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Pharmaceutical Analysis - GDFASDZ1

Title:	SDZ-Farmaceutická analýza
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, STEX [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. PharmDr. Hana Sklenářová, Ph.D.

Examination dates WS schedule SS schedule

Annotation -

Last update: doc. PharmDr. Hana Sklenářová, Ph.D. (11.02.2019)

The main aim of the state doctoral exam is to prove detailed knowledge in the field of Pharmaceutical analysis, including practical aspects of application of instrumental techniques for pharmacopoeial and bio-analytical evaluation of content of biologically active substances in raw materials, drug formulations and biological material (including sample preparation using different extraction procedures).

Literature - Czech

Last update: doc. PharmDr. Hana Sklenářová, Ph.D. (06.03.2019)

Doporučená:

Klimeš, Jiří. Kontrolně-analytické hodnocení léčiv lékopisnými metodami. Hradec Králové: NECLEUS HK, 2011, 265 s. ISBN 978-80-87009-29-1.

Hansen, Steen, Pedersen-Bjergaard, Stig Rasmussen, Knut. Chemical analysis in pharmaceutical sciences. Chichester, West Sussex: John Wiley & Sons Inc., 2012, 494 s. ISBN 978-0-470-66122-2.

Ministerstvo zdravotnictví České republiky. ČL 2017. Praha: Grada, 2017, 6357 s. ISBN 978-80-271-0500-7.

Requirements to the exam -

Last update: doc. PharmDr. Hana Sklenářová, Ph.D. (06.03.2019)

Requirements for state doctoral exam are listed in detail in the following areas:

1. The identity of drugs based on physical constants, using physicochemical methods and chemical reactions.
2. Purity of drugs, evaluation of impurities by chemical reactions and instrumental methods.
3. Chiral purity of drugs, methods for evaluation.
4. Use of spectral methods in pharmaceutical analysis.
5. Use of mass spectrometry in pharmaceutical analysis.
6. Methods for the quantitative evaluation of substances and pharmacetuical formulations.
7. Separation analytical methods used for the analysis of drugs and pharmaceutical formulations.
8. Development and validation of the analytical method for the evaluation of drugs and pharmacetuical formulations.
9. Stability of drugs and pharmaceutcial formulations, factors affecting stability, kinetic characteristics of decomposition reactions, stability tests.
10. Trends in instrumental analytical methods applied in pharmaceutical analysis.
11. Techniques of sample preparation before analysis of biological material, modern and conventional approach, perspectives of their use in pharmaceutical analysis.
12. Analysis of drugs and endogenous substances in biological material.
13. Instrumental analytical and immunoassay methods in drug analysis.
14. Pharmaceutical analysis of biopharmaceuticals.
15. Working principles following the rules of Good manufacture praxis and Good laboratory praxis.