4 Ideas to Supercharge Your Statistical Methods To Analyze Bioequivalence

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Enter the email address you signed up with and well email you a reset link. To browse Academia. From a clinical viewpoint, not only are these prequalified generics bioequivalent and interchangeable with the reference product (Coartem, Novartis), but visit this page the existing indirect evidence makes it possible to conclude that these WHO prequalified products are bioequivalent between themselves with respect to the AUC. Methods based on the assumption of a large sample size give slightly narrower 90 % confidence intervals. To achieve this goal, generic artemether/lumefantrine 20/120 mg tablets that have been prequalified by the World Health Organization (WHO) were selected as model products for study. edu and the wider internet faster and more securely, please take a few seconds toupgrade your browser.

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org/10. However, given the precision of the drug peak concentration (Cmax) data, it is not possible to demonstrate equivalence within the conventional acceptance range for all comparisons; it is possible to conclude bioequivalence within the widened acceptance range 75–133 %. Instant access to the full article PDF. Correspondence to
Alfredo García-Arieta.

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The different methods of indirect comparison examined in this study provide consistent results. Learn more about Institutional subscriptionsAcademia. Products in other therapeutic categories are now also assessed. Learn more about Institutional subscriptionsThe WHO Prequalification of Medicines Programme was launched in 2001, in partnership with UNAIDS, UNICEF, and UNFPA, with support from the World Bank.

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39,95 €Price includes VAT (Pakistan)Rent this article via DeepDyve. The objective of this study was to compare different methods of adjusted indirect comparisons that can be used to investigate the relative bioavailability of different generic products. Given the precision of the area under the time–concentration curve (AUC) data, it is possible to conclude that the extent of exposure of artemether and lumefantrine is bioequivalent between the different generics studied. Enter the email address you signed up with and well email you a reset link. It also inspects contract research organizations (CROs) to verify compliance of the bioequivalence studies with good clinical practice (GCP) and good laboratory practices (GLP). The Programme reviews product dossiers, mainly for generic products, according to stringent, internationally accepted criteria, including data on product quality and bioequivalence, and inspects the corresponding manufacturing sites to assess compliance with good manufacturing practices (GMP).

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The lack of the necessary precision to demonstrate bioequivalence between generics with respect to the Cmax within the conventional acceptance range does not preclude considering them as interchangeable, if necessary, since Cmax is considered to be of less clinical relevance for the relevant therapy. edu and the wider internet faster and more securely, please take a few seconds toupgrade your browser. Therefore, the use of methods based on the t test is recommended. Its original focus was the evaluation of medicines for treatment of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria, and tuberculosis.

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This manuscript represents the personal opinion of the authors and does not necessarily represent the views or policy of their corresponding Regulatory Agencies or the World Health OrganizationReceived: 27 May 2012Accepted: 29 August 2012Published: 21 September 2012Issue Date: December 2012DOI: https://doi. 39,95 €Price includes VAT (Pakistan)Rent this article via DeepDyve. Data from three bioequivalence studies conducted independently that compared three generics with the same reference product were used to indirectly determine the relative bioavailability between the generics themselves. read more browse Academia. 1007/s00228-012-1396-1Instant access to the full article PDF.

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