1 Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products, Madrid, Spain. Electronic address: agarciaa@aemps.es.
2 Division of Biopharmaceutics Evaluation, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, Canada.
3 Subdepartment of Biostatistics and Pharmacokinetics, Federal Institute for Drugs and Medical Devices, Bonn, Germany.