Introduction to Biopharmaceutics & Pharmacokinetics

Question 1

active ingredients

Answer 1

drug

Question 2

AI + excipients

Answer 2

drug product

Question 3

interrelationship of physicochemical properties of the drug, the dosage form (drug product) in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption.

Answer 3

biopharmaceutics

Question 4

study of liberation process (release of drug from the drug product). rate & extent of systemic absorption of the therapeutically active drug. the systemic availability of the drug

Answer 4

bioavailability

Question 5

if drug is therapeutically active, what factor?

Answer 5

nature of drug molecule

Question 6

if drug is toxic, what factor?

Answer 6

Route of delivery (liberation process)

Question 7

if drug has no apparent effect, what factor?

Answer 7

Formulation of Dosage form

Question 8

The time course of drug movement in the body during absorption, distribution, metabolism, & excretion (ADME). body –> drug

Answer 8

pharmacokinetics

Question 9

Any drug can be a poison in any dose (T/F)

Answer 9

T

Question 10

metabolism + excretion

Answer 10

elimination

Question 11

Harmful or undesirable effects (possible response).

Answer 11

toxicologic effect

Question 12

Relation of the drug concentration or amount at the site of action (receptor) & its pharmacologic response. Includes biochemical and physiological effects that influence the interaction of a drug with a receptor. drug –> body.

Answer 12

pharmacodynamics

Question 13

component of a cell or organism that interacts with a drug and initiates the chain of events leading to the drug’s observed effects

Answer 13

receptor

Question 14

Drugs that occupy receptors and activate them.

Answer 14

agonist

Question 15

Drugs that occupy receptors but do not activate them.

Answer 15

antagonist

Question 16

Refers to dose and various measures of acute or integrated drug concentrations in plasma and other biological fluid.

Answer 16

drug exposure

Question 17

Refers to direct measure of the pharmacologic effect of the drug. measurable, includes endpoints or biomarkers

Answer 17

drug response

Question 18

Biopharmaceutics involves factors that influence:

Answer 18

-Design of drug product
-Stability of the drug within the drug product
-Manufacture of drug product
-Release of drug from drug product
-Rate of dissolution/release of drug from absorption site
-Delivery of drug to the site of action

Question 19

scope of biopharmaceutics

Answer 19

1. All possible effects observed following the administration of the drug in its various dosage forms
   -therapeutic effect, adverse effect, drug-drug interaction
2. All possible effects of various dosage forms on biological response
   -Onset of action, Duration of action

Question 20

reflects the minimum concentration of drug needed at the receptors to produce the desired pharmacologic effect

Answer 20

MEC (minimum effective concentration)

Question 21

represents the drug concentration needed to just barely produce a toxic effect

Answer 21

MTC (minimum toxic concentration)

Question 22

the concentration between MTC and MEC

Answer 22

Therapeutic window

Question 23

Mas safe yung drug na may narrow na therapeutic window (T/F)

Answer 23

F

Question 24

ratio between toxic and therapeutic dose

Answer 24

Therapeutic index

Question 25

corresponds to the time required for the drug to reach the MEC. drug response is observed

Answer 25

onset time

Question 26

The ______ of the pharmacologic effect is proportional to the number of drug receptors occupied, which is reflected in the observation that higher plasma drug concentrations produce a greater pharmacologic response, up to a maximum. height of the curve

Answer 26

intensity

Question 27

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

Answer 27

duration of drug

Question 28

the time of maximum drug concentration in the plasma and is a rough marker of average rate of drug absorption

Answer 28

time of peak plasma level

Question 29

related to the dose, the rate constant for absorption, and the elimination constant of the drug

Answer 29

peak plasma level or maximum drug concentration

Question 30

related to the amount of drug absorbed systemically. area of the curve

Answer 30

AUC = bioavailability

Question 31

concentration of plasma/ unit time

Answer 31

plasma drug concentration-time curve

Question 32

plasma drug conc-time curve is never linear (T/F)

Answer 32

T

Question 33

bioavailability can be measured by AUC, conc-time curve, drug exposure, and drug response (T/F)

Answer 33

T

Question 34

All possible physiological factors which may affect the drug contained in the dosage form (pH of the stomach & intestine, surface area of skin) (T/F)

Answer 34

T

Question 35

A drug that is bioavailable is less likely to cause an effect in the body.

Answer 35

F (more likely)

Question 36

Application of pharmacokinetic models to drug therapy

Answer 36

clinical pharmacokinetics

Question 37

Factors affecting drug disposition:

Answer 37

Drug disposition serves as basis of dosing regimens Disease Age Gender Genetic and ethnic differences

Question 38

therapeutic drug monitoring (TDM)

Answer 38

very potent drugs ex. w/ narrow therapeutic range; optimize efficacy and prevent adverse toxicity

Question 39

drug concentrations

Answer 39

toxic potentially toxic therapeutic potentially subtherapeutic subtherapeutic

Question 40

goal of pharmaceutic factors affecting drug bioavailability

Answer 40

design a drug product that will deliver active drug in the most bioavailable form

Question 41

physicochemical properties

Answer 41

-Measurable characteristics -Determined by the number, kind, arrangement of atoms -Preferred expression of the properties that relate to biological action vs physical or chemical Ex. pH, solubility, H-bonding, partition coefficient, hydrophilicity, lipophilicity, BBB, placental barrier

Question 42

physicochemical factors that may alter bioavailability

Answer 42

1. particle size of drug in solid dosage form 2. particle size of dispersed phase in an emulsion 3. tablet disintegration 4. tablet and capsule adjuncts 5. tablet coating 6. crystalline drug properties