ISTINYE UNIVERSITY BİLGİ PAKETİ / DERS KATALOĞU
| Pharmacy (English) | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
Course Introduction and Application Information
| Course Code: | PHA518 | ||||
| Course Name: | Pharmaceutical Technology 4 | ||||
| Semester: | Fall | ||||
| Course Credits: |
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| Language of instruction: | English | ||||
| Course Condition: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Compulsory Courses | ||||
| Course Level: |
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| Mode of Delivery: | Face to face | ||||
| Course Coordinator: | Dr. Öğr. Üy. ABDULLAH LEVENT ALPARSLAN | ||||
| Course Lecturer(s): | Pharm. Dr. Abdullah Levent Alparslan, Pharm. Dr. Ece Özcan Bülbül | ||||
| Course Assistants: |
Course Objective and Content
| Course Objectives: | Course objective is to teach basic concepts of the biopharmaceutical and pharmacokinetic, drug bioavailability and bioequivalence affecting pharmaceutical production of dosage forms and evaluate formulation factors related to drug bioavailability and bioequivalence in terms of belonging to different dosage forms. Explain in vitro dissolution rate method regarding bioavailability studies and bioequivalence study design. The aim is to inform students about statistical criteria and legal regulations related to the subject. |
| Course Content: | Dissolution rate, in vitro dissolution rate tests, factors affecting the dissolution rate of drugs from pharmaceutical dosage forms, drug absorption mechanisms, basic concepts of bioavailability and bioequivalence, legal regulations and guidelines, calculation of pharmacokinetic parameters of parenteral and oral dosage forms, in vitro and in vitro in vivo correlation issues. |
Learning Outcomes
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The students who have succeeded in this course;
1) Students have knowledge about drug bioavailability and pharmacokinetics. 2) Student will understand the importance of the properties of the active substance, the dosage form and the route of drug administration. 3) Student will have an idea about the distribution, absorption, metabolism and excretion of the drug in the body. 4) Student comprehends the dissolution rate, in vitro dissolution rate tests, factors affecting the dissolution rate of drugs from pharmaceutical dosage forms. 5) Student defines basic concepts about drug absorption mechanisms. 6) Student gains knowledge of basic concepts, regulations and guidelines related to bioavailability and bioequivalence. 7) Student calculates pharmacokinetic parameters of parenteral and oral dosage forms. 8) Student defines the basic concepts of in vitro and in vivo correlation issues. |
Course Flow Plan
| Week | Subject | Related Preparation |
| 1) | Introduction to biopharmaceutical applications | |
| 2) | Absorption, distribution, metabolism and elimination of the drug | |
| 2) | Absorption, distribution, metabolism and elimination of the drug | |
| 3) | Effect of drug administration routes on absorption and bioavailability | |
| 4) | Factors affecting bioavailability, Absolute and Relative Bioavailability calculations | |
| 5) | Bioequivalence and types of equivalence in drugs | |
| 6) | Bioavailability and Bioequivalence clinical trial protocols. | |
| 7) | Biopharmaceutical classification system. Solubility and dissolution rate parameters | |
| 8) | Introduction to Pharmacokinetics, the pharmacokinetic parameters | |
| 9) | IV applications and examination of pharmacokinetic parameters | |
| 10) | Oral administration and examination of pharmacokinetic parameters | |
| 11) | Pharmacokinetic behavior of active substances in the body | |
| 12) | Compartment models, Pharmacokinetic modeling | |
| 13) | Clinical trial examples and evaluations | |
| 14) | Biological products and Biosimilars | |
| 15) | Final Exams |
Sources
| Course Notes / Textbooks: | 1. MODERN FARMASÖTİK TEKNOLOJİ, F. ACARTÜRK, İ. AĞABEYOĞLU, N. ÇELEBİ, T. DEĞİM, Z. DEĞİM, T. DOĞANAY, S. TAKKA, F. TIRNAKSIZ, 2006. 2. FARMASÖTİK TEKNOLOJİ-TEME KONULAR VE DOZAJ ŞEKİLLERİ, A.Z. GÜRSOY, 2004. 3. APPLİED BİOPHARMACEUTİCS & PHARMACOKİNETİCS, L.SHARGEL, S.WU-PONG, A.B.C. YU, 2005. 4. PYSİCAL PRİNCİPLES OF PHARMACY, A.T. FLORENCE, D. ATWOOD, 2006. 5. BASİC PHARMACOKİNETİC, M.A. HEDAYA, 2007. 6.MATHEMATICAL MODELING OF PHARMACOKINETIC DATA D.W.A BOURNE COLLEGE OF PHARMACY OKLAHAMA UNI. 1. MODERN PHARMACEUTICAL TECHNOLOGY, F. ACARTÜRK, İ. AĞABEYOĞLU, N. ÇELEBİ, T. DEĞİM, Z. DEĞİM, T. DOĞANAY, S. TAKKA, F. TIRNAKSIZ, 2006. 2. PHARMACEUTICAL TECHNOLOGY-KEY SUBJECTS AND DOSAGE FORMS, AZ GÜRSOY, 2004. 3. APPLIED BIOPHARMACEUTICS & PHARMACOKINETICS, L. SHARGEL, S. WU-PONG, ABC YU, 2005. 4. PYSICAL PRINCIPLES OF PHARMACY, AT FLORENCE, D. ATWOOD, 2006. 5. BASIC PHARMACOKINETIC, MA HEDAYA, 2007. 6.MATHEMATICAL MODELING OF PHARMACOKINETIC DATA DWA BOURNE COLLEGE OF PHARMACY OKLAHAMA UNI. |
| References: | YÖNETMELİKLER, ICH GUIDELINES REGULATIONS, ICH GUIDELINES |
Course - Program Learning Outcome Relationship
| Course Learning Outcomes | 1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
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| Program Outcomes | |||||||||||
| 1) Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | |||
| 2) Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | |||
| 3) Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
| 4) Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | |||
| 5) Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |||||||||||
| 6) Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |||||||||||
| 7) Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |||||||||||
| 8) He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
| 9) Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
| 10) As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
| 11) He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
Course - Learning Outcome Relationship
| No Effect | 1 Lowest | 2 Average | 3 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Applies and develops the universal and social dimensional effects of basic, professional and technological knowledge in the field of pharmacy as well as pharmacy practice interdisciplinary by following legal, deontological and ethical rules. | 3 |
| 2) | Defines the terminology related to the pharmacy profession; solves problems , accesses scientific information in the field of pharmacy, after monitoring and evaluating the current literature, applies , communicates, shares by using information technologies effectively and efficiently. | 2 |
| 3) | Uses theoretical and practical knowledge about the anatomical structure of the human body, the physiological working principles of systems, biochemical, immunological events in the organism and microorganisms. | |
| 4) | Uses basic and advanced analytical techniques and methods by running qualitative/quantitative analyzes and interprets the findings by using appropriate statistical methods. | 1 |
| 5) | Defines medicinal plants, herbal drugs and active substances; gains the skills for the development of natural products used for medical purposes. | |
| 6) | Applies patient-centered and individualized pharmaceutical care service together with other healthcare personnel within the framework of rational drug use by using the principles of clinical pharmacy, pharmacoeconomics, pharmacotherapy and phytotherapy. | |
| 7) | Knows the biological properties, structure-activity relationships, and metabolisms of drugs and gains the skill for the synthesize and development of new drug candidates. | |
| 8) | He/She is competent at formulations, production, stability, quality assurance, licensing, patent studies, legal regulations of products containing natural origin and / or synthetic active substances, advanced therapy medicinal products, radiopharmaceuticals and cosmetic products. | |
| 9) | Interprets the pharmacokinetic and pharmacodynamic properties of drugs, the factors that change their effect, their toxic effects, pharmacolygical activities and their risk assessment method. Reports the drug interactions and adverse drug reactions, monitors and applies the theoretical/practical knowledge for preventing them. | 3 |
| 10) | As a health professional in his/her profession he/she acts as a caregiver, decision maker, communicator, manager, lifelong learner, instructor, leader and researcher, he/she complies with the principles of evidence-based pharmacy by making teamwork for the benefit of society, national and universal values. | 3 |
| 11) | He/She works in various fields such as community pharmacy, hospitals, pharmaceutical medical devices, herbal products and cosmetics sectors, health institutions and agencies, clinical research organizations , universities and R&D centers. | 3 |
Assessment & Grading
| Semester Requirements | Number of Activities | Level of Contribution |
| Midterms | 1 | % 30 |
| Final | 1 | % 70 |
| total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 30 | |
| PERCENTAGE OF FINAL WORK | % 70 | |
| total | % 100 | |
Workload and ECTS Credit Calculation
| Activities | Number of Activities | Workload |
| Course Hours | 14 | 28 |
| Study Hours Out of Class | 14 | 42 |
| Midterms | 2 | 4 |
| Final | 1 | 2 |
| Total Workload | 76 | |