Course Information


Course Information
Course Title Code Semester L+U Hour Credits ECTS
METHOD DEVELOPMENT AND VALIDATION IN ANALYTICAL APPLICATIONS OF MILK AND DAIRY PRODUCTS 801800735040 3 + 0 3.0 8.0

Prerequisites None

Language of Instruction English
Course Level Graduate Degree
Course Type Compulsory
Mode of delivery
Course Coordinator
Instructors
Assistants
Goals In the scientific studies carried out in modern technology, there is a necessity on developing new qualitative/ quantitative methods about the determination of some metabolites and components which cannot be detected by classical methods in the analyzed sample by the instrumental equipments. It has become necessary to carry out special method development and validation studies with high sensitivity according to the analyte-matrix status, in case the methods in the literature are insufficient in recent years both for the required innovative researches and for the acceptance of the results as a publication in high impact factor journals. It is also possible to develop new methods directly or to revise and adapt some of the existing methods according to the analyte-matrix pair that we aimed to determine. In this context, it is seen as an important subject that graduate students should learn.
Course Content In case of a deficiency in the literature of dairy analysis, new method can be developed or changes can be made by applying analytical method development techniques according to our own matrix-analyte properties and instrument infrastructure and suitability. Validation, is simply the process of establishing the characteristics of a method in terms of its performance and also describing its limitations. Once the properties of a method have been determined (ie, validated), the characteristics should be compared for the purpose of measuring the consistency of the method with the requirements of the method. In this context, following the lecturing of basic definitions and terminology of method development and validation, examples will be given by instrumental devices on different matrices and analytes.
Learning Outcomes 1) Participants of this course are expected to be familiar with the basic terms related to method development and validation
2) Participants of this course are expected to have sufficient knowledge on method development and validation in analytical applications and to apply these knowledge in scientific / industrial studies.
3) Participants of this course are expected to perform the analytical data evaluation, method development and method validation on different matrix and analytes by instrumental devices
4) Participants of this course are expected to have knowledge about basic descriptions and terminology, properties of method performances, validation procedures, uncertainty of measurement, recovery and documentation in analytical applications

Weekly Topics (Content)
Week Topics Teaching and Learning Methods and Techniques Study Materials
1. Week What is an analytical method? Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
2. Week Basic definitions and terminology used for method development and validation: Qualitative / Quantitative Analysis, Matrix-Analyte, Certified Reference material (CRM), Noise, Signal / Noise Ratio, Robustness / Strength, Blind sample, Clean-up, Stock Solution, Internal Standard, External Standard, Calibration Curve, Sample preparation. Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
3. Week Method Performance Properties 1: Observability / Limit of Detection (LOD), Detectability / Limit of Determination (LOQ), Accuracy, Linearity, Precision Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
4. Week Method Performance Properties 1: Repeatibility, Reproducibility, Sensivity and Selectivity, Linearity Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
5. Week What is Method Development? How to apply? What does method optimization mean? Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
6. Week What is Method Validation? How to apply? What are the validation criteria Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
7. Week Midterm Exam

8. Week What is Method Documentation (Standard Operating Procedure - SOP)? How is it prepared? What is Validation SOP? Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
9. Week In-house or single laboratory validation and peer verified method validation Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
10. Week Interlaboratory validation, re-validation and relation between validation and accreditation Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
11. Week Quality Assurance and Analytical Quality Assurance Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
12. Week Evaluation of analytical data, measurement uncertainty, error during measurement, recovery Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
13. Week Case study 1: Method development and validation for Aflatoxin M1 determination in cheese (IAC cleaning by HPLC and post-column bromination method) Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)
14. Week Case study 2: Method development and validation for determination of fatty acid composition in milk (Fatty acid methyl ester (FAME) method by GC) Lecture; Question Answer; Problem Solving; Discussion
Brainstorming; Opinion Pool; Colloquium
Project Based Learning; Problem Based Learning 		Presentation (Including Preparation Time) Practice (Teaching Practice, Music/Musical Instrument Practice, Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice)

Sources Used in This Course
Recommended Sources
Ashok Kumar, Lalit Kishore, Navpreet Kaur, Anroop Nair. 2012. Method development and validation: Skills and tricks. Chronicles of Young Scientists 3(1):3-11.
Hamide Z. Şenyuva, John Gilbert. 2006. Metot geliştirme ve validasyonu. ISBN: 975-00884-0-9, Ankara.
Michael E. Swartz, Ira S. Krull. 1997. Analytical Method Development and Validation 1st Edition, CRC Press.
Ravisankar, P., Navya, N., C., Pravallika1, D., Navya Sri, D.2015. A Review on Step-by-Step Analytical Method Validation. IOSR Journal Of Pharmacy, 5(10): 07-19.

ECTS credits and course workload
Event Quantity Duration (Hour) Total Workload (Hour)
Course Duration (Total weeks*Hours per week) 14 3
Work Hour outside Classroom (Preparation, strengthening) 14 3
Homework 10 5
Presentation (Including Preparation Time) 4 4
Report (Including Preparation and presentation Time) 10 5
Practice (Teaching Practice, Music/Musical Instrument Practice , Statistics, Laboratory, Field Work, Clinic and Polyclinic Practice) 3 2
Time to prepare for Quiz 3 2
Midterm Exam 1 2
Time to prepare for Midterm Exam 1 10
Final Exam 1 2
Time to prepare for Final Exam 1 10
Total Workload
Total Workload / 30 (s)
ECTS Credit of the Course
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Course Information
  • Course Information
  • Weekly Topics (Content)
  • Sources Used in This Course
  • ECTS credits and course workload