FAHL1_14 Preclinical and Clinical Trials of Medicines

Faculty of Pharmacy
Autumn 2024

The course is not taught in Autumn 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)
Guaranteed by
PharmDr. Bc. Kateřina Horská, Ph.D.
Department of Pharmacology and Toxicology – Departments – Faculty of Pharmacy
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.
fields of study / plans the course is directly associated with
Course objectives
Research and development of new drugs is a multidisciplinary procedure in which many different disciplines like chemistry, biology, pharmacy, medicine as well as sociology, economy and law play their important role. Pharmacology is crucial both in preclinical and iclinical phases.
The target of the subject "Preclinical and Clinical Drug Research and Development" gives handy basic information on practical aspects of drug evaluation in the mentioned phases with the aim to enlarge knowledge of pharmacy students so they will be able to start their careers also in R&D departments.
Syllabus
  • Lectures Content
    1. Biological activity testing, evidence of activity on the target cells, test on organs and whole organism, ethical aspects of preclinical studies - legal status, ethics commitee ,good laboratory practice.
    2. Tolerability testing , toxicity tests - acute, subchronical and chronical toxicity, toxicity of reproduction. Data transfer possibility from animals to human- biological similarity. Pharmacokinetic and bioequivalence studies.
    3. Clinical trials as a part of clinical research, phases of clinical trials, their organise and specific aspects, primary and secundary objectives, parametres for effects and tolerability evaluation. Metodological aspects of clinical trials, Good Clinical Practice - principes, harmonization, terminology, SOP, monitoring, zacházení s hodnocenými vzorky, důvěrnost údajů, zajišťování kvality, audity, inspection, data clarification. Essential dokuments - protocol, CRF, IS.
    4. Principles of statistical analyses used in clinical research - basic terminology, randomization, study design, hypotheses, statistical tests, statistical analyses results interpretation.
    5. Legal aspects , fundamental and related acts. Legaly requested activities of sponzor, investigator, trial subjekt. Contract research organisation . Contracts, fees, instance in clinical trials. Prerequisites for open clinical trial, regulatory and ethics committees requests . Ethical aspects , Czech nett of ethics committees and theire activities, Standard operating procedures, necessary documents.
    6. Compliance and control mechanism. Sponsor, monitor and investigator responsibilities . Pharmacovigilance, adverse event and drug reaction.
    7. Possible use of nonregistered drugs. Cooperation between pharmacy and organisers in clinical trials. 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
Teaching methods (in Czech)
Monologická (výklad, přednáška, instruktáž)
Dialogická (diskuze, rozhovor, brainstorming)
Assessment methods (in Czech)
Známkou
Ústní zkouška
Language of instruction
English
Further comments (probably available only in Czech)
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.
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