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Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS TRT 5024 PRECLINICAL RESEARCH AND TOXICITY TESTS COMPULSORY 2 0 0 6

Offered By

TRANSLATIONAL MEDICINE

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR MUALLA AYLIN ARICI

Offered to

TRANSLATIONAL MEDICINE

Course Objective

Knowing the basics of preclinical research and toxicity tests.

Learning Outcomes of the Course Unit

1   Defines general concepts, toxic dose and dose-response relationships in toxicology. 2   Describes the basics of general toxicity testing 3   Learns the basics of special toxicity tests. 4   Describes the basics of toxicokinetic/pharmacokinetic studies in experimental animals 5   It defines the in-vitro and in-vivo safety of the active substance.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description 1 Fundamentals of Good Laboratory Practices 2 General concepts in toxicology (LD50, MTD and NOEL), Toxic dose, dose-response relationship 3 Fundamentals and evaluation of acute toxicity tests 4 Subacute/subchronic toxicity tests, basic principles and evaluation 5 Chronic toxicity tests, basic principles and evaluation 6 Evaluation of autopsy findings of the experimental animal in toxicity tests (gross necropsy) 7 Presentation 8 Basic principles and evaluation of local tolerance studies (irritation and sensitization) 9 Immunotoxicity studies, basic principles and evaluation 10 Reproductive toxicity studies, basic principles and evaluation 11 Carcinogenicity studies, basic principles and evaluation 12 Determination of bioavailability of the active substance in experimental animals and general principles of pharmacokinetic/toxicokinetic studies 13 Safety tests: evaluation of the in-vivo and in-vitro safety of the 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

It is evaluated with homework + final exam.

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA 1 ASG ASSIGNMENT 2 FIN FINAL EXAM 3 FCG FINAL COURSE GRADE ASG * 0.50+ FIN* 0.50 4 RST RESIT 5 FCGR FINAL COURSE GRADE (RESIT) ASG * 0.50+ RST* 0.50

Further Notes About Assessment Methods

None

Assessment Criteria

To be announced.

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

To be announced.

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 7 98 Preparing assignments 1 18 18 Final 1 3 3 TOTAL WORKLOAD (hours) 147

Contribution of Learning Outcomes to Programme Outcomes

PO/LO PO.1 PO.2 PO.3 PO.4 PO.5 PO.6 PO.7 PO.8 PO.9 LO.1 5 5 5 5 5 5 5 LO.2 5 5 5 5 5 5 5 LO.3 5 5 5 5 5 5 5 5 LO.4 5 5 5 5 5 5 5 5 LO.5 5 5 5 5 5 5 5 5