Akademik Dersler - Tanıtım


Code - Course Title	KİM595 - Analytical Method Development Validation
Course Type	Elective Courses
Language of Instruction	Türkçe
Laboratory + Practice	3+0
ECTS	6.0
Course Instructor(s)	PROFESÖR ÜLKÜ DİLEK UYSAL ÖZDEMİR
Mode of Delivery	Distance learning
Prerequisites	There is no prerequisite or co-requisite for this course.
Courses Recomended	There is no recommended optional programme component for this course.
Recommended Reading List	Basic HPLC and CE of biomolecules, R. L. Cunico, K. M. Gooding, T. Wehr, Bay Bioanalytical Laboratory, Inc, 1998; 10-HPLC method development of pharmaceuticals, Ed: S. Ahuja, H. Rasmussen, Elsevier,2007, chapter 16: Method validation: M. I. Jimidar, P. Heylen, M. D. Smet; 9-Profiles of drug substances, excipients, and related methodology, volume 37, 2012, chapter 12: validation of analytical methods-update 2011, Gunawan Indrayanto 439-458;
Assessment methods and criteria	a mid-term and a final exam
Work Placement	Not Applicable
Sustainability Development Goals

Weeks	Topics
Week - 1	Method for Chemical Analysis and Its Steps; Quantitative Analysis Steps
Week - 2	Method Qualibration; Analytical Method Development and Validation
Week - 3	Qualification; Good Laboratory Practice (GLP); Current Good Manufacturing Practice (cGMP); ISO 9000 (TickIT)
Week - 4	Method Development, Optimization and Validation Approaches
Week - 5	; Organisations and Guides for method validation
Week - 6	Method Validation: Terminology and Definitions
Week - 7	Precision, Error, Standard Deviation; Confidence Ranges
Week - 8	Statistical Aids to Hypothesis Testing
Week - 9	Method Validation Parameters (ICH/USP)
Week - 10	Accuracy, Precision, Specificity, Limit of Detection
Week - 11	Limit of Quantification, Linearity and Range, Ruggedness, Robustness
Week - 12	Data Elements Required for Assay Validation
Week - 13	System Suitability (USP)
Week - 14	Method Validation Protocol; Method Transfer and Revalidation

Assessment Method and Passing Requirements
	Quamtity	Percentage (%)
2.Midterm Exam	1	40
Final Exam	1	60
Toplam (%)		100