Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons.
Purpose: Adjusted indirect comparisons can be used to investigate bioequivalence between generic products that are bioequivalent with a common reference product. In previous work with generic tuberculosis medicines prequalified by the WHO, it was observed that although indirect comparisons are an ef...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 71; no. 9; pp. 1083 - 1090 |
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| Autores principales: | , , , , , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Springer Nature
Sep2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=108841029&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 108841029 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Sep2015 vid: 71 iid: 9 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 108841029 108841029 108841029 10.1007/s00228-015-1889-9 108841029 ppf: 1083 ppct: 7 formats: fmt: @attributes: type: P tig: atl: Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons. aug: au: Gwaza, Luther Gordon, John Potthast, Henrike Welink, Jan Leufkens, Hubert Stahl, Matthias García-Arieta, Alfredo affil: Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa Canada sug: subj: Drugs, Generic Pharmacodynamics Drugs, Prescription Analysis Chemical and Pharmacologic Phenomena Antitubercular Agents Analysis Pharmacokinetics Confidence Intervals Drug Evaluation Data Analysis Software ab: Purpose: Adjusted indirect comparisons can be used to investigate bioequivalence between generic products that are bioequivalent with a common reference product. In previous work with generic tuberculosis medicines prequalified by the WHO, it was observed that although indirect comparisons are an effective approach for confirming the interchangeability of generics, the approach is subject to less precision than direct comparisons. The objective of this investigation was to explore this by examining the influence of point estimates and power of bioequivalence studies versus the reference on the ability to show equivalence in indirect comparisons. Methods: Power was considered as a determining factor instead of variability and sample size, because sample size is calculated based on variability and desired power. Scenarios were computed combining a range of point estimate differences (0-14 %) and statistical power of the studies (50-99.99 %). Results: The indirect comparisons could conclude equivalence between generics only when (a) point estimate differences between generics were low (≤5.5 %) for any sufficiently powered study (>80 %), or (b) the differences were large (but less than 14 %) and both bioequivalence studies were overpowered (e.g., 10 % difference and power ≥95 %). Conclusions: In summary, the ability to demonstrate interchangeability between generics is dependent not only on the real differences between the products but also on the design of the original generic vs. reference bioequivalence studies being combined, as earmarked by their respective power. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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