Avtor/Urednik		Rotar, Aleš; Rustja, Eli
Naslov		Razvoj generičnih zdravil v Krki
Prevedeni naslov		Development of generic pharmaceuticals at Krka
Tip		članek
Vir		Zdrav Vestn
Vol. in št.		Letnik 66, št. Suppl 2
Leto izdaje		1997
Obseg		str. II-33-6
Jezik		slo
Abstrakt		The last decade was marked by significant changes in the pharmaceutical industry as a result of developments of health-care market. Significant growth of generic pharmaceutical industry is one of the most significant elements of change. Generic product or process is not protected by a patent and as a result it is a public domain. There are significant differences among generic pharmaceutical companies. Research and development is the area to which companies dedicate different levels of expertise as well as resources. The result of the development process in pharmaceutical industry is the product supported by sophisticated documentation. The latter is used to overcome three clusters of entry barriers: patients, registration and quality assurance. The development process at Krka is carried out at the level of complexity defined by the latest international requirements. Knowledge and teamwork ability determine the final result of the development process in terms of both the product and the documentation. At least eight scientific disciplines ranging from chemistry and pharmacy to medicine and biology have to be covered successfully. The starting point represents the active substance which is developed and manufactured at Krka in case of strategic products. The key to successful development is facts based decision making which requires excellent analytical methodology. Pharmaceutical dosage forms are developed by interaction studies as well as by optimisation of the method of manufacturing. In the last stages of development the product is evaluated: first in vivo bioavailability and stability are assessed. After the positive results are confirmed in vitro experiments which comprise pharmacokinetic and clinical studies (an exception for generic companies) are carried out. (Abstract truncated at 2000 characters).
Izvleček		V zadnjih letih je prišlo v farmacevtski industriji do velikih pretresov, ki so posledica razvoja trga zdravstvenih storitev ter proizvodov. Prodor industrije generičnih zdravil je eden od pomembnih elementov v tem razvoju. Generičen je vsak izdelek ali postopek za njegovo izdelavo, za katerega ne obstaja patentna zaščita in je torej javna domena. V segmentu generičnih zdravil obstajajo bistvene razlike v obsegu in kakovosti razvojno raziskovalnega dela, ki ga posamezna podjetja izvajajo v fazi razvoja novega zdravila. Rezultat razvojnega dela je poleg samega pripravka obširna dokumentacija, ki mora pokrivati tri poglavitne vstopne bariere za posamezne trge. To so: industrijska lastnina, registracija zdravil in zagotvljanje kakovosti. V Krki pokrivamo vse tri sklope in sicer tako, da razvoj novega izdelka spremlja priprava dokumentacije v skladu z normami najzahtevnejših ciljnih trgov. Kakovost razvojnega dela in raven dokumentacije sta odvisna od znanja in sposobnosti skupinskega dela. Razvoj novega zdravila zahteva obvladovanje najmanj osmih področij naravoslovnih in biomedicinskih znanosti. Izhodišče predstavlja učinkovina, ki jo v primeru strateško pomembnih preparatov razvijamo in izdelujemo v Krki. Pomemben korak je priprava ustreznih analiznih orodij, saj je le eksaktno vrednotenje eksperimentalnih rezultatov ustrezna podlaga za uspešen razvojni projekt. Razvoj zdravilne oblike temelji na študijah interakcij in optimizaciji procesa izdelave. Pri tem so odločilnega pomena štirje sklopi vrednotenja: najprej in vitro eksperimenti biorazpoložljivosti in študije stabilnosti. V zadnjih dveh fazah izvajamo farmakokinetske in kot ena redkih generičnih firm tudi klinične študije. V zadnjih letih se povsod po svetu, zlasti pa v centralni in Evropi zakonodaja, ki ureja registracijo zdravil ter zagotavljanje kakovosti skokovito spreminja. (Abstract truncated at 2000 characters).
Deskriptorji		DRUG DESIGN DRUG APPROVAL DRUGS, GENERIC DRUG COSTS CLINICAL TRIALS DRUG EVALUATION