SubjectsSubjects(version: 945)
Course, academic year 2023/2024
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Advanced Pharmaceutical Analysis - GAF350
Title: Advanced Pharmaceutical Analysis
Guaranteed by: Department of Pharmaceutical Chemistry and Pharmaceutical Analysis (16-16190)
Faculty: Faculty of Pharmacy in Hradec Králové
Actual: from 2022
Semester: summer
Points: 0
E-Credits: 4
Examination process: summer s.:written
Hours per week, examination: summer s.:14/28, C+Ex [HS]
Capacity: unknown / unknown (unknown)
Min. number of students: unlimited
4EU+: no
Virtual mobility / capacity: no
Key competences:  
State of the course: not taught
Language: English
Teaching methods: full-time
Teaching methods: full-time
Level:  
Guarantor: doc. PharmDr. Radim Kučera, Ph.D.
Pre-requisite : GAF306
In complex pre-requisite: GAF1001
Examination dates   Schedule   
Annotation -
Last update: doc. PharmDr. Radim Kučera, Ph.D. (15.01.2018)
The issue of ensuring the quality and safety of medicines is a topical task of modern pharmacy worldwide. Pharmaceutical analysis (FA) addresses this area. The attention in the subjects Pharmaceutical Analysis I and II is mainly focused on the pharmacopoeial analysis and analytical evaluation of drugs, especially according to Czech and European Pharmacopoeia. Subject Advanced Pharmacy Analysis (AFA) follows the theoretical and practical teaching of above-mentioned subjects and offers the students a broadening of knowledge in the field of pharmaceutico-analytical and bioanalytical evaluation of drugs, including familiarization with modern trends in these fields. One of the aims of the PFA course is to bring students closer to the activities aimed at ensuring the quality and safety of medicines in the pharmaceutical industry. This topic will be presented by practitioners who professionally deal with quality control and quality assurance. Teaching will focus not only on theory but also on practical skills.
Course completion requirements -
Last update: doc. PharmDr. Radim Kučera, Ph.D. (15.01.2018)

Credit Requirements

1.     Presence at all seminars and practical trainings

2.     Approved reports from all practical tasks

 

Exam

Literature -
Last update: doc. PharmDr. Radim Kučera, Ph.D. (15.01.2018)

Obligatory:

  • Hansen, Steen Pedersen-Bjergaard, Stig Rasmussen, Knut. Introduction to pharmaceutical chemical analysis. Chichester: Wiley, 2012, 494 s. ISBN 978-0-470-66122-2.
  • Kazakevich, Yuri LoBrutto, Rosario (eds.). HPLC for pharmaceutical scientists. Hoboken, N.J.: Wiley-Interscience, 2007, 1104 s. ISBN 978-0-471-68162-5.

Syllabus -
Last update: doc. PharmDr. Radim Kučera, Ph.D. (15.01.2018)

Lectures and seminars

  • The role of international and national regulatory authorities in ensuring the quality and safety of pharmaceuticals.

  • Registration of drugs from the viewpoint of pharmaceutical analysis.

  • Good Manufacturing Practice (GMP) in Pharmaceutical industry and analytical laboratory.

  • Tasks and activities of the Quality Control (QC), Quality Assurance (QA) in pharmaceutical industry.

  • The role and activities of a Qualified Person (QP) at the release of drug batches.

  • Analytical evaluation of biological drugs.

  • Stationary phases used in separation methods and trends in their development.

  • Solid-state pharmaceutical analysis (NMR, X-ray diffraction, DSC, TGA).

  • Modern trends in Pharmaceutical analysis (SFC, sensors, bio-pharmaceuticals)

  • Bioequivalence studies.

  • Mass spectrometry in pharmaceutical analysis.

Practical training

  • Tests for the purity of pharmaceuticals and pharmaceutical excipients using AAS.

  • Pharmacopoeial evaluation of purified water quality using TOC.

  • HPLC / UHPLC Method transfer for evaluation of medicinal products.

  • The use of head-space gas chromatography in the analysis of drugs and biologically active substances.

  • Quantification and identification of drugs and their metabolites using LC/MS.

Teaching methods -
Last update: doc. PharmDr. Radim Kučera, Ph.D. (15.01.2018)

Lectures, seminars, practical trainings

 
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