This course is created to introduce the issue of a bioequivalence of medicinal products to the new employee of the Regulatory Affairs Department. Course is dedicated to junior specialists or specialists that start their work in pharmaceutical company and have none or very limited experience in area of registration processes of the medicinal products
Student will learn what is the purpose of a medicinal product bioequivalence study, what important definitions are connected with these studies and when these studies are required for registration application. During the course Student will get information about the pharmaceutical equivalence, therapeutic equivalence and Bioavailability
In the course it will be explained what are the bioequivalence testing methods available, which one of them is preferable and what parameters are determining the results of the study. Concept of Area Under Curve , the maximum concentration of the drug in the serum , time of occurrence of Cmax and Plasma concentration half-life will be presented
It will be also explained what information and circumstances need to be assessed and considered before starting the bioequivalence trial. Student will see how many details need to be established before the bioequivalence study can start. In addition it will be mentioned in the course what is the guiding document of clinical research project that includes all relevant information on the test methods used and the objectives of the study
Student will learn what kinds of study designs are available and how the general bioequivalence study plan looks like. During the course Student will get elementary information about the Crossover design, Parallel design, Replicate designs of the study
As Regulatory Affairs Department members we have impact on the quality of submitted files and our knowledge can support effective and undisturbed regulatory process. All information presented in this course will help a new employee to be better prepared to work with registration dossier and step into discussion with Authority or other experts if needed
