semmelweis university 2 0 1 2 / 2 0 1 3

Basic concepts and importance of the Biopharmaceutical Classification System.
Biopharmaceutical considerations of drug distribution and metabolism.
Bioanalytical methods.
Excretion and clearance of drug. The biological half-life.
Bioavailability and influencing factors.
Studies and regulations on bioequivalence.
Importance of food-drug interactions.
Compartmental and non-compartmental modeling.
Physiologically based pharmacokinetic models.
Pharmacokinetics of multiple dosing.
In vitro – in vivo correlation and relationship.
Pharmacokinetic and metabolism investigations during preclinical and clinical development.
Practice
Study on the distribution of salicylic acid in a three-phase system.
In vitro test for drug liberation from a patch system.
In vitro drug release from oinments with local effect.
In vitro dissolution profile of conventional and modified release nitrofurantoin containing
preparations.
Determination of diclofenac sodium in synovial fluid samples.
Urinary excretion kinetics of aspirin.
Determination of theophylline plasma levels in beagle dogs after iv. administration.
Determination of theophylline plasma levels in beagle dogs after po. administration.
Calculation of bioavailability.
Computer modeling and analysis in pharmacokinetics.
Analyzing data to establish in vitro-in vivo correlation.
PHARMACEUTICAL ETHICS
Credit: 2
Lecturer: Prof. Dr. József Kovács
Syllabus (14 hours)
SEMMELWEIS UNIVERSITY / FACULTY OF PHARMACY
Course objectives:
a. To enable students to recognize ethical issues when encountered in everyday practice and
research
b. To provide students with a conceptual-logical system, which helps them to address ethical
questions and to resolve ethical dilemmas in an efficient way
c. To introduce students to a body of knowledge, which helps them to understand, respect and
protect the rights of patients, research subjects and fellow health care professionals
d. To help the would be health care professional to understand the responsibility of the
individual, of the health care system and of the society as a whole in maintaining health
Faculty of
Pharmacy
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