Bioequivalence and Bioavailability Forum

rohitkachhadiya ☆ Gujarat, 2013-04-19 13:46 (4408 d 12:42 ago) Posting: # 10436 Views: 4,422	Replicate/Partial Replicate design acceptance criteria [RSABE / ABEL] Post reply
	Dear All, As mentioned in the OGD of Progesterone Capsule Page 3 step 3 a. the 95% upper confidence bound for (Yt-Yr)^2 -ØS^2 must be ≤ 0 My question is Why only upper limit is consider for acceptance criteria? Edit: Category changed. [Helmut]

Helmut
★★★

Vienna, Austria,
2013-04-19 16:12
(4408 d 10:16 ago)

@ rohitkachhadiya
Posting: # 10437
Views: 4,555

linearized form (Howe’s approximation)

Hi Rohit,

❝ a. the 95% upper confidence bound for (Yt-Yr)^2 -ØS^2 must be ≤ 0

❝

❝ My question is Why only upper limit is consider for acceptance criteria?

Since the SABE model

–θ_s ≤ (μ_T – μ_R) ∕ σ_W ≤ θ_s

is rearranged and linearized to

(μ_T – μ_R)² – θ_s²·σ_W² ≤ 0.

For an overview see this lecture (slides 23–25) and details in the following references:

Hyslop T, Hsuan F, Holder DJ. A small sample conﬁdence interval approach to assess individual bioequivalence. Stat Med. 2000;19(20):2885–97. doi 10.1002/1097-0258(20001030)19:20<2885::AID-SIM553>3.0.CO;2-H
Haidar SH et al. Bioequivalence Approaches for Highly Variable Drugs and Drug Products. Pharm Res. 2008;25(1):237–41. doi 10.1007/s11095-007-9434-x
Haidar SH et al. Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs. AAPS J. 2008;10(3):450–4. doi 10.1208/s12248-008-9053-4
Endrényi L, Tóthfalusi L.Regulatory conditions for the determination of bioequivalence of highly variable drugs. J Pharm Pharm Sci. 2009;12:138–49. free online
Tóthfalusi L, Endrényi L, García-Arieta A. Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence. Clin Pharmacokinet. 2009;48(11):725–43. doi 10.2165/11318040-000000000-00000
Karalis V, Symillides M, Macheras P. Bioequivalence of Highly Variable Drugs: A Comparison of the Newly Proposed Regulatory Approaches by FDA and EMA. Pharm Res. 2012;29(4):1066–77. doi 10.1007/s11095-011-0651-y

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Helmut Schütz

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