ECF406 Biopharmaceutical and pharmacokinetic

2 ECTS - 2-0 Duration (T+A)- 8. Semester- 2 National Credit

Information

Code ECF406
Name Biopharmaceutical and pharmacokinetic
Term 2022-2023 Academic Year
Semester 8. Semester
Duration (T+A) 2-0 (T-A) (17 Week)
ECTS 2 ECTS
National Credit 2 National Credit
Teaching Language Türkçe
Level Lisans Dersi
Type Normal
Mode of study Yüz Yüze Öğretim
Catalog Information Coordinator Dr. Öğr. Üyesi ESRA DEMİRTÜRK
Course Instructor Dr. Öğr. Üyesi ESRA DEMİRTÜRK (A Group) (Ins. in Charge)


Course Goal / Objective

The aim of this course is to teach the bioavailability and bioequivalence studies, study designs and bioequivalence and bioequivalence parameters and to evaluate the results.

Course Content

Bioavailability, bioequivalence, bioavailability and bioequivalence affecting physiological and pharmaceutical factors, calculation of bioavailability and bioequivalence parameters, in vitro-in vivo correlations, compartment models and their importance.

Course Precondition

None

Resources

1. Malcolm Rowland, Thomas N. Tozer. Clinical Pharmacokinetics, Concepts and Applications, Third Edition, Williams and Wilkins, Baltimore 1995. 2. Leon Shargel, Adrew B. C. Yu. Applied Biopharmaceutics and Pharmacokinetics, Third Edition, Pentice-Hall International Editions, 1993.

Notes

1. Malcolm Rowland, Thomas N. Tozer. Clinical Pharmacokinetics, Concepts and Applications, Third Edition, Williams and Wilkins, Baltimore 1995. 2. Leon Shargel, Adrew B. C. Yu. Applied Biopharmaceutics and Pharmacokinetics, Third Edition, Pentice-Hall International Editions, 1993.


Course Learning Outcomes

Order Course Learning Outcomes
LO01 Design bioavailability and bioequivalence studies.
LO02 Know the basic concepts of bioavailability and bioequivalence studies and study designs
LO03 Calculates the parameters of bioavailability and bioequivalence, evaluates the results,
LO04 Calculates pharmacokinetic parameters from the urine and plasma data as a function of the route of administration.
LO05 Define physiological and pharmaceutical factors affecting bioavailability and bioequivalence.
LO06 Defines the importance of compartment models.
LO07 Makes the study design of bioavailability and bioequivalence appropriate to the route of administration of the drug.


Relation with Program Learning Outcome

Order Type Program Learning Outcomes Level
PLO01 Bilgi - Kuramsal, Olgusal Have sufficient knowledge in pharmaceutical field and develop the knowledge. 4
PLO02 Bilgi - Kuramsal, Olgusal Comprehends professional knowledge with ethical responsibility through current laws and legislation.
PLO03 Beceriler - Bilişsel, Uygulamalı Provides consultancy service to patients, community and health care personnel and evaluates advanced knowledge and skills with a critical approach. 3
PLO04 Beceriler - Bilişsel, Uygulamalı Possessing the knowledge of historical and current developments in the field of Pharmacy, monitoring, evaluation and application of scientific and evidence-based data, and adopting lifelong learning. 2
PLO05 Beceriler - Bilişsel, Uygulamalı Have the knowledge and skills to help provide patient-oriented pharmacy applications and individualized pharmaceutical care by learning the basics of Clinical Pharmacy, 2
PLO06 Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği Takes a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. 2
PLO07 Yetkinlikler - Öğrenme Yetkinliği Integrates and develops professional knowledge via different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community.
PLO08 Yetkinlikler - Öğrenme Yetkinliği Use effectively the concepts and applications of basic sciences and basic medical sciences in the field of medicine and pharmacy and update the information.
PLO09 Yetkinlikler - İletişim ve Sosyal Yetkinlik Communicates effectively in writing and speaking.
PLO10 Yetkinlikler - İletişim ve Sosyal Yetkinlik Practices the profession in accordance with Atatürk's principles and reforms, equipped with universal knowledge, uses Turkish correctly and knows at least one foreign language.
PLO11 Yetkinlikler - İletişim ve Sosyal Yetkinlik Be an example to society withexternal appearance, demeanor, attitude and behavior for the other professionals and society and with professional identity 2
PLO12 Yetkinlikler - Alana Özgü Yetkinlik Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. 1
PLO13 Yetkinlikler - Alana Özgü Yetkinlik Interprets information about current health and treatment problems and attends meeting on related matters . Plays an active role in community health.
PLO14 Yetkinlikler - Alana Özgü Yetkinlik Acquires basic information about diseases, makes decisions about the drugs used in treatment in accordance with rational drug use.


Week Plan

Week Topic Preparation Methods
1 Drug absorption mechanisms, bioavailability and bioequivalence general definitions Observation-Research Öğretim Yöntemleri:
Anlatım, Soru-Cevap
2 Pharmaceutical factors affecting bioavailability and bioequivalence Observation-Research Öğretim Yöntemleri:
Anlatım, Soru-Cevap
3 Bioavailability and bioequivalence study design Observation-Research Öğretim Yöntemleri:
Anlatım, Soru-Cevap
4 Statistical criteria in bioavailability and bioequivalence studies Observation-Research Öğretim Yöntemleri:
Anlatım, Tartışma
5 Calculation of bioavailability and bioequivalence criteria Observation-Research Öğretim Yöntemleri:
Anlatım, Beyin Fırtınası
6 Biopharmaceutical classification system Observation-Research Öğretim Yöntemleri:
Anlatım
7 Definitions, compartment models and their importance Observation-Research Öğretim Yöntemleri:
Anlatım
8 Mid-Term Exam topic repetition Ölçme Yöntemleri:
Yazılı Sınav
9 Single compartment model - i.v.injection Observation-Research Öğretim Yöntemleri:
Anlatım
10 i.v. Injection-sample problem solutions Observation-Research Öğretim Yöntemleri:
Anlatım, Soru-Cevap, Tartışma
11 Single compartment model - i.v.infusion Observation-Research Öğretim Yöntemleri:
Anlatım
12 Single compartment model - i.v.infusion 2 Observation-Research Öğretim Yöntemleri:
Anlatım
13 Single compartment model-Extravascular application Observation-Research Öğretim Yöntemleri:
Anlatım
14 Model-independent pharmacokinetic Observation-Research Öğretim Yöntemleri:
Anlatım
15 Double Compartment model Observation-Research Öğretim Yöntemleri:
Anlatım, Soru-Cevap
16 Term Exams topic repetition Ölçme Yöntemleri:
Yazılı Sınav
17 Term Exams topic repetition Ölçme Yöntemleri:
Yazılı Sınav


Student Workload - ECTS

Works Number Time (Hour) Workload (Hour)
Course Related Works
Class Time (Exam weeks are excluded) 14 2 28
Out of Class Study (Preliminary Work, Practice) 14 1 14
Assesment Related Works
Homeworks, Projects, Others 0 0 0
Mid-term Exams (Written, Oral, etc.) 1 4 4
Final Exam 1 8 8
Total Workload (Hour) 54
Total Workload / 25 (h) 2,16
ECTS 2 ECTS

Update Time: 25.11.2022 01:47