Bioequivalance

Question 1

What is area under the curve a measure of

Answer 1

Total amount of unaltered drug that reaches systemic circulation

Question 2

What is the criteria for 2 drugs to be bioequivalent

Answer 2

Pharmaceutically equivalent, identical dosage form, contain same active ingredient, same route of administration, identical strength or concentration, formulated to meet same compendial standards

Question 3

What are pharmaceutical alternatives

Answer 3

Same active ingredient, different chemical salt/ester form, different strength or different dosage form

Question 4

When are two products bioequivalent

Answer 4

When they produce such similar plasma drug concentrations that their clinical effects can be expected to be the same

Question 5

Subjects for bioequivalence studies

Answer 5

Healthy male and female subjects, informed consent, generally fasted for 10-12 hrs prior and 2-4 hrs post dose

Question 6

What is power in bioequivalence

Answer 6

The probability of rejecting bioequivalence

Question 7

Study design for bioequivalence

Answer 7

Single dose, 2 period, 2 treatment, 2 sequence open label randomized crossover design, no other meds in week prior to study, compare different products in the same patient

Question 8

What confidence interval is calculated in a bioequivalence study

Answer 8

90%, should fall within prescribed bioequivalence limit of 0.8-1.25

Question 9

What does a 90% confidence interval mean

Answer 9

We are 90% certain that the true population mean is contained within this interval

Question 10

What can an ANOVA reveal

Answer 10

Sequence effects, period effects, treatment effects, inter and intra subject variability

Question 11

When do we not conduct a bioequivalence study

Answer 11

When the drug acts locally as it does not need drug concentration in the plasma measured

Question 12

What sort of data does the ANOVA use

Answer 12

Log transformed data