At the end of this course, the students; 1) Knows the importance of dissolution rate studies in drug development, bioavailability and bioequivalence and comparison of dissolution profiles. 2) Learns the definitions of reference drug and generic drug, bioavailability, bioequivalence. 3) Learns the basic information about the design and evaluation of bioavailability/bioequivalence studies, calculation of pharmacokinetic parameters. 4) Learns information about Biopharmaceutical Classification System (BCS) and biowaiver with examples. 5) Gains information about legal regulations (TITCK, EMA, FDA, WHO) related to bioavailability and bioequivalence, 6) Health personnel, society and institutions with the knowledge and skills gained.
MODE OF DELIVERY
Face to face
PRE-REQUISITES OF THE COURSE
No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT
None
COURSE DEFINITION
This course; Basic concepts in biopharmaceuticals, definitions of bioavailability and bioequivalence, the importance of dissolution rate studies in drug development, the importance of bioavailability and bioequivalence and the comparison of dissolution profiles, bioavailability / bioequivalence study designs, bioequivalence biowaiver criteria and legal regulations on bioavailability and bioequivalence (TİTCK, EMA, FDA, WHO) covers.
COURSE CONTENTS
WEEK
TOPICS
1st Week
Basic concepts, bioavailability and bioequivalence definitions in biopharmaceuticals
2nd Week
The importance of dissolution rate studies in drug development
3rd Week
Factors affecting the dissolution rate and methods for determining the dissolution rate
4th Week
The importance of dissolution studies in the development of oral solid drug forms, biowaiver
5th Week
Factors affecting the dissolution rate and methods for determining the dissolution rate
6th Week
Bioavailability and bioequivalence criteria, calculations, evaluations
7th Week
MIDTERM EXAMINATION
8th Week
Bioequivalence assessments in different dosage forms (such as immediate release, controlled release and fixed dose combinations, topical dosage forms)
9th Week
Bioequivalence assessments in different dosage forms (such as immediate release, controlled release and fixed dose combinations, topical dosage forms)
10th Week
Biopharmaceutical Classification System (BCS) and basic principles of biowaiver
11th Week
Biopharmaceutical Classification System (BCS) and basic principles of biowaiver
12th Week
Legal regulations on bioavailability and bioequivalence (TİTCK)
13th Week
Legal regulations on bioavailability and bioequivalence (EMA )
14th Week
Legal regulations on bioavailability and bioequivalence (FDA, WHO)
RECOMENDED OR REQUIRED READING
1. Lecturer notes 2. Modern Farmasötik Teknoloji, TEB Eczacılık Akademisi Yayını (Acartürk,F., Ağabeyoğlu,İ., Çelebi,N., Değim, T., Değim, Z.,Doğanay,T.,Takka,S., Tırnaksız,F.,),2009 3. J.G.Wagner, Fundamentals of Pharmacokinetics, Hamilton Press, Inc., Hamilton, Illinois 62341. 4. 5.Dissolution Bioavailability & Bioequivalence, Abdou, H.M. Marc Printing Company, 5. Guidlines, TİTCK, EMA, WHO ve FDA
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
Teorik, interaktif tartışma
ASSESSMENT METHODS AND CRITERIA
Quantity
Percentage(%)
Assignment
2
20
Practice
14
20
Other
2
10
Total(%)
50
Contribution of In-term Studies to Overall Grade(%)
50
Contribution of Final Examination to Overall Grade(%)
50
Total(%)
100
ECTS WORKLOAD
Activities
Number
Hours
Workload
Midterm exam
0
0
0
Preparation for Quiz
0
0
0
Individual or group work
14
2
28
Preparation for Final exam
1
14
14
Course hours
14
2
28
Preparation for Midterm exam
0
0
0
Laboratory (including preparation)
0
0
0
Final exam
1
3
3
Homework
2
12
24
Presentation (including preperation)
1
14
14
Literature review
12
3
36
Total Workload
147
Total Workload / 30
4,9
ECTS Credits of the Course
5
LANGUAGE OF INSTRUCTION
Turkish
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)