Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons

European Journal of Clinical Pharmacology - Tập 71 Số 9 - Trang 1083-1089 - 2015
Luther Gwaza1, John Gordon2, Henrike Potthast3, Jan Welink4, Hubert G.M. Leufkens1, Matthias Stahl5, Alfredo García‐Arieta6
1Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands
2Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada
3Sub Department of Biostatistics and Pharmacokinetics, Federal Institute for Drugs and Medical Devices, Bonn, Germany
4Medicines Evaluation Board, Utrecht, The Netherlands
5Prequalification Team – Medicines, Regulation of Medicines and Other Health Technologies, Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland
6División de Farmacología y Evaluación Clínica, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain

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