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Lecturer(s)
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Jegorov Alexandr, RNDr. CSc.
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Course content
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Contents of lectures: 1.Basic definition of products (food, dietary supplements, chemicals, API´s, drugs, etc.). 2.Relevant part of EC, WHO, FAO, FDA, national authority, ets., guidelines, and their mutual relationship. Tracing of a selected example. 3.Registration of products. 4.Test methods - a state of art. Qualitative and quantitative aspects. 5.Review of instrumental methods; principle, availability, cost, and information value. 6.Validation of analytical methods. 7.Testing of biological activity. Ethical guidelines, laboratory screening, models, and approved methods. 8.Origin and importance of impurities. Case examples. Qualification of impurities.
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Learning activities and teaching methods
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Monologic (reading, lecture, briefing), Dialogic (discussion, interview, brainstorming), Demonstration
- Class attendance
- 26 hours per semester
- Preparation for exam
- 20 hours per semester
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Learning outcomes
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In this unique, industry practice-oriented course, students learn laboratory and legal procedures commonly performed by industrial laboratory/research supervisors. The requirements and WHO/EU regulations for registration, testing and authorized analysis of drugs, (bio)chemical products, dietary supplements, food, etc. are given. An important part of this course is a description of practical experience from the laboratories - how to prepare a sample, how to interpret the data etc. We recommend this course to everybody who is planning her/his carrier in the chemical, biotechnological, or pharmaceutical industry or the pharmaceutical (including production or development).
Students will gain knowledge on regulations in the pharmaceutical and chemical industry and research laboratories.
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Prerequisites
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Knowledge of organic, inorganic chemistry, and biochemistry.
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Assessment methods and criteria
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Test
Students must correctly answer at least 50 % of test questions.
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Recommended literature
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C. H. Dempsy: Laboratory Accreditation and Data Certification, CRC press.
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Guidance on genotoxicity testing, ich 2011. duration of chronic toxicity testing in animals, s4, ich 1998.
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Harmonized guidelines for single laboratory validation of methods of analysis (iupac technical report), pure appl. chem., vol. 74, no. 5, pp. 835-855, 2002.
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http://clinicaltrials.gov/ct2/info/understand.
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Impurities in new drug substances q3a(r2), ich 2006.
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Residual solvents, ich q3c, 1997.
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Stability testing of new drug substances and products q1a(r2), ich 2003.
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Testing for carcinogenicity of pharmaceuticals s1b, ich 1997.
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The rules governing medicinal products in the european union, volume 2b presentation and content of the dossier common technical document (ctd), european commission october 2001.
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