TÜRKÇE
ENGLISH
Information
| Code | ECF406 |
| Name | Biopharmaceutical and pharmacokinetic |
| Term | 2024-2025 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 |
| Label | C Compulsory |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ESRA DEMİRTÜRK |
| Course Instructor |
1 2 |
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 | |
| 2 | Pharmaceutical factors affecting bioavailability and bioequivalence | Observation-Research | |
| 3 | Bioavailability and bioequivalence study design | Observation-Research | |
| 4 | Statistical criteria in bioavailability and bioequivalence studies | Observation-Research | |
| 5 | Calculation of bioavailability and bioequivalence criteria | Observation-Research | |
| 6 | Biopharmaceutical classification system | Observation-Research | |
| 7 | Definitions, compartment models and their importance | Observation-Research | |
| 8 | Mid-Term Exam | topic repetition | |
| 9 | Single compartment model - i.v.injection | Observation-Research | |
| 10 | i.v. Injection-sample problem solutions | Observation-Research | |
| 11 | Single compartment model - i.v.infusion | Observation-Research | |
| 12 | Single compartment model - i.v.infusion 2 | Observation-Research | |
| 13 | Single compartment model-Extravascular application | Observation-Research | |
| 14 | Model-independent pharmacokinetic | Observation-Research | |
| 15 | Double Compartment model | Observation-Research | |
| 16 | Term Exams | topic repetition | |
| 17 | Term Exams | topic repetition |
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 | ||