This course will introduce the practical and regulatory design elements and consideration of human clinical trials for the purposes of demonstrating bioequivalence between drug products. The principles discussed are currently used by generic and innovator drug companies in many countries. Students will learn about the regulations, methods, techniques, pharmacokinetics, and biostatistics involved in creating bioequivalence studies. The course has a heavy mathematical emphasis, with a large component dedicated to mathematical modeling (non-compartmental and compartmental pharmacokinetic modeling, and biostatistics). Also discussed are clinical trial sample size determination, bioequivalence study design elements, clinical study protocol and final report writing, disaster recovery and outlier analysis, and design of steady-state studies. A module is also included on developing and improving interview skills. After taking this course, students will understand the steps required to set up single-dose and steady-state pilot and pivotal bioequivalence trials using parallel, crossover, and semi-replicate designs, and be well-poised for entry-level scientific positions in industry.
This course will introduce the practical and regulatory design elements and consideration of human clinical trials for the purposes of demonstrating bioequivalence between drug products. The principles discussed are currently used by generic and innovator drug companies in many countries. Students will learn about the regulations, methods, techniques, pharmacokinetics, and biostatistics involved in creating bioequivalence studies. The course has a heavy mathematical emphasis, with a large component dedicated to mathematical modeling (non-compartmental and compartmental pharmacokinetic modeling, and biostatistics). Also discussed are clinical trial sample size determination, bioequivalence study design elements, clinical study protocol and final report writing, disaster recovery and outlier analysis, and design of steady-state studies. A module is also included on developing and improving interview skills. After taking this course, students will understand the steps required to set up single-dose and steady-state pilot and pivotal bioequivalence trials using parallel, crossover, and semi-replicate designs, and be well-poised for entry-level scientific positions in industry.
