Description of Individual Course Units
Course Unit CodeCourse Unit TitleType of Course UnitYear of StudySemesterNumber of ECTS Credits
300004752017BIOPHARMACEUTICS AND PHARMACOKINETICSCompulsory472
Level of Course Unit
First Cycle and Second Cycle
Language of Instruction
Turkish
Objectives of the Course
To provide to learn the difference between the in vitro data collected in the laboratory and the in vivo performance of the pharmaceutical formulation and bioavailability of drugs.
Name of Lecturer(s)
Prof. Dr. Ercüment Karasulu, Doç. Dr. Emel Öykü Çetin Uyanıkgil
Learning Outcomes
1learning definitions of bioavailability and bioequivalance
2To be informed of methods of determination of bioavailability, the test criteria of bioavailability, factors that effect bioavailability, bioequivalance, generics
3Getting information about: pharmacokinetics: compartment models, graphic models, linear regression, peeling method, calculation of area under the curve, calculation of pharmacokinetic parameters, application of intravenous infusion, loading dose,continuation dose
Mode of Delivery
Face to Face
Prerequisites and co-requisities
None
Recommended Optional Programme Components
None
Course Contents
Bioavailability, bioequivalence, factors effecting bioavailability, pharmacokinetic parameters, dose calculations, intravenous infusion, loading dose
Weekly Detailed Course Contents
WeekTheoreticalPracticeLaboratory
1Definition of biopharmacy, biopharmaceutic- pharmacokinetic- pharmacodynamic phases
2Definition of bioavailability, determination methods, parameters of bioavailability
3Absolute and relative bioavailability, example solution, definitions of pharmacological equivalance, pharmaceutical equivalance, chemical equivalance, pharmaceutical alternative, generics, original drug, patent
4Definitions of therapeutical equivalence, therapeutic alternative, bioequivalence and example solution
5The necessary and unnecessary conditions for bioavailability and bioequivalence studies
6The factors effect bioavailability
7Preparation of the protocol of bioavailability study
8Basic terms at pharmacokinetics: Absorption, distribution, elimination and metabolism
9Basic terms at pharmacokinetics: compartment term and mathematical models
10Intravenous drug application and evaluation of pharmacokinetics
11Oral drug application and evaluation of pharmacokinetics, pKa and the role of pKa at oral drug application
12Therapeutic drug monitoring: Application of single dose bolus, Tek doz bolus uygulama, application of more dose bolus and the strategy of arrangement of treatment window
13Therapeutic drug monitoring: The strategy of arrangement of treatment window, application of slow infusion, application of fast infusion
14Midterm
15Therapeutic drug monitoring: The strategy of arrangement of treatment window, combination of application single dose bolus+ infusion, fast slow infusion+ slow infusion
16Final exam
Recommended or Required Reading
Biyofarmasi ve farmakokinetik, Prof.dr. Aycıl KAYALI, Prof. Dr. Işık Tuğlular, 1992
Planned Learning Activities and Teaching Methods
Assessment Methods and Criteria
Term (or Year) Learning ActivitiesQuantityWeight
Midterm Examination1100
SUM100
End Of Term (or Year) Learning ActivitiesQuantityWeight
Final Sınavı1100
SUM100
Term (or Year) Learning Activities40
End Of Term (or Year) Learning Activities60
SUM100
Work Placement(s)
None
Workload Calculation
ActivitiesNumberTime (hours)Total Work Load (hours)
Midterm Examination133
Final Examination133
Practice6318
Tutorial6212
Individual Study for Homework Problems11212
Individual Study for Mid term Examination155
Individual Study for Final Examination155
TOTAL WORKLOAD (hours)58
Contribution of Learning Outcomes to Programme Outcomes
PO
1
PO
2
PO
3
PO
4
PO
5
PO
6
PO
7
PO
8
PO
9
PO
10
PO
11
PO
12
PO
13
PO
14
PO
15
PO
16
PO
17
PO
18
PO
19
PO
20
PO
21
LO1 4       3  44444   3
LO2 4       3  44444    
LO3         33 44 44    
* Contribution Level : 1 Very low 2 Low 3 Medium 4 High 5 Very High
 
Ege University, Bornova - İzmir / TURKEY • Phone: +90 232 311 10 10 • e-mail: intrec@mail.ege.edu.tr