Bioequivalence Questions With Answers
First order rate constant for absorption (ka)
The bioavailability factor (F) What are the basic parameters that control the rate and
extent of absorption?
total amount of drug in plasma from time of drug administration until its complete elimination
Drug availability in plasma is qualified in terms of what?
The area under the plasma concentration-time curve (AUC) from zero to infinity
The time of the peak plasma concentration (Tmax)
The value of the peak plasma concentration (Cmax) Bioavailability is assessed by
measuring 3 characteristics that define the plasma concentration time curve:
concentration time curve
AUC (AUC alpha F*D) cumulative exposure: proportional to the dose that gets into
systemic circulation
If dose is constant/known, AUC alpha F
Not affected by rate of absorption
Cmax alpha F if F increases, Cmax increases proportionally and vise versa
, Tmax not affected by extent of absorption F
Dependent on rate: if rate increases, Tmax decreases
Cmax The faster the rate, the faster we get to _____
Extent (F) AUC is dependent on ______
Extent and rate Cmax is dependent on _______
rate (ka) Tmax is dependent on ______
absolute bioavailability actual value of F determined by comparing AUC from PO to AUC
from IV
Fpo = (AUC/unit dose PO)/(AUC/unit dose IV) Absolute bioavailabilty equation
relative bioavailabiltiy the bioavailability of an extravascular route compared to an
established standard
An oral solution, which usually has the highest bioavailability of oral dosage forms
A standard dosage form Examples of standards: