A. FVIII circulated throughout the plasma in an active heterodimer form that suppresses the production of active VWF B. FVIII is non-covalently bound to VWF until vascular damage and bleeding occurs, at which point FVIII disassociates from VWF as a heterotrimer to bind to the activated platelet surfaces C. When administered in persons with hemophilia A (PWHA), FVIII rapidly binds to endogenous VWF D. As concentrations of endogenous VWF antigen increase, the AUC (norm) and half-life of FVIII significantly increases and clearance significantly decreases.

A. Hepatitis A virus (HCV) B. Hepatitis B virus (HBV) C. Hepatitis C virus (HCV) D. Hepatitis E virus (HEV)

A. SPINART B. ESPRIT C. Kids A-LONG D. SIPPET

A. 0.2-0.8 B. 1.0-1.3 C. 1.4-1.6 D. 1.9-2.7

A. Plasma-derived FVIII products are associated with lower rates of inhibitor formation compared with recombinant FVIII products. B. Plasma-derived FVIII products are associated with lower rates of adverse events compared with recombinant products. C. Plasma-derived FVIII products are noninferior to recombinant products for the prophylactic treatment of adult PWHA. D. Plasma-derived FVIII products are noninferior to recombinant products for the prophylactic treatment in terms of inhibitor development.

A. Emicizumab-kxwh B. Efmorotocog alfa C. Rurioctacog alfa pegol D. Turoctocog alfa pegol

A. To capture peak PK occurrences, as these can be difficult to predict B. To capture trough PK occurrences, as these can be difficult to predict C. To capture the timing of any inhibitor development, as this can predict treatment response D. To capture drug decay in vivo, as this parameter can predict short-term bleed risk

A. Age B. Gender C. Blood type D. Genetics

A. Individual PK parameters are compared with PK parameters of other PWHA and the dosing schedule of the individual with the closest matching PK profile is used to inform treatment B. Individual PK parameters are compared with the PK parameters derived from PK studies performed in a large cohort using a Bayesian model so that FVIII can be dosed appropriately C. Individual PK parameters from a large cohort are stored in a database so that mean AUC (norm) and half-life from the cohort can be tracked over time to inform future drug development D. Individual PK parameters are matched with the PK parameters derived from PK studies performed in a large cohort and sorted by age, sex, ethnicity, and weight so that a more individualized dosing strategy can be provided based on those parameters

A. The need for fewer individual drug concentration values (ie, samples) compared with traditional PK studies B. The need for a small, relatively homogenous cohort of samples upon which an individual's PK parameters can be compared C. The ability to take into account both identified covariates that influence PK parameters as well as the unknown modifiers of PK as they are described by the population data within the model D. The potential to effectively reduce the target level of FVIII in some PWHA