| Pharmacy (English) | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
| Course Code: | PHA028 | ||||
| Course Name: | Biomarkers in Pharmaceutical Research and Development | ||||
| Semester: | Fall | ||||
| Course Credits: |
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| Language of instruction: | |||||
| Course Condition: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Departmental Elective | ||||
| Course Level: |
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| Mode of Delivery: | Face to face | ||||
| Course Coordinator: | Prof. Dr. MEHMET FERİT İSBİR | ||||
| Course Lecturer(s): | Prof. Dr. Mehmet F. İsbir | ||||
| Course Assistants: |
| Course Objectives: | The aim of this course is to give information about the biomarkers used to overcome the financial and time-related difficulties of new drug development and research studies, which is a very costly and long-term process. |
| Course Content: | Biomarker definitions and their applications As a clinical outcome for biomarker. A type of symptom considered as biomarker Endpoints as a biomarker, surrogate end point Types of biomarker, whit it is important? Diagnostic biomarker Predictive biomarker Prognostic biomarker Safety biomarker Prognostic versus predictive biomarker Drug development and research Validation of Analytic Methods for Biomarkers Used in Drug Development Future of digital biomarker |
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The students who have succeeded in this course;
1) At the end of this course, the students will learn and understand biomarker definitions and applications. 2) At the end of this course, the students will learn and understand as a clinical outcome for biomarker an a type of symptom considered as biomarker. 3) At the end of this course, the students will learn and understand endpoints as a biomarker, surrogate end point. 4) At the end of this course, the students will learn and understand biomarker types and understands the importance of biomarkers. 5) At the end of this course, students define diagnostic biomarkers and give examples. 6) At the end of this course, students define prognostic biomarkers and give examples. 7) At the end of this course, students define safety biomarkers and give examples. 8) At the end of this course, students define prognostic versus predictive biomarker and give examples. 9) At the end of this course, the students learns the stages of drug research and development studies 10) At the end of this course, the students learns the validation of analytical methods for biomarkers used in drug development 11) At the end of this course, students learn and discuss the future of digital biomarkers. |
| Week | Subject | Related Preparation |
| 1) | Biomarker definitions and their applications | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 2) | As a clinical outcome for biomarker. A type of symptom considered as biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 3) | Endpoints as a biomarker, surrogate end point | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 4) | Types of biomarker, whit it is important? | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 5) | Diagnostic biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 6) | Predictive biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 7) | Predictive biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 8) | Safety biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 9) | Prognostic versus predictive biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 10) | Drug development and research | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 11) | Validation of Analytic Methods for Biomarkers Used in Drug Development | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| 12) | Future of digital biomarker | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| Course Notes / Textbooks: | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| References: | Pharmacological and Toxicological Importance of Biomarkers in New Drug Investigations-Mehmet F. İsbir Biomarker definitions and their applications-Robert M Califf Pharmacotherapy- A Pathophysiologic Approach |
| Course Learning Outcomes | 1 |
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11 |
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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) 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. | |||||||||||
| 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. | |||||||||||
| 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. | |||||||||||
| 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 | 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 | 3 | 3 | 3 |
| 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. | 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 |
| 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. | |
| 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. | |
| 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 |
| 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 | |
| Activities | Number of Activities | Workload |
| Course Hours | 14 | 28 |
| Study Hours Out of Class | 14 | 38 |
| Midterms | 1 | 2 |
| Final | 1 | 2 |
| Total Workload | 70 | |