What does open-label mean?
Both participants and health care providers know the drug/treatment given
What does it mean when a study is randomized?
Participants are randomly selected to be in the experimental group or control group
What is a crossover study?
- 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
What does it mean when a study is “repeated measures design”?
The same measures are collected multiple times for each subject
For 2nd gen intranasal corticosteroids, what percent deposits in the nose?
- 30% deposits in nose and binds w/ glucocorticoid receptor
- Remaining 70% swallowed and subject to first-pass hepatic metabolism
What should be noted if a study only has 6 participants?
That is a low number, so the results may not be valuable
Why would 2 concentrations of the same drug be tested?
To evaluate impact of dosing volume/amount and concentration
Why does the IM route have less bioavailability than the IV route?
- Still needs to be absorbed into bloodstream
- Blood flow will be a factor
- Takes time, which allows for metabolism and excretion
Is it bad when a study is open-label?
- Always want to try to make it blind if possible
- Can do a double dummy study
What can be done if a drug given intranasally is showing a second peak in their concentration vs. time graph?
- 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
What is a possible advantage to rectal administration?
1/3 will go through first pass metabolism and remaining 2/3 will go directly to systemic absorption
What is used to sterilize microparticles?
Gamma radiation
Do you want an equal mix of each gender for a good study?
Yes, unless drug is only relevant to one gender (ex: birth control only for women)
Do you want a large age range for a good study? Why?
Yes, b/c PK parameters change as you age
What is the difference between a suspension, aerosol, and an emulsion?
- Suspension = solid and liquid
- Aerosol = solid/liquid and air
- Emulsion = liquid and liquid
What is a parallel study?
Subjects are randomly assigned control or test, and only do the one they are assigned
What does a “three-period, three-treatment crossover” study mean?
- 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
Does absorption vary based on the site of IM injection?
Yes, because tissue vascularity differs and whole body fat distribution differs between males and females
Rank blood flow in the common sites of IM injection from highest to lowest
Deltoid > vastus lateralis > gluteus maximus
What is the ideal population size for a clinical trial?
20-24 volunteers, with equal males and females if possible
Why would a subject not be allowed to engage in strenuous activity after receiving an IM injection?
Will affect blood flow to the injection site, which will alter results of study
Are blood or urine samples preferred?
Blood
Which values are tested for a bioequivalence study? Do you want the values to be the same or different?
- Look at AUC, Cmax, and Tmax
- Want them to be as close as possible
What happens when the dose of an oral product must be given in more than one solid form (ex: 2 capsules)?
We would assume that disintegration of both capsules is the same, but that might not be the case, so imposes some form of error
