Erciyes University - Info Package

Course unit title	Level of course unit	Course unit code	Type of course unit	Semester of course unit	Local credit	ECTS credit	Syllabus
BIOAVAILABILITY AND BIOEQUIVALENCE	Third cycle	ECF 616		1	6.00	6.00	Print

Description of course unit

Prerequisites and course requisities	-
Language of instruction	Turkish
Coordinator	Assist. Prof. Dr. Eren Demirpolat
Lecturer(s)	Assist. Prof. Dr. Eren Demirpolat
Teaching assitant(s)	-
Mode of delivery	Presentation, question answer method and studying on regarding documents
Course objective	To teach general principles of bioavailability studies, understanding the importance of a pharmacist in this type of study, get to know regarding documents
Course description	In this study students are expected to learn general principles and designing of bioavaility and bioequivalance studies.

Course contents

1	Definition of bioavailability, bioequivalance studies and absorption
2	Oral bioavailability analysis, basic pharmacokinetic parameters
3	Introduction to bioequivalance study
4	Clinical and analytical phases of a bioequivalance study-1
5	Clinical and analytical phases of a bioequivalance study-2
6	Documents used in bioequivalance studies-1
7	Documents used in bioequivalance studies-2
8	Documents used in bioequivalance studies-3
9	Documents used in bioequivalance studies-4
10	The role of a pharmacist in bioequivalance studies
11	Real life examples of bioequivalance studies-1
12	Real life examples of bioequivalance studies-2
13	Real life examples of final study report
14	Introduction to biosimilarity studies
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Learning outcomes of the course unit

1	Learning absorption and other pharmacokinetic parameters
2	Learning basic principles of bioavailability and bioequivalance studies
3	Learning how to design bioavailability studies
4	Identifying regarding documents
5	Learning ethical considerations of bioavalibility and bioequivalance stuides
6	Understanding the role of a pharmacist in these studies
7	Learning basic principles of biosimilarity studies
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*Contribution level of the course unit to the key learning outcomes

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Number of stars refer to level of contribution from 1 (the least) to 5 (the most)

Planned learning activities, teaching methods and ECTS work load

	Quantity	Time (hour)	Quantity*Time (hour)
Lectures (face to face teaching)	14	2	28
Study hours out of classroom (study before and after the class)	14	5	70
Homework	0	0	0
Presentation / seminar	0	0	0
Quiz	0	0	0
Preparation for midterm exams	1	20	20
Midterm exams	1	2	2
Project (term paper)	0	0	0
Laboratuar	0	0	0
Field study	0	0	0
Preparation for final exam	1	20	20
Final exam	1	2	2
Research	1	10	10
Total work load			152
ECTS			6.00

Assessment methods and criteria

Evaluation during semester	Quantity	Percentage
Midterm exam	1	40
Quiz	0	0
Homework	0	0
Semester total		40
Contribution ratio of evaluation during semester to success		40
Contribution ratio of final exam to success		40
General total		80

Recommended and required reading

Textbook	Oğuz Kayaalp Klinik Farmakolojinin Esasları ve Temel Düzenlemeler
Additional references	Scientific web sources about bioequivalence trials and guidelines of EMA

Files related to the course unit