Lecture 9

Question 1

Bioavailability

Answer 1

• FDA : The rate and extent to which an active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.
• American Pharmaceutical Association (APA) : The relative amount of an administered dose that reaches the general circulation and the rate at which this occurs.

Question 2

pharmaceutically equivalent drug

Answer 2

1. In the same dose strength
2. And same dosage form
3. Given by the same route of administration

Question 3

Methods of Assessment

Answer 3

• Plasma drug concentration
• Urinary drug excretion
• Acute pharmacodynamic effect
• Clinical observations
• In vitro studies

Question 4

Plasma drug concentration:

Answer 4

Time for peak plasma (blood) concentration, t max

Peak plasma drug concentration C max

Area under the plasma drug concentration–time curve (AUC)

Question 5

Urinary drug excretion

Answer 5

Cumulative amount of drug excreted in the urine (xu)

Rate of drug excretion in the urine (dXu/dt)

Time for maximum urinary excretion rate (t)

Question 6

Acute pharmacodynamic effect:

Answer 6

Maximum pharmacodynamic effect (Emax)

Time for maximum pharmacodynamic effect

Area under the pharmacodynamic effect—time curve

Onset time for pharmacodynamic effect

Question 7

FDA limits for Bioequivalence

Answer 7

For drugs to be approved as

bioequivalent the 90% confidence

interval for the ratio of medians AUC

and Cmax of should fall within the FDA

limits of 0.80-1.25 (80%-125%).

Question 8

Generic drug manufacturer files an _______ instead of NDA

Answer 8

ANDA

Question 9

For generic drug manufacturer, the bioequivalence study is the pivotal study in ANDA and replaces______________.

Answer 9

animal, clinical and pharmacokinetic studies.

Question 10

The three major factors that governs the rate and extent of drug absorption are:

Answer 10

1. Solubility
2. Permeability
3. Dissolution

Question 11

Pharmaceutical Alternative

Answer 11

• Drug products contain the same therapeutic moiety but differ in salt or ester.
• Or controlled release vs conventional formulation of the same active ingredien

Question 12

Pharmaceutical or Chemical equivalent

Answer 12

• Two drug products that contain equal amounts of the same therapeutically active ingredient in identical dosage forms meet the requirements established by United States Pharmacopeia and or National Formulary
• Such requirements are:
  
  • • Purity.
  • • Content uniformity.
  • • Disintegration time.

Question 13

Therapeutically equivalent

Answer 13

When two or more chemically or pharmaceutically equivalent products when administered in an identical dosage regimen produce the same efficacy and or toxicity in the same individual.

Question 14

the generic drug manufacturer must demonstrate that the generic drug product is _____________________ to the comparator brand-name drug product.

Answer 14

pharmaceutically equivalent, bioequivalent, and therapeutically equivalent