STAT 191: Bioequivalence and Statistics in Clinical Pharm Biopharmaceutical Development Quiz

Company B wishes to market a drug formulation similar to the approved formulation of Company A with an expired patent. Company B has to prove that they can deliver the same amount of active drug into the blood stream which the approved formula does. The pharmaceutical company does not need to demonstrate the safety and ecacy (through clinical trials) of the drug because that already has been established. Bioequivalence (BE) studies are performed to demonstrate that dierent formulations or regimens of drug product are similar to each other in terms of their therapeutic benet (ecacy) and non-therapeutic side-eects (safety). ___________ studies are performed to demonstrate similarity between different drug formulations.

___________ is a measurement used in bioequivalence studies to assess the similarity of plasma concentration profiles between two drug formulations.

Area under the curve (_______) is an important metric used to compare the total drug exposure between different formulations in bioequivalence testing.

Maximum concentration (_______) is another key parameter evaluated in bioequivalence studies to compare the peak drug concentration achieved by different formulations.

Pharmaceutical scientists use __________ for trials to ensure each participant receives both formulations to compare their effects.

Crossover designs help prevent the confusion of treatment effects with _________ effects.

In bioequivalence testing, the recommended values for ∆1 and ∆2 are 0.80 and 1.25 respectively. We use a two one-sided test after taking the ______.

As the drug is absorbed and distributed, plasma concentration rises and reaches a maximum known as ______.

The ______ measures the overall exposure to the drug.

Adaptive bioequivalence trials allow for prospectively planned modifications based on accumulating data from subjects in the trial to be more flexible, informative, and efficient than traditional trials. CDER statisticians have developed an adaptive trial ______ for demonstrating bioequivalence for highly variable drugs. What is being adjusted in an adaptive bioequivalence trial?

Scaled average bioequivalence focuses on scaling the ______.

Clinical pharmacology efficacy studies evaluate the capacity to produce an effect, for example, lower ______.

The plasma concentration profile is a multivariate response and is a surrogate measure of therapeutic response. The test formulation could be toxic if it yields concentration levels higher than the ______ formulation.

Typically pharmaceutical scientists summarize the rate and extent of drug absorption with summary measurements such as area under the curve (AUC), maximum concentration (Cmax), time at max concentration (Tmax). Michael Daniel C.Lucagbo, PhD STAT 191: Bioequivalence and Statistics in Clinical Pharm Testing Average ______ population bioequivalence - the formulations are equivalent with respect to their underlying probability distributions.

That is, AUC or Cmax distributions would be similar. Average bioequivalence - the formulations are equivalent with respect to the means (medians) of their probability distributions. Individual bioequivalence - the formulations are equivalent for a large proportion of individuals in the ______.

The plasma concentration profile is a multivariate response and is a surrogate measure of therapeutic response. The test formulation could be toxic if it yields concentration levels higher than the reference formulation. The test formulation could be ineffective if it yields concentration levels lower than the ______ formulation.

Typically pharmaceutical scientists summarize the rate and extent of drug absorption with summary measurements such as ______, maximum concentration (Cmax), time at max concentration (Tmax).

Individual bioequivalence - the formulations are equivalent for a large proportion of individuals in the population Michael Daniel C. ______