TYPE OF COURSE UNIT	Elective Course
LEVEL OF COURSE UNIT	Bachelor's Degree
YEAR OF STUDY	-
SEMESTER	-
NUMBER OF ECTS CREDITS ALLOCATED	2
NAME OF LECTURER(S)	Professor Miyase Nilüfer Tarımcı Professor Fatma Nevin Çelebi
LEARNING OUTCOMES OF THE COURSE UNIT	At the end of this course, the students; 1) Learn the development process and stages of a new drug. 2) Learn R&D studies in the development of a new and generic formulations 3) Learn the pharmaceutical processes regarding to develop a new and generic formulation. 4) Acquire knowledge about technology transfer. 5) Learn the knowledge regarding to scale up process from lab scale to pilot and industrial scale 6) Transfer the knowledge and skills gained in R&D studies to the pharmaceutical industry. 7) Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life. 8) Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
MODE OF DELIVERY	Face to face
PRE-REQUISITES OF THE COURSE	No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT	None
COURSE DEFINITION	It covers the importance of R&D studies in the pharmaceutical industry, R&D studies conducted in the development of new and generic drug forms, pharmaceutical scale up studies, technology transfer.
COURSE CONTENTS	WEEK TOPICS 1st Week The importance of R & D studies in pharmaceutical industry, the current situation in Turkey and in the world 2nd Week Types of innovation in the pharmaceutical industry (incremental, stepwiswise,breakthrough) 3rd Week The role of stakeholders (public, industry, university) in R&D and innovation 4th Week New drug development process and stages 5th Week R&D studies in the development of new and generic dosage formsformulation 6th Week Basic rules in the selection of candidate drugs and excipients 7th Week MID TERM EXAMINATION 8th Week The importance of cell culture studies in drug development 9th Week In silico models in drug development 10th Week Pharmaceutical scale-up studies in the development of new and generic product formulation 11th Week Scale-up in solid dosage forms (Tablets, Capsules) 12th Week Scale up in Parenteral dosage forms 13th Week Scale up in demi solid dosage forms 14th Week Technology transfer
RECOMENDED OR REQUIRED READING	1. Lecturer notes 2. Pharmaceutical Process Scale-Up (Drugs and the Pharmaceutical Sciences), Ed: M Levin, Marcel Dekker Inc., New York, 2001.
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS	Lecture,Discussion
ASSESSMENT METHODS AND CRITERIA	Quantity Percentage(%) Mid-term 1 40 Total(%) 40 Contribution of In-term Studies to Overall Grade(%) 40 Contribution of Final Examination to Overall Grade(%) 60 Total(%) 100
ECTS WORKLOAD	Activities Number Hours Workload Midterm exam 1 2 2 Preparation for Quiz 0 0 0 Individual or group work 14 1 14 Preparation for Final exam 1 8 8 Course hours 14 2 28 Preparation for Midterm exam 1 6 6 Laboratory (including preparation) 0 0 0 Final exam 1 2 2 Homework 1 5 5 Total Workload 65 Total Workload / 30 2,16 ECTS Credits of the Course 2
LANGUAGE OF INSTRUCTION	Turkish
WORK PLACEMENT(S)	No