Industrijska Farmacija-izpit

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INDUSTRIJSKA FARMACIJA-izpit

24.3.2009

1. Razloži parametre, ki jih mora proizvajalec preučiti in dokazati, da lahko dokaže varnost, učinkovitost in kakovost. 2. Navedite osnovne predformulacijske študije. 3. EDMF: kaj je to, kakšen je njen namen, sestava in vsebina. 4. Kaj lahko v farmacevtski industriji patentiramo, navedite primere, lahko izmišljene. 5. Originarot in generik; definirajte in napišite razlike. 6. Kaj je bistvo validacije, kako bi jo izvedli na novi tabletirki. 7. Razloži kratice PCT, EPO, WIPO, IQ, OQ, PQ.

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