BIOPHARMACEUTICS

Question 1

What is Biopharmaceutics?

Answer 1

the study of how the physicochemical properties of drugs, dosage forms and routes of administeration affect the rate and extent of the drug absorption.

Question 2

Biopharmaceutics involves factors that influence the

Answer 2

1) protection and stability of the drug within the product;
2) the rate of drug release from the product;
3) the rate of dissolution of the drug at the absorption site; and
4) the availability of the drug at its site of action .

Question 3

Pharmacokinetics is

Answer 3

The study and characterization of the time course (kinetics) of drug absorption, distribution, metabolism and elimination (ADME).

Question 4

What is Absorption?

Answer 4

Absorption is the process of a substance entering the
body.

Question 5

What is Distribution?

Answer 5

Distribution is the dispersion of substances throughout the fluids and tissues of the body.

Question 6

What is Metabolism?

Answer 6

Metabolism is the irreversible transformation of parent compounds into daughter metabolites.

Question 7

What is Excretion?

Answer 7

Excretion is the elimination of the substances from the body.

Question 8

What is Bioavailability?

Answer 8

Bioavailability is the rate and extent of drug absorption.

Question 9

What is Bioavailable dose?

Answer 9

Bioavailable dose is the fraction of an administered dose of a particular drug that reaches the systemic circulation intact.

Question 10

How is The plasma level-time curve generated?

Answer 10

The plasma level-time curve is generated by measuring the drug concentration in plasma samples taken at various time intervals after a drug product is administered.

Question 11

What are the main Drug Product Performance Parameters?

Answer 11

1. Minimum effective concentration (MEC)
2. Minimum toxic concentration (MTC)
3. Onset time
4. Duration of action
5. The time of peak plasma level
6. The peak plasma level
7. Area under the curve

Question 12

What is Minimum effective concentration (MEC)?

Answer 12

It is the minimum concentration of drug needed at the receptors to produce the desired pharmacologic effect.

Question 13

What is the Minimum toxic concentration (MTC)?

Answer 13

It is the drug concentration needed to just produce a toxic effect.

Question 14

What is the Onset time?

Answer 14

Onset time is the time required for the drug to reach the
MEC.

Question 15

What is the Duration of action?

Answer 15

It is the difference between the onset time and the time for the drug to decline back to the MEC.

Question 16

What is the time of peak plasma level

Answer 16

The time of peak plasma level is the time of
maximum drug concentration in the plasma and
is proportional to the rate of drug absorption.

Question 17

What is the peak plasma level?

Answer 17

The peak plasma level is the maximum drug concentration, usually related to the dose and the rate constants for absorption and elimination of the drug.

Question 18

What is the Area under the curve?

Answer 18

The area under the curve is related to the
amount of drug absorbed systemically.