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Vojnosanitetski pregled
2007, vol. 64, br. 4, str. 265-270
jezik rada: srpski
vrsta rada: saopštenje
doi:10.2298/VSP0704265I
Farmakovigilanca u kliničkim istraživanjima
Univerzitet u Beogradu, Farmaceutski fakultet, Institut za farmakologiju

e-adresa: kettyilic@hotmail.com

Sažetak

Spontano saopštavanje o neželjenim efektima lekova u postregistracionoj fazi je od značaja za registrovanje retkih neželjenih efekata. Međutim, kliničke studije omogućavaju da se pouzdano utvrdi učestalost neželjenih efekata, kao i da se proceni da li je toksični potencijal leka takav da može omogućiti njegovu bezbednu primenu. Neophodno je da se farmakovigilanca detaljno planira, sistematski sprovodi i da ima podjednako važnu ulogu u kliničkim istraživanjima, kao utvrđivanje efikasnosti leka. Objavljivanju rezultata kliničkih istraživanja koji se odnose na neželjena dejstva lekova treba posvetiti veću pažnju. Regulatorne agencije moraju usloviti sponzore i istraživače da putem naučnih publikacija što pre učine dostupnim široj naučnoj javnosti podatke koji se odnose na toksičnost leka. Ovo je najbolji način da se na vreme, tj. pre registracije leka, proceni da li je korist veća od eventualne štete koju može imati njegova primena.

Ključne reči

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