Subjects

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Development and validation of analytical methods for quality assurance of drugs - GDFA12

Title:	Vývoj a validace analytické metody pro zajištění kvality léčiv
Guaranteed by:	Department of Analytical Chemistry (16-16140)
Faculty:	Faculty of Pharmacy in Hradec Králové
Actual:	from 2021
Semester:	both
Points:	0
E-Credits:	0
Examination process:	oral
Hours per week, examination:	0/0, Ex [HT]
Capacity:	winter:unknown / unknown (unknown) summer:unknown / unknown (unknown)
Min. number of students:	unlimited
4EU+:	no
Virtual mobility / capacity:	no
Key competences:
State of the course:	taught
Language:	Czech
Teaching methods:	full-time
Level:
Note:	course is intended for doctoral students only enabled for web enrollment you can enroll for the course in winter and in summer semester

Guarantor:	doc. PharmDr. Ludmila Matysová, Ph.D.

Examination dates WS schedule

Annotation -

The aim of the course is to apprise the students of the complex procedure as well as differences in the development of analytical method for Active Pharmaceutical Ingredients (API), pharmaceuticals and also for evaluation of drugs and their metabolites in biological materials. Attention is also paid to understanding of the validation process according to valid guidelines.

Last update: Matysová Ludmila, doc. PharmDr., Ph.D. (24.09.2021)

Literature - Czech

Doporučená:

Snyder, Lloyd R. Kirkland, Joseph Jack Dolan, John W. Dolan. Introduction to modern liquid chromatography. Oxford: Wiley-Blackwell, 2009, 912 s. ISBN 978-0-470-16754-0.

Nováková, Lucie, Douša, Michal. Moderní HPLC separace v teorii a praxi. Praha: Europrint, 2013, 233 s. ISBN 978-80-260-4244-0.

ICH validation guidelines

EMA guidelines

Státní ústav pro kontrolu léčiv

Last update: prepocet_literatura.php (19.09.2024)

Requirements to the exam -

Workflow of the development of analytical methods for Active Pharmaceutical Ingredients (API), pharmaceuticals and also for the evaluation of drugs and their metabolites in biological material. Commonly used validation parameters. Comparison of method development and validation procedures of analytical methods for a specific purpose. Institutions and regulations that provide a legislative framework for the development and validation of analytical methods in the field of pharmaceutical analysis.

Last update: Matysová Ludmila, doc. PharmDr., Ph.D. (24.09.2021)