Biopharmaceutics

Question 1

What does open-label mean?

Answer 1

Both participants and health care providers know the drug/treatment given

Question 2

What does it mean when a study is randomized?

Answer 2

Participants are randomly selected to be in the experimental group or control group

Question 3

What is a crossover study?

Answer 3

• Subjects receive a sequence of different treatments
• Most of the time each subject receives all of the tx
• Prefer this to be randomized
• All subjects are both control and test subjects

Question 4

What does it mean when a study is “repeated measures design”?

Answer 4

The same measures are collected multiple times for each subject

Question 5

For 2nd gen intranasal corticosteroids, what percent deposits in the nose?

Answer 5

• 30% deposits in nose and binds w/ glucocorticoid receptor

- Remaining 70% swallowed and subject to first-pass hepatic metabolism

Question 6

What should be noted if a study only has 6 participants?

Answer 6

That is a low number, so the results may not be valuable

Question 7

Why would 2 concentrations of the same drug be tested?

Answer 7

To evaluate impact of dosing volume/amount and concentration

Question 8

Why does the IM route have less bioavailability than the IV route?

Answer 8

• Still needs to be absorbed into bloodstream
• Blood flow will be a factor
• Takes time, which allows for metabolism and excretion

Question 9

Is it bad when a study is open-label?

Answer 9

• Always want to try to make it blind if possible

- Can do a double dummy study

Question 10

What can be done if a drug given intranasally is showing a second peak in their concentration vs. time graph?

Answer 10

• Second peak means there is some GI absorption

- Can give activated charcoal (if drug is susceptible) to adsorb the drug; this will get rid of second peak

Question 11

What is a possible advantage to rectal administration?

Answer 11

1/3 will go through first pass metabolism and remaining 2/3 will go directly to systemic absorption

Question 12

What is used to sterilize microparticles?

Answer 12

Gamma radiation

Question 13

Do you want an equal mix of each gender for a good study?

Answer 13

Yes, unless drug is only relevant to one gender (ex: birth control only for women)

Question 14

Do you want a large age range for a good study? Why?

Answer 14

Yes, b/c PK parameters change as you age

Question 15

What is the difference between a suspension, aerosol, and an emulsion?

Answer 15

• Suspension = solid and liquid
• Aerosol = solid/liquid and air
• Emulsion = liquid and liquid

Question 16

What is a parallel study?

Answer 16

Subjects are randomly assigned control or test, and only do the one they are assigned

Question 17

What does a “three-period, three-treatment crossover” study mean?

Answer 17

• The study is testing 3 different treatments (whether different doses or dosage forms)
• Each subject will test each form, so that requires 3 periods
• In each period, randomized amount of subjects will test one of the treatments, and will test the remaining 2 in the following 2 periods

Question 18

Does absorption vary based on the site of IM injection?

Answer 18

Yes, because tissue vascularity differs and whole body fat distribution differs between males and females

Question 19

Rank blood flow in the common sites of IM injection from highest to lowest

Answer 19

Deltoid > vastus lateralis > gluteus maximus

Question 20

What is the ideal population size for a clinical trial?

Answer 20

20-24 volunteers, with equal males and females if possible

Question 21

Why would a subject not be allowed to engage in strenuous activity after receiving an IM injection?

Answer 21

Will affect blood flow to the injection site, which will alter results of study

Question 22

Are blood or urine samples preferred?

Answer 22

Blood

Question 23

Which values are tested for a bioequivalence study? Do you want the values to be the same or different?

Answer 23

• Look at AUC, Cmax, and Tmax

- Want them to be as close as possible

Question 24

What happens when the dose of an oral product must be given in more than one solid form (ex: 2 capsules)?

Answer 24

We would assume that disintegration of both capsules is the same, but that might not be the case, so imposes some form of error

Question 25

What does single blind mean?

Answer 25

Experimenters know what the subjects are receiving, but the subjects don’t know

Question 26

What does double dummy mean for a study?

Answer 26

All patients are given both active drug and placebo in the same period and alternated in subsequent periods

Question 27

What can be concluded if the rectal route produces greater bioavailability than the oral route?

Answer 27

Some first-pass metabolism is avoided w/ rectal route

Question 28

If a meal is provided in a study, what kind of meal will it be and why?

Answer 28

• Meal w/ high calories and high fat
• This will have the greatest effect on absorption of the drug, so supplying px w/ this meal is assessing bioavailability in the “worst case scenario”

Question 29

Is the product w/ the lower bioavailability always the worse one?

Answer 29

• If want the drug to be absorbed systemically, then you want a higher bioavailability
• Lower bioavailability = less systemic absorption

Question 30

Would you expect a cream or a suppository to have better absorption? Why?

Answer 30

• Drug is already in solution in a cream, but must disintegrate from a suppository
• Would expect cream to have better absorption