Chapter 7 Bioavailability and Bioequivalence

Chapter 7  今日のメモ☆
Bioavailability（生物学的利用能） とBioequivalence（生物学的同等性）のお話

Relative & Absolute bioavailability
 Relative bioavailability（相対的バイオアベイラビリティ
  RBA = ([AUC]oral test / Dose oral test) / ([AUC] oral ref / Dose oral ref)
 
Absolute bioavailability（絶対的バイオアベイラビリティ）:異なる投与経路においてその吸収性の違いを評価
  F = ([AUC]oral / Dose oral) / ([AUC] iv / Dose iv)

Bioavilabilityを評価する指標
 - Tmax
 - Cmax
 - AUC

Bioequivalence studies compare the bioavailability of a drug from one drug product to another drug product containing the same active ingredient.(ex. tablet, capsule)  Generic drug products and the corresponding brand drug product must be bioequivalent.  For any change a formulation, the manufacturer(brand or generic) must demonstrate that the formulation change does not affect the bioavailability compared to the original product.

Today's question
- Bioequivalence(生物学的同等性)の問題
Q: For two drug products, generic(test) and brand(reference), to be considered bioequivalent
(I) there should be no stastical difference between the extent of bioavailability of the drug from the test product compared to the reference product.
(II) the 90% confidence intervals about the ratio of the means of the Cmax and AUC values for the test product to reference product must be within 80% - 125% of the reference product.
(III) there should be no statistical differences between the mean Cmax and AUC values for the test product compared to the reference product.

A if I only is correct
B if III only is correct
C if I and II are correct
D if II and III are correct
E if I, II and III are correct
 

A: (E)