Ders Bilgileri

#### Ders Tanımı

Ders Kodu Yarıyıl T+U Saat Kredi AKTS
ANALYTICAL METHOD VALIDATION KIM 509 0 3 + 0 3 6
 Dersin Dili Türkçe Dersin Seviyesi Yüksek Lisans Dersin Türü SECMELI Dersin Koordinatörü Doç.Dr. CAN SERKAN KESKİN Dersi Verenler Doç.Dr. CAN SERKAN KESKİN Dersin Yardımcıları Department research assistants Dersin Kategorisi Dersin Amacı 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. Dersin İçeriği 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
 Dersin Öğrenme Çıktıları Öğretim Yöntemleri Ölçme Yöntemleri 1 - Judges how to do of the validation works 1 - 2 - 4 - 12 - 14 - 15 - A - B - C - 2 - Evaluates how to calculate validation parameters. 1 - 2 - 4 - 12 - 14 - 15 - A - B - C - 3 - Judges how to evaluate of obtained data experimentally. 1 - 2 - 4 - 12 - 14 - 15 - A - B - C - 4 - Judges how to interpret of experiment results in terms of statistics. 1 - 2 - 4 - 12 - 14 - 15 - A - B - C - 5 - Evaluates the topics of data analysis in chemistry. 1 - 2 - 4 - 12 - 14 - 15 - A - B - C -
 Öğretim Yöntemleri: 1:Lecture 2:Question-Answer 4:Drilland Practice 12:Case Study 14:Self Study 15:Problem Solving Ölçme Yöntemleri: A:Testing B:Oral Exam C:Homework

#### Ders Akışı

Hafta Konular ÖnHazırlık
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.

#### Kaynaklar

Ders Notu

Prepared weekly lesson presentations.

Ders Kaynakları

[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.

#### Dersin Program Çıktılarına Katkısı

No Program Öğrenme Çıktıları KatkıDüzeyi
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
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
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.
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).
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
10 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
11 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
12 - 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
13 -Transfer the current developments and his/her studies to the other related or nonrelated groups as written, orally and visually. X
14 - Develops new strategic approach and produces solutions in unexpected and complicated situations in his or her area of practice. X
15 - Develops strategic and practice plans and evaluates the obtained results within the framework of quality process in his or her study area. X
16 - Has written communication ability in one of well known foreign languages (“European Language Portfolio Global Scale”, Level A1). X
17 -Has knowledge for software and hardware about computers and uses data processing. X
18 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
19 - Applies his or her digested knowledge and problem solving ability in advanced studies. X

#### Değerlendirme Sistemi

YARIYIL İÇİ ÇALIŞMALARI SIRA KATKI YÜZDESİ
AraSinav 1 70
Odev 1 15
PerformansGoreviSeminer 1 15
Toplam 100
Yıliçinin Başarıya Oranı 50
Finalin Başarıya Oranı 50
Toplam 100

#### AKTS - İş Yükü

Etkinlik Sayısı Süresi(Saat) Toplam İş yükü(Saat)
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
Performance Task (Laboratory) 0 0 0
Performance Task (Seminar) 1 10 10
Final examination 1 20 20
Toplam İş Yükü 151
Toplam İş Yükü /25(s) 6.04
Dersin AKTS Kredisi 6.04
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