Course Name Code Semester T+U Hours Credit ECTS
Analytical Method Validation KIM 509 0 3 + 0 3 6
Precondition Courses
Recommended Optional Courses
Course Language Turkish
Course Level yuksek_lisans
Course Type Optional
Course Coordinator Doç.Dr. CAN SERKAN KESKİN
Course Lecturers Doç.Dr. CAN SERKAN KESKİN,
Course Assistants

Department research assistants

Course Category
Course Objective

Validation work must be made by all means, before passing to routine usage of a new method and must be repeated in different circumstances. The validity parameters (accuracy, certainty etc.) required to be valid of analytical methods must be analysed. Data obtained as experimental must be assessed and experiment results must be commended in terms of statistics.

Course Content

Description of validation. in which situations, validation should be performed? Analytical Method Validation and criteria. Parameters of validation. Systems proportion tests. Errors and deviations. Deduction of inaccurate results. Result rounding. Statistical comparison of results. Confident limits. Optaining of the calibration curves. Linear regression analysis. Evaluation of resuts. Examples

# Course Learning Outcomes Teaching Methods Assessment Methods
1 Judges how to do of the validation works Lecture, Question-Answer, Drilland Practice, Case Study, Self Study, Problem Solving, Testing, Oral Exam, Homework,
2 Evaluates how to calculate validation parameters. Lecture, Question-Answer, Drilland Practice, Case Study, Self Study, Problem Solving, Testing, Oral Exam, Homework,
3 Judges how to evaluate of obtained data experimentally. Lecture, Question-Answer, Drilland Practice, Case Study, Self Study, Problem Solving, Testing, Oral Exam, Homework,
4 Judges how to interpret of experiment results in terms of statistics. Lecture, Question-Answer, Drilland Practice, Case Study, Self Study, Problem Solving, Testing, Oral Exam, Homework,
5 Evaluates the topics of data analysis in chemistry. Lecture, Question-Answer, Drilland Practice, Case Study, Self Study, Problem Solving, Testing, Oral Exam, Homework,
Week Course Topics Preliminary Preparation
1 Importance and description of validation. in which situations, validation should be performed?
2 Analytical Method Validation and criteria
3 Parameters of validation
4 Systems proportion tests
5 Errors and deviations.
6 Deduction of inaccurate results.
7 Result rounding.
8 Statistical comparison of results
9 intermediate examination
10 Confident limits.
11 Optaining of the calibration curves
12 Linear regression analysis.
13 Evaluation of resuts.
14 Examples.
Resources
Course Notes <p>Prepared weekly lesson presentations.</p>
Course Resources

[1] Yararlandığım kaynaklardan hazırladığım sunu. 

[2] Biyoyararlanım ve Biyoeşdeğerlilik genel İlkeler. 

[3] Ulusal Biyoyararlanım ve Biyoeşdeğerlilik Sempozyumu Kitabı, Şafak Matbaacılık, Ankara, 1994.

[4] SKOOG, D.A., WEST, D.M., HOLLER, F.J., Analitik Kimya Temelleri, Bilim Yayıncılık, Ankara, 1996.

[5] SKOOG, D.A., HOLLER, F.J., NIEMAN, T.A., Enstrümental Analiz, Bilim Yayıncılık, Ankara, 1998.

[6] GÜNDÜZ, T., Instrümental Analiz, Gazi Kitapevi, Ankara, Şubat 2002.

[7] MALM, M., Drug Analysis, Bioanalysis Method Development and Validation, Uppsala University, Sweden, 2008.

Order Program Outcomes Level of Contribution
1 2 3 4 5
1 In addition to expanding and making deeper the knowledge established on undergraduate education in a same or different area, reaches the knowledge by doing research and also improves his or her knowledge to the expertise level by doing evaluation and practice. X
1 In addition to expanding and making deeper the knowledge established on undergraduate education in a same or different area, reaches the knowledge by doing research and also improves his or her knowledge to the expertise level by doing evaluation and practice. X
2 Utilizing incomplete or limited data in his or her study area expands the knowledge by experimental methods and use those obtained knowledge by scientific, social and ethical responsibility. X
2 Utilizing incomplete or limited data in his or her study area expands the knowledge by experimental methods and use those obtained knowledge by scientific, social and ethical responsibility.
3 - Constructs a problem with his/her adviser and develops a solution method and by evaluating the results apply them if it is necessary in his/ her area. X
3 - Constructs a problem with his/her adviser and develops a solution method and by evaluating the results apply them if it is necessary in his/ her area. X
4 -Transfer the current developments and his/her studies to the other related or nonrelated groups as written, orally and visually. X
4 -Transfer the current developments and his/her studies to the other related or nonrelated groups as written, orally and visually.
5 - Develops new strategic approach and produces solutions in unexpected and complicated situations in his or her area of practice.
5 - Develops new strategic approach and produces solutions in unexpected and complicated situations in his or her area of practice. X
6 - Develops strategic and practice plans and evaluates the obtained results within the framework of quality process in his or her study area. X
6 - Develops strategic and practice plans and evaluates the obtained results within the framework of quality process in his or her study area.
7 - Has written communication ability in one of well known foreign languages (“European Language Portfolio Global Scale”, Level A1).
7 - Has written communication ability in one of well known foreign languages (“European Language Portfolio Global Scale”, Level A1). X
8 -Has knowledge for software and hardware about computers and uses data processing. X
8 -Has knowledge for software and hardware about computers and uses data processing. X
9 Protecting scientific, social, and ethical values, teaches and controls these values in the steps of collection, evaluation and announcement of data in the international arena. X
9 Protecting scientific, social, and ethical values, teaches and controls these values in the steps of collection, evaluation and announcement of data in the international arena. X
10 - Applies his or her digested knowledge and problem solving ability in advanced studies. X
Evaluation System
Semester Studies Contribution Rate
1. Ödev 25
1. Ara Sınav 50
1. Performans Görevi (Seminer) 25
Total 100
1. Yıl İçinin Başarıya 40
1. Final 60
Total 100
ECTS - Workload Activity Quantity Time (Hours) Total Workload (Hours)
Course Duration (Including the exam week: 16x Total course hours) 16 3 48
Hours for off-the-classroom study (Pre-study, practice) 16 3 48
Mid-terms 1 15 15
Assignment 1 10 10
Final examination 1 20 20
Performance Task (Seminar) 1 10 10
Total Workload 151
Total Workload / 25 (Hours) 6.04
dersAKTSKredisi 6