COURSE UNIT TITLE

: PRECLINICAL RESEARCH AND TOXICITY TESTS

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
TRT 5004 PRECLINICAL RESEARCH AND TOXICITY TESTS COMPULSORY 2 0 0 3

Offered By

TRANSLATIONAL MEDICINE

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR ŞULE KALKAN

Offered to

TRANSLATIONAL MEDICINE

Course Objective

To know principles of preclinical research and toxicity tests.

Learning Outcomes of the Course Unit

1   To define general concept of toxicology, toxic dose and dose-response relationship.
2   To learn principles of good laboratory practice.
3   To define principles of general toxicity tests.
4   To learn principles of specific toxicity test.
5   To define principles of toxicokinetic/pharmacokinetic studies in experimental animal
6   To define in-vitro and in-vivo safety of active substance.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 General concept of toxicology (LD50, MTD ve NOEL ), toxic dose and dose-response relationship.
2 The principles of Good Laboratory Practice
3 Acute toxicity tests: the basic principles and evaluation
4 Subacute /subchronic toxicity tests: the basic principles and evaluation
5 Chronic toxicity tests: the basic principles and evaluation
6 Histopatological evaluation of toxicity tests
7 In toxicity tests: Evaluation of autopsy finding in experimental animals (gross necropsy)
8 In- vitro penetration and in-vivo absorption studies: the basic principles and evaluation
9 Local tolerance studies (irritation and sensitization): the basic principles and evaluation
10 Immunotoxicity studies: the basic principles and evaluation
11 Reproductive toxicity studies: the basic principles and evaluation
12 Genotoxicity, cytotocity and mutagenicity studies: the basic principles and evaluation
13 Carcinogenicity studies: the basic principles and evaluation In experimental animals: Determination of bioavailability of the active substance and general principles of pharmacokinetic and toxicokinetic studies
14 Safety tests : to evaluation in-vitro and in-vivo safety of active substance

Recomended or Required Reading

1. Good Laboratory practice (GLP) handbook. World Health Organization. (e-book)
2. Preclinical toxicology- Guidance Pasific BioLabs.
3. VMTH anatomic pathology senior student rotation handbook. Veterinary medical teaching hospital (e-book)
4. OECD guidelines

Planned Learning Activities and Teaching Methods

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 ASG ASSIGNMENT
2 FIN FINAL EXAM
3 FCGR FINAL COURSE GRADE ASG * 0.40 + FIN* 0.60
4 RST RESIT
5 FCGR FINAL COURSE GRADE (RESIT) ASG * 0.40 + RST* 0.60


*** Resit Exam is Not Administered in Institutions Where Resit is not Applicable.

Further Notes About Assessment Methods

None

Assessment Criteria

Homework and final exam

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

Prof. Yesim TUNCOK (Dokuz Eylul University, School of Medicine, Department of Pharmacology)
Prof. Ayse Gelal (Dokuz Eylul University, School of Medicine, Department of Pharmacology)
Prof. Sule KALKAN (Dokuz Eylul University, School of Medicine, Department of Pharmacology)
Prof. Mukaddes GUNELI (Dokuz Eylul University, School of Medicine, Department of Pharmacology)
Prof. Hilmi Orhan (Ege University, Faculty of Pharmacy, Department of Pharmaceutical Toxicology)
Prof. Hande Gurer Orhan (Ege University, Faculty of Pharmacy, Department of Pharmaceutical Toxicology)

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 2 28
Preparations before/after weekly lectures 14 2 28
Preparation for final exam 1 10 10
Preparing assignments 1 8 8
Final 1 1 1
TOTAL WORKLOAD (hours) 75

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9
LO.15553555
LO.25553555
LO.355553555
LO.455553555
LO.555553555
LO.655553555

CONTACT INFORMATION
Dokuz Eylül Üniversitesi Cumhuriyet Bulvarı No: 144 35210 Alsancak / İZMİR
Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

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