Carry-over effects in bioequivalence studies
Carry-over effects are often considered to be one of the main problems of the cross-over design: should we adjust for carry-over or not? We attempt to answer this question by examining the observed frequency of carry-over effects in actual bioequivalence studies. A total of 96 six-sequence, three-period, three-treatment fed-fasted studies are analyzed for carry-over effects and 324 two-sequence, two-period, two-treatment fasted studies are analyzed indirectly for carry-over effects via sequence effects. Two log-transformed pharmacokinetic variables, Cmax and AUC0-t, are modeled in an analysis of variance. The impact of statistically significant carry-over effects on bioequivalence results is examined and the rationale behind not adjusting for carry-over in bioequivalence studies is discussed.
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2001 |
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| Erschienen: |
2001 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
Journal of biopharmaceutical statistics - 11(2001), 1-2 vom: 15. Feb., Seite 35-43 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dangelo, G [VerfasserIn] |
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| Themen: |
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| Anmerkungen: |
Date Completed 11.12.2001 Date Revised 18.07.2001 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM113615817 |
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| 520 | |a Carry-over effects are often considered to be one of the main problems of the cross-over design: should we adjust for carry-over or not? We attempt to answer this question by examining the observed frequency of carry-over effects in actual bioequivalence studies. A total of 96 six-sequence, three-period, three-treatment fed-fasted studies are analyzed for carry-over effects and 324 two-sequence, two-period, two-treatment fasted studies are analyzed indirectly for carry-over effects via sequence effects. Two log-transformed pharmacokinetic variables, Cmax and AUC0-t, are modeled in an analysis of variance. The impact of statistically significant carry-over effects on bioequivalence results is examined and the rationale behind not adjusting for carry-over in bioequivalence studies is discussed | ||
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