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  • Clinical development of new indications of SSRI's : the contribution of research-based pharmaceutical companies = Klinično preizkušanje novih terapevtskih indikacij za inhibitorje privzema serotonina : prispevek inovativnih farmacevtskih družb
    Migom, Chris
    Companies have to rely on a limited number of highly successful products to finance the cost of research and development. Obtaining approval or registration of a new drug really encompasses two ... aspects: first the technicaland manufacturing approval of the molecule in it is commercial form, together with the packaging material. Second and most important the proof and documentation of safety and efficacy. The true difference between a molecule and a drug is an as optimal as possible safety/efficacy ratio, reflected in the Summary of Product Characteristics and the Patient Information Leaflet. The inspiration for many new indications frequently comes from astute clinicalobservation but ultimately needs confirmation through rigourously designed and performed clinical trials. Because of the safety limitations of the tricyclic antidepressants and the burgeoning psychopharmacological knowledge base, more specifically the importance of the serotonine receptor, the Selective Serotonine Reuptake Inhibitors or SSRIs were developed on a ration basis. This involved a "top down" approach, with the logic being to eliminate the side-effects of the TCAs by eliminating blockade of the muscarinic, cholinergic, H1-histaminergic and alpha-1-adrenergic receptors andin addition, eliminating noradrenaline reuptake properties. The article presents international experience in developing several indications of the SSRI drugs.
    Vir: Farmacevtski vestnik : strokovno glasilo slovenske farmacije = pharmaceutical journal of Slovenia. - ISSN 0014-8229 (Letn. 51, pos. št., maj 2000, str. 223-228)
    Vrsta gradiva - članek, sestavni del
    Leto - 2000
    Jezik - angleški
    COBISS.SI-ID - 11839705

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