PHA 326: Intro to Biopharmaceutics

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1

Finished dosage form (i.e. tablet/solution) that contains a drug substance, generally, but not necessarily in association w/ one or more ingredients

Drug Product

2

Active ingredient intended to furnish pharmacological activity / other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease.

Drug substance

3

Movement of the drug form the site of administration into the blood

Drug absorption

4

The rate and extent to which the AI / active moiety is absorbed from a drug product and becomes available at the site of drug action

Bioavailability

5

Biopharmaceutics is the science that examines the interrelationship b/w the:

  • Physical and chemical properties of a drug
  • Pathology and normal physiology of the patient
  • Dosage form in which the drug is given
  • Route by which the dosage form is administered on the bioavailability
6

Determining what type of effect you want a drug to have (i.e. rapid effect, prolonged effect, freq. of administration, local action) is known as _______________

Therapeutic objective

7

What are some biopharmaceutic considerations in drug product design?

  • Therapeutic objective
  • API
  • Route of admin
  • Dosage and regimen
  • Type of product
  • Excipients
  • Manufacturing method
8

Does a drug have to be in solution to be absorbed?

Yes

9

In ________ the drug is eliminated unchanged

Excretion

10

In __________ the drug undergoes a chemical change within the body

Metabolism

11

Following extravascular administration, ___________ must occur for a systemic effect from the drug.

Absorption

12

Why are drug concentrations more often measured in plasma rather than whole blood/serum?

  • Whole blood has other stuff in it that could affect the measurements
  • Seurm still has proteins in it
  • Plasma is easier to collect
13

MEC

Minimum effective concentration

14

MTC

Minimum toxic concentration

15

Time when therapeutic response is first observed

Onset time

16

Time that drug remains above MEC

Duration

17

Related to the number of receptors with which drug interacts

Intensity

18

What happens to Cmax, AUC, and tmax when the amount absorbed increases?

  • Cmax and AUC increase
  • tmax stays the same
19

What happens to Cmax, AUC, and tmax when the rate absorbed increases?

  • Cmax and tmax increase
  • AUC stays the same
20

How are plasma level vs. time curve parameters determined for Cmax and tmax ?

Graph data and visually pull data off graph

21

How are plasma level vs. time curve parameters determined for AUC?

Trapezoidal rule

22

True/False: It would be best if MEC and MTC were close together.

False

23

Trapezoidal Rule:

Area = 1/2 (a+b)*c