Biopharm Exam 2

The differential equation (dX/dt) is commonly used in pharmacokinetics. What does this term represent? A. Total dose B. Difference between absorption and elimination rates C. Volume of distribution D. Bioavailability

B. Difference between absorption and elimination rates

When modeling drug elimination from the body, which assumption is most commonly applied? A. Zero-order kinetics B. Non-linear kinetics C. First-order kinetics D. Saturable kinetics

C. First-order kinetics

For drugs following first-order elimination, the rate of elimination is proportional to: A. Amount of drug in plasma B. Dose administered C. Ka D. Bioavailability

A. Amount of drug in plasma

If the elimination rate constant (Ke) increases, what happens to Tmax? A. Decreases B. Increases C. No change D. Doubles

A. Decreases

If Ke decreases, what happens to Tmax? A. Decreases B. Becomes zero C. No change D. Increases

D. Increases

Flip-flop kinetics occurs under which condition? A. Ka > Ke B. Ka < Ke C. Ka = Ke D. Ke = 0

B. Ka < Ke

When Ka < Ke, what happens? A. Tmax increases drastically B. AUC increases C. Cmax and AUC decrease D. Elimination stops

C. Cmax and AUC decrease

Flip-flop kinetics is most commonly seen in: A. IV bolus B. Immediate release C. Transdermal D. SR/ER formulations

D. SR/ER formulations

In multiple oral dosing, why are doses given before full elimination? A. Prevent metabolism B. Maintain therapeutic levels C. Increase bioavailability D. Reduce Tmax

B. Maintain therapeutic levels

For multiple IV dosing, which parameter is most important? A. Bioavailability B. Half-life C. Ka D. Tmax

B. Half-life

What is the accumulation factor? A. Ratio of peak levels B. Ratio of AUCs C. Ratio of Ka/Ke D. Ratio of steady-state trough to first-dose trough

D. Ratio of steady-state trough to first-dose trough

When Ka >> Ke, accumulation depends primarily on: A. Dose B. Ka C. Tmax D. Ke

D. Ke

How does single-dose AUC compare to steady-state AUC over one interval? A. Larger B. Equal C. Smaller D. Unrelated

B. Equal

Maintenance dose is based on: A. Cmax B. Cmin C. Average steady-state concentration D. Tmax

C. Average steady-state concentration

Minimum concentration after first dose equals: A. Cmax B. Clearance C. Half-life D. Steady-state trough

D. Steady-state trough

Bioavailability refers to: A. Metabolism B. Distribution C. Extent of absorption into systemic circulation D. Excretion

C. Extent of absorption into systemic circulation

Absolute bioavailability is calculated as: A. AUC_IV/AUC_PO B. Cmax ratio C. AUC_PO/AUC_IV D. Dose ratio

C. AUC_PO/AUC_IV

AUC is proportional to dose when: A. Ka constant B. Ke and Vd constant C. Tmax constant D. Protein binding constant

B. Ke and Vd constant

Cumulative urinary excretion (Du) reflects: A. Distribution B. Metabolism C. Clearance D. Total absorbed drug

D. Total absorbed drug

Relative bioavailability compares: A. IV vs PO B. IM vs IV C. Oral dosage forms vs oral solution D. PO vs transdermal

C. Oral dosage forms vs oral solution

Bioequivalence means: A. Same excipients B. Same packaging C. Same brand D. No significant difference in rate and extent

D. No significant difference in rate and extent

The acceptable 90% CI range is: A. 75–120% B. 70–130% C. 85–115% D. 80–125%

D. 80–125%

Bioequivalence metrics use: A. Arithmetic mean B. Median C. Geometric mean D. Mode

C. Geometric mean

SUPAC refers to: A. Bioequivalence testing B. Drug absorption C. Scale-up and post-approval changes D. Drug metabolism

C. Scale-up and post-approval changes

Brand-name drugs require: A. ANDA B. NDA C. IND D. BLA

B. NDA

Generic drugs require: A. NDA B. IND C. BLA D. ANDA

D. ANDA

Generic drugs may differ in: A. Active ingredient B. Dose C. Therapeutic effect D. Excipients/formulation

D. Excipients/formulation

The Orange Book lists: A. Drug prices B. Clinical trials C. Approved drugs with therapeutic equivalence D. Drug metabolism

C. Approved drugs with therapeutic equivalence

A-rated drugs are: A. Not equivalent B. Experimental C. Therapeutically equivalent D. Withdrawn

C. Therapeutically equivalent

B-rated drugs are: A. Equivalent B. Not therapeutically equivalent C. OTC D. Generic only

B. Not therapeutically equivalent

Sequential conversion refers to: A. PO to IV B. IM to IV C. IV to oral D. Topical to oral

C. IV to oral

ER/SR products include: A. Solutions B. Suspensions, capsules, tablets C. Injections D. Gases

B. Suspensions, capsules, tablets

Delayed-release products include: A. Capsules B. Syrups C. Enteric-coated tablets D. IV drugs

C. Enteric-coated tablets

ER drug release may follow: A. Only zero-order B. Only first-order C. Mixed-order only D. Zero or first-order

D. Zero or first-order

In zero-order release, elimination begins: A. Immediately B. Before absorption C. After Tmax D. After full release

D. After full release

Biphasic tablets contain: A. Only IR B. Only ER C. No drug D. IR + ER

D. IR + ER

Only a few acidic drugs are absorbed in the stomach: A. True B. False C. Only weak acids D. Only strong acids

B. False

Splanchnic circulation receives approximately: A. 10% B. 50% C. 28% D. 75%

C. 28%

Cardiac output after meals: A. Decreases B. Stops C. No change D. Increases

D. Increases

The upper stomach primarily: A. Grinding B. Mixing C. Absorption D. Basal pressure

D. Basal pressure

The lower stomach primarily: A. Storage B. Weak contractions C. Strong mixing/grinding D. Secretion only

C. Strong mixing/grinding

Lower stomach activity is stimulated by: A. pH B. Enzymes C. Temperature D. Distention and calories

D. Distention and calories

Interdigestive contractions are controlled by: A. Hormones B. Blood flow C. Enzymes D. Migrating myoelectric complex

D. Migrating myoelectric complex

Phases I and II are: A. High activity B. Short C. Long low activity D. Absent

C. Long low activity

Phase III is known as: A. Mixing B. Absorption C. Storage D. Housekeeping wave

D. Housekeeping wave

Phases III and IV are: A. Resting B. Absorptive C. Storage D. Discharging

D. Discharging

Double peak phenomenon is seen in: A. IV B. Immediate release C. Extended release D. Topical

C. Extended release

Peristalsis refers to: A. Enzyme activity B. Blood flow C. Metabolism D. Propulsive contractions

D. Propulsive contractions

Absorption window refers to: A. Time of dosing B. Tmax C. Half-life D. GI segment where drug is best absorbed

D. GI segment where drug is best absorbed

Enterohepatic recirculation involves: A. Renal excretion B. Lung metabolism C. Biliary cycling D. Skin absorption

C. Biliary cycling

Drugs are excreted in bile mainly as: A. Proteins B. Lipids C. Sulfates D. Glucuronides

D. Glucuronides

β-glucuronidase: A. Inhibits metabolism B. Converts drug to metabolite C. Stops absorption D. Converts conjugate to parent drug

D. Converts conjugate to parent drug

These drugs are typically: A. Hydrophilic B. Small MW C. Lipophilic high MW D. Ionized

C. Lipophilic high MW