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Development, optimization and validation of bioanalytical methods - GDBM09

Title:	Vývoj, optimalizace a validace bioanalytických metod
Guaranteed by:	Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty:	Faculty of Pharmacy in Hradec Králové
Actual:	from 2019
Semester:	both
Points:	0
E-Credits:	0
Examination process:
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
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. RNDr. Lenka Kujovská Krčmová, Ph.D.
Interchangeability :	GDZCH09
Is interchangeable with:	GDZCH09

Examination dates WS schedule SS schedule

Annotation -

Last update: prof. RNDr. Dalibor Šatínský, Ph.D. (01.03.2018)

Subject “Development, optimization and validation of bioanalytical methods” is based on the application of instrumental techniques, mainly chromatographic, for bioanalytical method development with main emphasis on individual steps of this procedure. The important part is method validation especially in bioanalytical point of view. It also deals with the development of validation protocols, rules of validation authorities SÚKL, FDA, and valid procedures for bioanalytical techniques.

Literature - Czech

Last update: prof. RNDr. Dalibor Šatínský, Ph.D. (01.03.2018)

Povinná:

Nováková, Lucie, Douša, Michal. Moderní HPLC separace v teorii a praxi. Praha: Europrint, 2013, 235 s. ISBN 978-80-260-4244-0.

Povinná:

U.S. Department of Health and Human Services

Food and Drug Administration. Guidance for industry: Bioanalytical method validation . 2013, s., §, odst. , .

European Medicines Agency. Guideline on bioanalytical method validation; . 2011, s., §, odst. , .

Doporučená:

Web of Knowledge [online]. Dostupné z: http://webofknowledge.com

Doporučená:

Harvey, David. Modern analytical chemistry. Boston: McGraw-Hill, 2000, 798 s. ISBN 0-07-237547-7.

Requirements to the exam -

Last update: prof. RNDr. Dalibor Šatínský, Ph.D. (01.03.2018)

Main goals in bioanalytical method development

Method development procedure (analyte and sample properties, choice of separation technique and detection method, optimization of conditions as MP, SP etc., selection of sample preparation procedure, final optimization)

Bioanalytical method validation, validation protocol, validation parameters, validation types

Bioanalytical methods validation guidelines

New methods development for clinical studies