Předmět WHO/EU Labor. and Regul. Procedures (UCH / 773)

Na serveru studentino.cz naleznete nejrůznější studijní materiály: zápisky z přednášek nebo cvičení, vzorové testy, seminární práce, domácí úkoly a další z předmětu UCH / 773 - WHO/EU Labor. and Regul. Procedures, Přírodovědecká fakulta, Jihočeská univerzita v Českých Budějovicích (JU).

Materiál	Typ	Datum	Počet stažení

Obsah

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.

Literatura

C. H. Dempsy: Laboratory Accreditation and Data Certification, CRC press. Guidance on genotoxicity testing, ich 2011. duration of chronic toxicity testing in animals, s4, ich 1998. Harmonized guidelines for single laboratory validation of methods of analysis (iupac technical report), pure appl. chem., vol. 74, no. 5, pp. 835-855, 2002. http://clinicaltrials.gov/ct2/info/understand. Impurities in new drug substances q3a(r2), ich 2006. Residual solvents, ich q3c, 1997. Stability testing of new drug substances and products q1a(r2), ich 2003. Testing for carcinogenicity of pharmaceuticals s1b, ich 1997. 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.

Garant

RNDr. Alexandr Jegorov, CSc.

Vyučující

RNDr. Alexandr Jegorov, CSc.