FaF:F1HL1_14 Preclinical and Clinical Trial - Course Information
F1HL1_14 Preclinical and Clinical Trials of Medicines
Faculty of PharmacyAutumn 2024
- Extent and Intensity
- 1/0/0. 2 credit(s). Type of Completion: zk (examination).
In-person direct teaching - Teacher(s)
- PharmDr. Bc. Kateřina Horská, Ph.D. (lecturer)
doc. MVDr. Pavel Suchý, Ph.D. (lecturer)
prof. MUDr. Bc. Libor Ustohal, Ph.D. (lecturer) - Guaranteed by
- PharmDr. Bc. Kateřina Horská, Ph.D.
Department of Pharmacology and Toxicology – Departments – Faculty of Pharmacy
Supplier department: Department of Pharmacology and Toxicology – Departments – Faculty of Pharmacy - Timetable
- Mon 11. 11. to Fri 15. 11. Wed 16:35–18:15 44-056, Mon 18. 11. to Fri 6. 12. Wed 16:35–19:05 44-056, Mon 9. 12. to Fri 13. 12. Wed 16:35–18:15 44-056
- Prerequisites
- FAKULTA(FaF) || OBOR(MUSFaF)
Basic knowledge of general pharmacology, pharmacological terminology. - Course Enrolment Limitations
- The course is only offered to the students of the study fields the course is directly associated with.
The capacity limit for the course is 50 student(s).
Current registration and enrolment status: enrolled: 45/50, only registered: 0/50 - fields of study / plans the course is directly associated with
- Pharmacy (programme FaF, M-FARM)
- Multidisciplinary studies at Faculty of Pharmacy (programme CST, KOS)
- Course objectives
- Research and development of new drugs is a multidisciplinary process in which many different disciplines, e.g., chemistry, biology, pharmacy, medicine, sociology, economy, and law, play an important role. Pharmacology is crucial both in the preclinical and clinical phases. The subject "Preclinical and Clinical Drug Research and Development" provides essential information on practical aspects of drug evaluation in the mentioned phases to upgrade pharmacy students' knowledge so they can start their careers in R&D and regulatory positions.
- Learning outcomes
- After completing the course, the student will be able to - describe drug development and interpret regulatory, legal, and ethical aspects of this process - interpret the main regulatory principles, including pharmacovigilance - Participate in preclinical and clinical drug trials and regulatory activities
- Syllabus
- Lectures Content Biological activity testing, evidence of activity on the target cells, test on organs and the whole organism, animal models, ethical aspects of preclinical studies - legal basis, good laboratory practice. Tolerability testing, toxicity tests - acute, subchronic, and chronic toxicity, the reproduction toxicity. Extrapolation of data from animal models to humans. Pharmacokinetic and bioequivalence studies. Clinical trials are a part of clinical research, phases of clinical trials, design and specific aspects, primary and secondary objectives, parameters for efficacy, and tolerability evaluation. Methodological aspects of clinical trials, Good Clinical Practice - principles, terminology, SOP, monitoring, quality assurance. Essential documents - protocol, etc. Principles of statistical analyses used in clinical research - basic terminology, randomization, study design, hypotheses, statistical analyses, results interpretation. Legal aspects. Activities of sponsor, investigator, and trial subject. Contract research organization. Contracts, fees, and insurance in clinical trials. Regulatory aspects and ethics committees. Ethical aspects. Compliance and control mechanism. Sponsor, monitor, and investigator responsibilities. Pharmacovigilance, adverse event, and adverse drug reaction. Possible use of non-licensed drugs. C Pharmacist activities in drug clinical research.
- Lectures Content Biological activity testing, evidence of activity on the target cells, test on organs and the whole organism, animal models, ethical aspects of preclinical studies - legal basis, good laboratory practice. Tolerability testing, toxicity tests - acute, subchronic, and chronic toxicity, the reproduction toxicity. Extrapolation of data from animal models to humans. Pharmacokinetic and bioequivalence studies. Clinical trials are a part of clinical research, phases of clinical trials, design and specific aspects, primary and secondary objectives, parameters for efficacy, and tolerability evaluation. Methodological aspects of clinical trials, Good Clinical Practice - principles, terminology, SOP, monitoring, quality assurance. Essential documents - protocol, etc. Principles of statistical analyses used in clinical research - basic terminology, randomization, study design, hypotheses, statistical analyses, results interpretation. Legal aspects. Activities of sponsor, investigator, and trial subject. Contract research organization. Contracts, fees, and insurance in clinical trials. Regulatory aspects and ethics committees. Ethical aspects. Compliance and control mechanism. Sponsor, monitor, and investigator responsibilities. Pharmacovigilance, adverse event, and adverse drug reaction. Possible use of non-licensed drugs. C Pharmacist activities in drug clinical research.
- Literature
- required literature
- Strnadová Věra. Skriotum: Minimum pro klinické hodnocení léčiv. VFU Brno, 2006. ISBN 80-7305-560-0. info
- not specified
- Aktuální platná legislativa
- zdroje SÚKL
- Teaching methods
- Monologue (reading, lecture, briefing) Discussion, interview, brainstorming
- Assessment methods
- Completion of the course – oral exam
- Language of instruction
- Czech
- Further comments (probably available only in Czech)
- Study Materials
The course can also be completed outside the examination period. - Teacher's information
- Participation at lectures 60% at least and knowledge of recomended literature. Final examination.
- Enrolment Statistics (recent)
- Permalink: https://is.muni.cz/course/pharm/autumn2024/F1HL1_14