COURSE UNIT TITLE

: NEW DRUG DEVELOPMENTS

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
KIA 5006 NEW DRUG DEVELOPMENTS COMPULSORY 2 0 0 8

Offered By

CLINICAL DRUG RESEARCH

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

PROFESSOR DOCTOR YEŞIM TUNÇOK

Offered to

CLINICAL DRUG RESEARCH
TRANSLATIONAL MEDICINE

Course Objective

To learn the process of drug development from the molecule to the counter; to learn about pre-clinical and clinical studies; planning and conducting these studies.

Learning Outcomes of the Course Unit

1   To know and to be able to implement the national and international regulations in clinical
2   To know and to be able to implement clinical trial design
3   To know and to be able to implement and interpret the fundemental biostatistical concepts
4   To be able to evaluate clinical trial protocol as a member of ethic committee
5   To know the responsibilities of participants in clinical trials
6   To be able to evaluate clinical
7   To be able to evaluate the results of pre-clinical studies trial phase

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 The source of new drug development
2 Pre-clinical trials (screening tests; pharmacologic studies)
3 Pre-clinical trials (acute and chronic toxicity studies)
4 Pre-clinical trials (special toxicity studies)
5 Phase I clinical trials
6 Phase II clinical trials
7 Phase III clinical trials
8 Pharmaceutical development studies
9 Phase IV clinical trials
10 Observational studies
11 Bioavailability/bioequivalence studies
12 Placebo use in clinical trials
13 Drug safety in clinical trials
14 The role of laboratory in clinical trails; Good Laboratory Practice

Recomended or Required Reading

Basic and Clinical Pharmacology. B.Katzung. Appleton & Lange. 13th ed. 2011.
Clinical Pharmacology. PN Bennet, MJ Brown. 10th ed.2008.
Principles of Clinical Pharmacology. AJ Atkinson. 2007
http://ocw.jhsph.edu/index.cfm/go/viewCourse/course/drugdevelopment/coursePage/index/
Hughes JP, Rees S, Kalindjian SB, Philpott KL. Principles of early drug discovery. Br J Pharmacol. 162(6):1239-49; 2011


Klinik Farmakolojinin Esasları ve Temel Düzenlemeler Prof Dr S O Kayaalp 5. Baskı, 2012
Klinik Araştırmalar Kitabı-2014 Editörler: Prof Dr H Akan, Dr H Ilbars, N Ömeroğlu Çetinkaya. Bilimsel Tıp Yayınevi, Ankara, 2014.
References:

Planned Learning Activities and Teaching Methods

Assessment Methods

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


Further Notes About Assessment Methods

None

Assessment Criteria

To be succesful in final exam and, to present a topic in course outline as a homework

Language of Instruction

Turkish

Course Policies and Rules

To be announced.

Contact Details for the Lecturer(s)

ayse.gelal@deu.edu.tr, Tel: 4123904

Office Hours

To be announced.

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 14 4 56
Preparations before/after weekly lectures 14 8 112
Preparing presentations 1 28 28
Final 1 10 10
TOTAL WORKLOAD (hours) 206

Contribution of Learning Outcomes to Programme Outcomes

PO/LOPO.1PO.2PO.3PO.4PO.5PO.6PO.7PO.8PO.9PO.10
LO.15555544444
LO.25555554444
LO.35355553333
LO.45555555555
LO.55555555555
LO.65355555555
LO.75555255555

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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