TYPE OF COURSE UNIT	Elective Course
LEVEL OF COURSE UNIT	Bachelor's Degree
YEAR OF STUDY	-
SEMESTER	-
NUMBER OF ECTS CREDITS ALLOCATED	2
NAME OF LECTURER(S)	Professor Sacide Altınöz
LEARNING OUTCOMES OF THE COURSE UNIT	At the end of this course, the students; 1) Analytical measurement methods used in Analytical Chemistry knows numerical criteria and other features in method selection. 2) Analytical Meaning of Statistical Parameters and Values and evaluate analytical data. 3) Knows what is the validation of an analytical method, how and when it should be done and what is partial validation. 4) Knows the definition of accuracy, precision, (repeatability), and reality parameters among the parameters for method validation. 5) Calibration and linearity can be calculated. It can select the measurement range, sensitivity (lower and upper detection limit, limit of observability,), working range. 6) Knows the definitions of regression and correlation. Stability, specificity, selectivity.Knows the definition of recovery, rubutness, ruggetness,consistency parameters and can calculate. 7) Make the determination and comparison of validity indicators. 8) Follow Method Validation Practices in Drug Analysis 9) Can use the information learned in this course in the fields of business after graduation.
MODE OF DELIVERY	Face to face
PRE-REQUISITES OF THE COURSE	No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT	None
COURSE DEFINITION	Analytical measurement methods used in drug analysis and the parameters required for analytical methods to be valid and the statistical evaluation and application of these parameters.
COURSE CONTENTS	WEEK TOPICS 1st Week Analytical measurement methods used in Analytical Chemistry 2nd Week Numerical criteria and other features in method selection 3rd Week Analytical Meaning of Statistical Parameters and Their Values, Evaluation of analytical data 4th Week What is the validation of an analytical method? How and in what situations should it be done? What is partial validation? 5th Week Introduction to parameters for method validation 6th Week Accuracy, Precision, (Repeatability), reality 7th Week Midterm exam 8th Week Calibration and Linearity, measurement range, Sensitivity (Lower and upper detection limit, observability limit,), Working range 9th Week Regression and correlation 10th Week Stability, Originality, Selectivity 11th Week Recovery, rubustness,ruggetness 12th Week Determination and comparison of validity indicators 13th Week Validation Applications in Drug Analysis 14th Week Validation Applications in Drug Analysis
RECOMENDED OR REQUIRED READING	1. Sümbüloğlu, K., Sümbüloğlu, V., Biyoistatistik, Hatipoğlu Yayınevi, 7. Baskı, Ankara, 1997. 2. Validation of analytical procedures: Methodology. ICH Harmonised Tripartite Guideline, ICH Steering Committee, 1996. 3. ICH Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology Q2 (R1) Step 4 Version, 2005. 4. Green, J.M., A practical guide to analytical method validation. Analytical Chemistry, 68, 305A-309A, 1996. 5. OTHER RELATED RECENT GUIDES, PAPERS AND BOOKS
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS	Lecture,Discussion,Problem Solving
ASSESSMENT METHODS AND CRITERIA	Quantity Percentage(%) Mid-term 1 40 Assignment 1 10 Total(%) 50 Contribution of In-term Studies to Overall Grade(%) 50 Contribution of Final Examination to Overall Grade(%) 50 Total(%) 100
ECTS WORKLOAD	Activities Number Hours Workload Midterm exam 1 1 1 Preparation for Quiz 0 0 0 Individual or group work 14 1 14 Preparation for Final exam 1 8 8 Course hours 14 2 28 Preparation for Midterm exam 1 4 4 Laboratory (including preparation) 0 0 0 Final exam 1 2 2 Homework 1 4 4 Total Workload 61 Total Workload / 30 2,03 ECTS Credits of the Course 2
LANGUAGE OF INSTRUCTION	Turkish
WORK PLACEMENT(S)	No