APPLIED BIOPHARMACEUTICS
Course objectives:
The main goal of biopharmacy is to provide pharmacy students with design and evaluation of bioequivalence studies, technological, physiological, patophysiological factors related to drug pharmacokinetics and biopharmaceutical aspects of drug delivery systems. Pharmaceutical and biological availability of medicinal substances in different dosage forms as well as the influence of dosage form and route of administration on bioavailability of drugs will be of concern.
Course content:
This course involves lectures (12) and seminars (28).
I. Lectures:
1. Methods for assessing bioavailability
2. Biopharmaceutical aspects of transdermal drug delivery system
3. Vaginal and rectal drug delivery systems
4. TCI systems
5. Biopharmaceutical aspects of oral drug delivery
6. Biopharmaceutical aspects of topical ocular drug delivery
II. Seminaries
1. Technological factors determining drug bioavailability
2. Design and evaluation of bioequivalence studies
3. Biosimilars – aspects of safety, pharmacovigilance and substitution
4. Nasal drug delivery systems
5. Oral mucosal drug delivery systems
6. Biopharmaceutical aspects of intravenous administration
7. Bioequivalence Studies of Generic Products for Topical Use
8. Application of pharmacokinetics in clinical situation
9. Pulmonary drug delivery systems
10. Pharmacokinetic calculations. Bioavaliability.
11. PKPD relationship.
Credit of this program is based on attendance and test including 20-30 questions.
The seminaries are obligatory for the students. The students are allowed not to attend one seminar with no written excuse. One additional absence must be formally excused (within a two-week period after return to the University) and students will have to write a report on the related topic or pass an extra test covering teaching material of the missed seminar (to be decided by the responsible for the course). Attendance at lectures is not obligatory.
Reading Material:
1. After each seminar the presenting person will provide you the authorized handouts