what is the major site for drug absorption
small intestine
transport is saturated at __
high drug concentration
name 6 physiological factors that affect oral absorption
pka, solubility, charge, partition coefficient, drug-drug interactions, stability
true or false: formulation factors can affect drug release from a drug product
true
name the four primary systems that affect the first pass effect of a drug
enzymes of the gastrointestinal lumen, gut wall enzymes, bacterial enzymes, hepatic enzymes
the rate and extent to which the active ingredient or active moiety is absorbed form a drug product and becomes available at the site of action is the definition of
bioavailability
AUC reflects the __ of absorption
extent
C max and T max reflect the __ of absorption
rate
the fraction of the dose that actually reaches the systemic circulation is the definition of
absolute bioavailability F
for drugs after IV administration F is
equal to one
for drugs after oral administration F is
less than or equal to one
why is bioavailability important to pharmacists
to advise patients on how to correctly take medications to achieve optimal therapeutic effects
the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar do
bioequivalence
drug products that contain the same active drug ingredient and are identical in strength or concentration, dosage form, and route of administration are ___
pharmaceutical equivalents
drug products that contain the same therapeutic moiety but as different salts, esters, or complexes are ___
pharmaceutical alternatives
drug products that contain the same therapeutically active drug that should give the same therapeutic effect and have equal potential for adverse effects under conditions set forth in the labels of these drugs are ___
therapeutic equivalents
biosimilars are derived from
living organisms
name two statistical tests to evaluate data
ANOVA and power test
in the power test the power should be __ or greater than __ and a level of sifnificance of ___
0.8, beta = 0.2, 0.05
generic drug products must be ___ with the brand-name drug product
bioequivalent
a drug is highly soluble if the highest dose strength is soluble in ___ or less of aqueous media over the pH range of ___
250 ml , 1-8
BCS class 1 ___ solubility and ___ permeability
high, high
BCS class 2 __ solubility and ___ permeability
low, high
BCS class 3 ___ solubility and ___ permeability
high, low
BCS class 4 ___ solubility and ___ permeability
low, low
in BCS class 3 drugs bioavailability may be incomplete if the drug is not what
released and dissolved within the absorption window
in BCS class 2 drugs bioavailability is controlled by the what
dosage form and rate of drug released from the drug product