Course Information

Course Name	Turkish	İlaç Endüstrisine Giriş
	English	Introduction to Pharmaceutical Industry
Course Code	KIM 558	Credit	Lecture (hour/week)	Recitation (hour/week)	Laboratory (hour/week)
Semester	-	-	3	-	-
Course Language		Turkish
Course Coordinator		Emine Naciye Talınlı
Course Objectives		I. To give information about the techniques, methods and concepts used in pharmaceutical industry II. To give information about regulations in the API production III. To give information about Polymorphism and relationship between polymorphism and active . pharmaceutical ingredients(API) IV. To inform about Patents and practice in the pharmaceutical industry V. To give information about Drug Master File and its preparation
Course Description		General informations, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Patents and Applications in the Pharmaceutical Industry, Polymorphism in the Active Pharmaceutical Ingredients (API), ICH guidelines(Limits, Force Degradation Studies (FDS), Classification of Areas, Stability, Drug Master File (DMF), Pharmacopeias (USP, EP, JP), Validations (Process, Method), Process Risk analysis
Course Outcomes		M.Sc./Ph.D. students who successfully pass this course gain knowledge, skill and competency in the following subjects; They learn the concepts used in pharmaceutical industry. They get knowledge about techniques and practice used in production of active pharmaceutical, and the regulations in the pharmaceutical industry. They get basic knowledge related patent and polymorphism.
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