TY  -  
T1  - Keskeisimmät eroavaisuudet bioekvivalenssitutkimusten viranomaisohjeistoissa : CAT-simulaatiomallinnus bioekvivalenssitutkimusten riskiarviossa 
SN  -  /  
UR  - URN:NBN:fi-fe20180115198; http://hdl.handle.net/10138/17384 
T3  -  
A1  - Heinonen, Susanna 
A2  -  
PB  - Helsingfors universitet 
Y1  - 2010 
LA  - fin 
AB  - Methods for the assessment of the bioequivalence (BE) of drug products are generally well-documented and the approaches for such studies are described in guidances issued by regulatory authorities throughout the world. While in general, the BE requirements of most regulatory bodies have much in common, in various instances specific issues and approaches may differ. In the literature part of the master's thesis these differences in the selected regulatory BE guidelines (Europe, United States and ... 
VO  -  
IS  -  
SP  -  
OP  -  
KW  - bioequivalence; bioequivalence studies; regulatory guidelines; CAT model; risk assessment; bioekvivalenssi; bioekvivalenssitutkimukset; viranomaisohjeistot; CAT-malli; riskiarvio; Biofarmaci; Biopharmacy; Biofarmasia 
N1  -   
PP  -  
ER  -