MF9450 – Introduction to bioequivalence and non-inferiority
Schedule, syllabus and examination date
The course will give an introduction to bioequivalence and non-inferiority trials, and the analysis of such. As more and more clinical trials are focused on showing equivalence rather than efficacy, this type of studies become more and more common and important. The analysis of such studies are fundamentally different from analysis of traditional efficacy studies, and other methods are required.
How do you set about showing significant sameness? This course will introduce the field to the student, paying as much attention to practical matters and philosophical issues as to the mathematics. Because cross-over trials have some complications of their own and because bioequivalence studies are most commonly designed as cross-over trials the course will also include a basic introduction to cross-over trials. Some very elementary pharmacokinetic theory will also be covered since an understanding is essential to understanding bioequivalence.
In the second half of the course, ACES (active comparator equivalent studies) will be considered. Once the basic theory has been covered, the issue of combining results from such studies with results from meta-analyses of the comparator to produce an interval for the difference to a ‘putative placebo’ will be considered.
Ph.D. candidates and students at the Medical Student Research Programme will get first priority to the course. The maximum number of participant is 20.
Formal prerequisite knowledge
Recommended previous knowledge
Some knowledge of clinical trials.
The course will be a mix of lectures, practical exercises and discussions in groups.
Students need to take their own laptop to classes. We will provide electricity. Data and other material will be made available before the course on this web page for downloading on your laptop.
NB! You have to participate in at least 80 % of the teaching to be allowed to take the exam. Attendance at lectures will be registered.
A take-home exam will be given at the end of the course. Grading: Pass/fail.
Explanations and appeals
The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.