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http://hdl.handle.net/1942/8542
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DC Field | Value | Language |
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dc.contributor.author | JACOBS, Tom | - |
dc.contributor.author | De Ridder, Filip | - |
dc.contributor.author | Rusch, Sarah | - |
dc.contributor.author | Van Peer, Achiel | - |
dc.contributor.author | MOLENBERGHS, Geert | - |
dc.contributor.author | BIJNENS, Luc | - |
dc.date.accessioned | 2008-10-31T10:39:19Z | - |
dc.date.available | 2008-10-31T10:39:19Z | - |
dc.date.issued | 2008 | - |
dc.identifier.citation | PHARMACEUTICAL RESEARCH, 25(11). p. 2628-2638 | - |
dc.identifier.issn | 0724-8741 | - |
dc.identifier.uri | http://hdl.handle.net/1942/8542 | - |
dc.description.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. | - |
dc.description.sponsorship | Financial support from the IAP Research Network P6/03 of the Belgian Government (Belgian Science Policy) is gratefully acknowledged. | - |
dc.format.extent | 349646 bytes | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER/PLENUM PUBLISHERS | - |
dc.rights | (c) 2008 Springer Science + Business Media, LLC | - |
dc.subject.other | average bioequivalence; bioavailability; individual bioequivalence; therapeutic window | - |
dc.subject.other | average bioequivalence; bioavailability; individual bioequivalence; therapeutic window | - |
dc.title | Including information on the therapeutic window in bioequivalence acceptance | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 2638 | - |
dc.identifier.issue | 11 | - |
dc.identifier.spage | 2628 | - |
dc.identifier.volume | 25 | - |
local.format.pages | 11 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.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. | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.bibliographicCitation.oldjcat | A1 | - |
dc.identifier.doi | 10.1007/s11095-008-9680-6 | - |
dc.identifier.isi | 000259742300017 | - |
item.fulltext | With Fulltext | - |
item.contributor | JACOBS, Tom | - |
item.contributor | De Ridder, Filip | - |
item.contributor | Rusch, Sarah | - |
item.contributor | Van Peer, Achiel | - |
item.contributor | MOLENBERGHS, Geert | - |
item.contributor | BIJNENS, Luc | - |
item.accessRights | Open Access | - |
item.fullcitation | JACOBS, Tom; De Ridder, Filip; Rusch, Sarah; Van Peer, Achiel; MOLENBERGHS, Geert & BIJNENS, Luc (2008) Including information on the therapeutic window in bioequivalence acceptance. In: PHARMACEUTICAL RESEARCH, 25(11). p. 2628-2638. | - |
item.validation | ecoom 2009 | - |
crisitem.journal.issn | 0724-8741 | - |
crisitem.journal.eissn | 1573-904X | - |
Appears in Collections: | Research publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
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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