Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies

Juan José Torrado (1) , María Blanco (1) , Magí Farré (2, 3) , Pere Roset (4) , Alfredo García-Arieta (5)

1 Departamento Farmacia y Tecnología Farmacéutica, Facultad de Farmacia
2 Unitat de Farmacologia Humana i Neurociències
3 UAB - Universitat Autònoma de Barcelona = Autonomous University of Barcelona = Universidad Autónoma de Barcelona
4 Laboratorios Gelos, Grupo Ferrer
5 Division of Pharmacology and Clinical Evaluation, General Subdirectorate for Human Use Medicines

Mots clés: Ibuprofen; Bioequivalence; Enantiomers; Chirality; Regulatory requirements

Juan José Torrado, María Blanco, Magí Farré, Pere Roset, Alfredo García-Arieta. Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies. European Journal of Clinical Pharmacology, 2010, 66 (6), pp.599-604. ⟨10.1007/s00228-010-0792-7⟩. ⟨hal-00612988⟩