Preclinical Studies in Drug Development
| Title | Προκλινικές μελέτες στην ανάπτυξη των φαρμάκων / Preclinical Studies in Drug Development |
| Code | ΙΜΒ033 |
| Faculty | Health Sciences |
| School | Medicine |
| Cycle / Level | 2nd / Postgraduate |
| Teaching Period | Spring |
| Coordinator | Antonis Goulas |
| Common | No |
| Status | Active |
| Course ID | 600013246 |
Programme of Study: PMS Ereunītikī Methodología stīn Iatrikī kai stis Epistīmes Ygeías (2021-sīmera)
Registered students: 6
| Orientation | Attendance Type | Semester | Year | ECTS |
|---|---|---|---|---|
| KORMOS | Elective Courses | 2 | 1 | 7.5 |
| Vasikīs Iatrikīs Éreunas | Elective Courses | 2 | 1 | 7.5 |
| Klinikīs Iatrikīs Éreunas | Elective Courses | 2 | 1 | 7.5 |
| Academic Year | 2025 – 2026 |
| Class Period | Spring |
| Faculty Instructors | |
| Instructors from Other Categories | |
| Class ID | 600288929
|
Course Type 2021
Specific Foundation
Mode of Delivery
- Face to face
- Distance learning
Digital Course Content
- e-Study Guide https://qa.auth.gr/en/class/1/600288929
Erasmus
The course is also offered to exchange programme students.
Language of Instruction
- Greek (Instruction, Examination)
- English (Instruction, Examination)
Prerequisites
General Prerequisites
Background knowledge in pharmacology, biochemistry and molecular biology
Learning Outcomes
Upon succesfully completing this course, students will have acquired a global perception of the proclinical stage of drug discovery and development. They will be able to understand the basic criteria and requirements of translational research at a theoretical, experimental and regulatory level.
In addition, students will be able to design and evaluate results from in vitro and in vivo assays for validating pharmacological targets and the efficacy and toxicity of new chemical entities (candidate drugs).
General Competences
- Apply knowledge in practice
- Retrieve, analyse and synthesise data and information, with the use of necessary technologies
- Make decisions
- Work autonomously
- Work in teams
- Work in an international context
- Generate new research ideas
- Be critical and self-critical
- Advance free, creative and causative thinking
Course Content (Syllabus)
Introduction to drug discovery and development
Early stages: discovery of candidate molecules - natural products - making use of biodiversity
Drug repurposing - discovery of novel targets with the assistance of proteomics and systems biology
The use of cell cultures in preclinical studies - advantages and disadvantages
The use of laboratory animals in preclinical studies - advantages and disadvantages
Animal models of neurodegenerative diseases
Interim evaluation - short presentations
Preclinical development of advanced therapy medicinal products (ATMPs)
Preclinical vaccine development
Early safety studies
Τoxicity control - safety evaluation
Animal models of behavior
Biotransformation and pharmacogenetic studies
Control and regulation of preclinical studies
Recap
Final evaluation - Παρουσιάσεις εργασιών
Keywords
Preclinical studies, drug discovery, drug development, new chemical entities, natural products, drug repurposing, drug safety
Educational Material Types
- Slide presentations
- Scientific publications
Use of Information and Communication Technologies
Use of ICT
- Use of ICT in Course Teaching
- Use of ICT in Communication with Students
- Use of ICT in Student Assessment
Course Organization
| Activities | Workload | ECTS | Individual | Teamwork | Erasmus |
|---|---|---|---|---|---|
| Lectures | 30 | ✓ | ✓ | ||
| Reading Assigment | 100 | ✓ | ✓ | ||
| Written assigments | 60 | ✓ | ✓ | ||
| Total | 190 |
Student Assessment
Description
Interim evaluation with short presentation (10%)
Final evaluation with detailed presentation (40%)
Final evaluation with written report (50%)
Student Assessment methods
- Written Assignment (Summative)
- Performance / Staging (Formative, Summative)
Bibliography
Additional bibliography for study
Hughes JP et al. Principles of early drug discovery. Br J Pharmacol. 2011; 162: 1239-1249
Jensen PR. Natural products and the gene cluster revolution. Trends Microbiol. 2016; 24: 968-977
Arrigoni C & Crivori P. Assessment of QT liabilities in drug development. Cell Biol Toxicol. 2007; 23: 1-13
Rendic SP & Guenderich FP. Human family 1-4 cytochrome P450 enzymes involved in the metabolic activation of xenobiotic and physiological chemicals: an update. Arch Toxicol. 2021; 95: 395-472
Henderson CJ et al. An Extensively Humanized Mouse Model to Predict Pathways of Drug Disposition and Drug/Drug Interactions, and to Facilitate Design of Clinical Trials. Drug Metab Dispos. 2019; 47: 601-615
Bell CC et al. Characterization of primary human hepatocyte spheroids as a model system for drug-induced liver injury, liver function and disease. Sci Rep 2017; 6: 25187
Bizat N et al. An in vivo Caenorhabditis elegans model for therapeutic research in human prion diseases. Brain 2021; 144: 2745-2758
Methods of Behavior Analysis in Neuroscience, 2nd edition. Editor: Jerry J Buccafusco. https://www.ncbi.nlm.nih.gov/books/NBK5228/
Planchez B et al. Animal models of major depression: drawbacks and challenges. J Neural Trans 2019; 126: 1383-1408
Povia et al. Vaccine development: Current trends and technologies. Life Sciences 2024; 336: 122331
JW Kille. Regulatory Toxicology, in: A Comprehensive Guide to Toxicology in Nonclinical Drug Development. Elsevier 2017
Last Update
27-12-2023
