Naslov
True and false on generic drugs – scientific approach

Autori
Meštrović, Ernest

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Knjiga sažetaka, Farmaceutski forum Jugoistočne Europe / - , 2015, 10-10

Skup
Farmaceutski forum Jugoistočne Europe

Mjesto i datum
Poreč, Hrvatska, 23.11.2015

Vrsta sudjelovanja
Pozvano predavanje

Vrsta recenzije
Domaća recenzija

Ključne riječi
generic drug ; inventive crystalline forms ; Hatch-Waxman amendments
(generic drug ; inventive crystalline forms ; Hatch-Waxman amendments ;)

Sažetak
The development of medicines is an elaborative task that demands a great deal of time and expertise in a broad range of physical and medicinal sciences. Also, once when product reaches the market, there is constant activity to study influence on patients, as well contribution to improve health. Because of significant investment which is connect with research and development of new drug there is many patent which protect intellectual property of the company which invest in drug research and development. When some of patent expire there is option for another company to enter to the market. The expiration of the patent and entering another company on the drug market with specific molecule is connect with term “generic drug”. Under name of “generic” there is many scenario how one company can enter to the market. There is also option that on the same time company will bring product on the market which is “generic” by definition of: A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics, and intended use but on same time innovative by methods of preparation, administration or with inventive crystalline forms. For this scenario which is in US define by Hatch-Waxman amendments extensive research and development activity is needed. Performing R&D activity many company bring new invention on existing molecule, which is connect with new synthetic approach for preparation of drug substance (active pharmaceutical ingredeents, API) in discovery of new crystalline forms or invention in formulations. Based on this research activity ther is contribution to increase knowledge about specific molecule, which at the nd is benefit for end customers.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija

POVEZANOST RADA