At the end of this course, the students; 1) Have knowledge about the basic concepts of dissolution rate and dissolution rate kinetics and the importance of dissolution in drug development and comparison of dissolution profiles. 2) Learn the basic concepts in pharmacokinetics and biopharmaceuticals, definitions and information related to reference drug and equivalent drug, bioavailability, bioequivalence. 3) Learn basic information about the design, evaluation and calculation of pharmacokinetic parameters of bioavailability / bioequivalence studies. 4) Learn the information about Biopharmaceutical Classification System (BCS) and biowaiver with examples. 5) Learn the concepts and information about pharmacokinetic modeling. 6) Have information about legal regulations about bioavailability and bioavailability (TITCK, EMA, FDA, WHO). 7) Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual. 8) Provides information and counseling to other healthcare 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
ECZ428 covers the basic concepts in biopharmaceutical, definition of bioavailability and bioequivalence, the basic concepts in pharmacokinetic, linear and nonlinear pharmacokinetic, legal regulations about bioavailability and bioequivalence.
COURSE CONTENTS
WEEK
TOPICS
1st Week
Basic concepts in biopharmaceutical, bioavailability and bioequivalence definitions
2nd Week
Dissolution, solubility, factors affecting solubility and dissolution rate, dissolution rate determination methods and Pharmacopoeia methods
3rd Week
Comparison of dissolution rate results, model independent methods, model dependent methods
4th Week
Assesment of in vitro- in vivo (IVIV)corelation
5th Week
Basic concepts in pharmacokinetics, linear and nonlinear pharmacokinetics
6th Week
Pharmacokinetic modeling; single compartment model (ıv and ıv infusion), absorption administration, multiple dosing
7th Week
MID TERM EXAMINATION
8th Week
Two compartment model: Basic concepts, I.V. injection, I.V. infusion and absorption administration
9th Week
Design of bioavailability and bioequivalence studies,
Factors affecting bioavailability and bioequivalence,
12th Week
Bioequivalence assessments in different dosage forms (such as imediately release, controlled release and fixed dose combinations)
13th Week
Bioavailability / bioequivalence assessments in nonlinear drugs and highly variable drugs
14th Week
Regulations of bioavailability / bioequivalence, biowaiver and biosimilarity, BCS (biopharmaceutics classification system) and BDDCS (biopharmaceutics drug disposition classification system)
RECOMENDED OR REQUIRED READING
1. Lecture 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.,) 3. Modern Pharmaceutics, Ed: Banker GS, Marcel Dakker Inc. New York, 2008.. 4. J.G.Wagner, Fundamentals of Pharmacokinetics, Hamilton Press, Inc., Hamilton, Illinois 62341. 4. Guidelines of Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy, 5. Guidelines of European Medicines Agency (EMA), 6. Guidelines of US Food and Drug Administration (FDA)
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
Lecture,Discussion
ASSESSMENT METHODS AND CRITERIA
Quantity
Percentage(%)
Mid-term
1
40
Total(%)
40
Contribution of In-term Studies to Overall Grade(%)
40
Contribution of Final Examination to Overall Grade(%)
60
Total(%)
100
ECTS WORKLOAD
Activities
Number
Hours
Workload
Midterm exam
1
2
2
Preparation for Quiz
0
0
0
Individual or group work
14
2
28
Preparation for Final exam
1
12
12
Course hours
14
2
28
Preparation for Midterm exam
1
12
12
Laboratory (including preparation)
0
0
0
Final exam
1
3
3
Homework
1
6
6
Total Workload
91
Total Workload / 30
3,03
ECTS Credits of the Course
3
LANGUAGE OF INSTRUCTION
Turkish
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)
