GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION

BIOAVAILABILITY AND BIOEQUIVALENCE/FTE-3080

Course Title:	BIOAVAILABILITY AND BIOEQUIVALENCE
Credits	3	ECTS	8
Semester	1	Compulsory/Elective	Compulsory

COURSE INFO

-- LANGUAGE OF INSTRUCTION

Turkish

-- NAME OF LECTURER(S)

Assoc.Prof.Zeynep Şafak TEKSİN, Assoc.Prof.Tuba İnceçayır

-- WEB SITE(S) OF LECTURER(S)

http://www.websitem.gazi.edu.tr/site/zsteksin, http://www.websitem.gazi.edu.tr/site/tincecayir

-- EMAIL(S) OF LECTURER(S)

zsteksin@gazi.edu.tr, tincecayir@gazi.edu.tr

-- LEARNING OUTCOMES OF THE COURSE UNIT

Basic concepts on bioavailability and learning information through discussion, comparison of bioavailabiliy
Basic concepts on bioequivalence and learning information through discussion, comparison of bioequivalence
Learning biowaiver assessment

-- MODE OF DELIVERY

The mode of delivery of this course is face to face

-- PREREQUISITES AND CO-REQUISITES

There is no prerequisite or co-requisite for this course.

-- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS

There is no recommended optional programme component for this course.

--COURSE CONTENT
1. Week	Basic concepts and definations (generic name, chemical name, brand name, reference product and generic product)
2. Week	Bioavailability and bioequivalence concepts
3. Week	Bioavailabity criteria
4. Week	Calculation of area under the curve (AUC), application integral and trapezoidal rule
5. Week	Defination, calculation and comparison of AUCinf, Cmax and tmax parameters
6. Week	Design and assessment of bioavailability and bioequivalence studies
7. Week	Analytical method validation in bioavailabiliy and bioequivalence studies
8. Week	Factors affecting bioavailability and bioequivalence
9. Week	Types of bioequivalence studies (single dose, multiple dose, fasted state, fed state, and steady state studies)
10. Week	Bioavailability and bioequivalence studies for narrow therapeutic index and highly variable drugs
11. Week	Assesment of bioequivalence of variable dosage forms (immediate release, controlled release and fixed dose combinations)
12. Week	Waivig bioequivalence studies-Biowaiver criteria
13. Week	Biopharmaceutics Classification Systems (BCS) and Biopharmaceutics Drug Disposition Classification Systems (BDDCS)
14. Week	Regulations related to bioavailability, bioequivalence and biowaiver
15. Week
16. Week

-- RECOMMENDED OR REQUIRED READING

L.Shargel Applied Biopharmaceutics & Pharmacokinetics, The McGraw-Hill Companies, M.Burton, Applied Pharmacokinetics & Pharmacodynamics, Lippincott Williams & Wilkings

-- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS

Lecture, Question & Answer, Demonstration, Drill - Practise

-- WORK PLACEMENT(S)

-- ASSESSMENT METHODS AND CRITERIA

	Quantity	Percentage
Mid-terms	1	30
Assignment	1	10
Exercises	0	0
Projects	1	10
Practice	0	0
Quiz	0	0
Contribution of In-term Studies to Overall Grade		50
Contribution of Final Examination to Overall Grade		50

-- WORKLOAD

Efficiency	Total Week Count	Weekly Duration (in hour)	Total Workload in Semester
Theoretical Study Hours of Course Per Week	14	3	42
Practising Hours of Course Per Week	0	0	0
Reading	14	2	28
Searching in Internet and Library	9	3	27
Designing and Applying Materials	0	0	0
Preparing Reports	8	4	32
Preparing Presentation	5	7	35
Presentation	4	3	12
Mid-Term and Studying for Mid-Term	5	2	10
Final and Studying for Final	7	2	14
Other	0	0	0
TOTAL WORKLOAD:			200
TOTAL WORKLOAD / 25:			8
ECTS:			8

-- COURSE'S CONTRIBUTION TO PROGRAM

NO	PROGRAM LEARNING OUTCOMES	1	2	3	4	5
1						X
2						X
3						X
4						X
5			X
6						X
7					X
8						X
9			X
10						X

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GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR