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http://hdl.handle.net/1942/8542
Title: | Including information on the therapeutic window in bioequivalence acceptance | Authors: | JACOBS, Tom De Ridder, Filip Rusch, Sarah Van Peer, Achiel MOLENBERGHS, Geert BIJNENS, Luc |
Issue Date: | 2008 | Publisher: | SPRINGER/PLENUM PUBLISHERS | Source: | PHARMACEUTICAL RESEARCH, 25(11). p. 2628-2638 | Abstract: | Purpose. A novel bioequivalence limit is proposed taking into account the therapeutic window. Methods. The therapeutic range is introduced as the ratios maximum tolerated dose/therapeutic dose (MTD/D) and the therapeutic dose/lowest effective dose. The performance of the new acceptance range was compared with the methods of Schuirmann and Karalis. The method was retrospectively applied to data of three drugs with a narrow therapeutic window (phenytoin, theophylline and digoxin). Results. Simulations and examples show that the resulting bioequivalence limits are (1) narrow for narrow-index drugs, (2) expanded for highly variable drugs with a wide therapeutic window and (3) similar to the classical limits for less variable drugs with a wide therapeutic range. Conclusions. The approach has the desirable property of resulting in a more narrow acceptance range for doses near the boundaries of the therapeutic window and a wider acceptance range for products with a broad therapeutic window. | Notes: | [Jacobs, Tom; Molenberghs, Geert] Univ Hasselt, Interuniv Inst Biostat & Stat Bioinformat, B-3590 Diepenbeek, Belgium. [De Ridder, Filip; Rusch, Sarah; Van Peer, Achiel; Bijnens, Luc] Johnson & Johnson Pharmaceut Res & Dev, B-2340 Beerse, Belgium. [Molenberghs, Geert] Katholieke Univ Leuven, Int Inst Biostat & Stat Bioinformat, B-3000 Leuven, Belgium. | Keywords: | average bioequivalence; bioavailability; individual bioequivalence; therapeutic window;average bioequivalence; bioavailability; individual bioequivalence; therapeutic window | Document URI: | http://hdl.handle.net/1942/8542 | ISSN: | 0724-8741 | e-ISSN: | 1573-904X | DOI: | 10.1007/s11095-008-9680-6 | ISI #: | 000259742300017 | Rights: | (c) 2008 Springer Science + Business Media, LLC | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2009 |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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GeertMolenberghs24.pdf | Peer-reviewed author version | 341.45 kB | Adobe PDF | View/Open |
jacobs2008.pdf Restricted Access | Published version | 268.89 kB | Adobe PDF | View/Open Request a copy |
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