the pharmacokinetic parameters of domestic and imported ranitidine hydrochloride tablets (ranitidine, formulated and manufactured by kharazmi pharmaceuticals, iran, and zantac ? manufactured by glaxo, uk) were measured in 14 healthy subjects following oral administration of a single 300-mg dose of each brand and compared for bioequivalence evaluation. the pharmaceutical equivalency of both form...

BACKGROUND A unique semiautomated border detection program (BDP) designed for use on a personal computer was evaluated to determine whether: (1) carotid intima-media thickness (CIMT) measurements were bioequivalent to a reference laboratory; and (2) it would allow a novice (NOV) reader with no medical training to accurately and reproducibly measure CIMT. METHODS Far-wall CIMT was measured bli...

When an innovative (brand-name) drug is going off patent protection, the innovative drug companies and/or generic drug companies may file an abbreviated new drug application (ANDA) for generic approval through the conduct of a bioequivalence study. Bioequivalence testing for generic approval is based on the Fundamental Bioequivalence Assumption that when two drug products have similar drug abso...

The WHO biowaiver procedure for BCS Class II weak acids was evaluated by running two multisource IR ibuprofen drug products (Ibuprofen, 200 mg tablets, Tatchempharmpreparaty, Russia and Ibuprofen, 200 mg tablets, Biosintez, Russia) with current Marketing Authorizations (i.e. in vivo bioequivalent) through that procedure. Risks associated with excipients interaction and therapeutic index were co...

Introduction. As a part of the registration drug product bioequivalence study fixed-dose combination "Ezetimibe + rosuvastatin" (JSC "Sanofi-aventis group", Russia) compared with coadministered Ezetrol® (ezetimibe) and Crestor® (rosuvastatin) was conducted 76 healthy volunteers. Enzymatic hydrolysis used to evaluate pharmacokinetics total ezetimibe. This reason for inclusion additional monitore...

In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications...