic studies, followed by proof-of-concept and dose-ranging studies. Some specialty studies such as drug effect on QT/QTc prolongation and drug-drug interactions studies are conducted at this early stage. The identification of Common adverse reactions and early signs of efficacy are the objectives of such trials. The early testings, if satisfactory, lead to the confirmatory phase where the efficacy and safety of the product candidate are more thoroughly investigated in a more heterogeneous population.

Despite common statistical ...