TÜRKÇE
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Information
| Unit | FACULTY OF PHARMACY |
| PHARMACY PR. | |
| Code | ECF406 |
| Name | Biopharmaceutical and pharmacokinetic |
| Term | 2020-2021 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 | Uzaktan Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ESRA DEMİRTÜRK |
| Course Instructor |
Dr. Öğr. Üyesi ESRA DEMİRTÜRK
(Bahar)
(A Group)
(Ins. in Charge)
|
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
Resources
Notes
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 | - | Have sufficient knowledge in pharmaceutical field and develop the knowledge gained. | 4 |
| PLO02 | - | Applies the profession in accordance with the existing laws and regulations,gains awareness of professional and ethical responsibility. | 4 |
| PLO03 | - | It serves the society as a pharmacist who is loyal to Atatürk's principles and reforms, equipped with Universal Knowledge, who uses Turkish correctly and knows at least one foreign language. | 4 |
| PLO04 | - | Communicates effectively both orally and in writing. | 4 |
| PLO05 | - | External appearance, attitude, attitude and behavior, with professional identity, role model and society becomes an example to colleagues. | 5 |
| PLO06 | - | Provides consultancy services to patients, community and health care personnel with a wide range of information on the drug,evaluates advanced knowledge and skills with a critical approach. | 5 |
| PLO07 | - | 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. | 4 |
| PLO08 | - | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | 4 |
| PLO09 | - | Interprets information about current health and treatment problems. Plays an active role in community health. | 4 |
| PLO10 | - | Pharmacy integrates and develops professional knowledge with information from different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | 4 |
| PLO11 | - | Students will be able to use the concepts and applications of basic sciences and basic medical sciences effectively in the field of Medicine and pharmacy and have the experience of working with these health sciences. | 4 |
| PLO12 | - | Acquires basic information about diseases, adopts and applies rational drug use on all drugs that affect systems. | 4 |
| PLO13 | - | By learning the basics of Clinical Pharmacy,will have the knowledge and skills to help provide drug/patient oriented pharmacy applications and individualized Pharmaceutical Care. | 4 |
| PLO14 | - | It plays a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. | 5 |
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 | Observation-Research | |
| 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 | 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 | Observation-Research | |
| 17 | Term Exams | Observation-Research |
Assessment (Exam) Methods and Criteria
| Assessment Type | Midterm / Year Impact | End of Term / End of Year Impact |
|---|---|---|
| 1. Midterm Exam | 100 | 40 |
| General Assessment | ||
| Midterm / Year Total | 100 | 40 |
| 1. Final Exam | - | 60 |
| Grand Total | - | 100 |
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 | ||