caa a22 4500 477058086 CHVBK 20180405111352.0 cr unu---uuuuu 170330e19960101xx s 000 0 eng 10.1007/BF00226323 doi (NATIONALLICENCE)springer-10.1007/BF00226323 Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies [Elektronische Daten] [L. Aarons, M. Rowland, L. Balant, F. Mentré, P. Morselli, J. Steimer, S. Vozeh] An expert meeting to discuss issues relating to the design of population pharmacokinetic/pharmacodynamic (PK/PD) studies was held in Brussels in March 1995, under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. The purpose of the meeting was to discuss the experts' experience in designing and performing population PK/PD studies. The topics discussed were current practice, logistical issues, ensuring the accuracy of data, covariate assessment, communication, and protocol design. The main conclusions from the meeting were: 1) a population PK/PD analysis should be one of the objectives of a clinical trial and should not compromise the other objectives; 2) it is particularly important to communicate the purpose of the population PK/PD analysis to the investigators and to convince them of the importance of accurately recording dosing and sampling times; 3) some prior knowledge of the PK and PD models and covariate relationships is necessary for the analysis of sparse phase III data; 4) computer simulation and optimal design measures may be useful in defining sampling times; 5) population methods and objectives must be specified as completely as possible in the protocol. Participants: L. Aarons (UK), L. Balant (Switzerland), P. Bechtel (France), R. Bruno (France), P. Burtin (Switzerland), C. Dubruc (France), E. Fuseau (UK), J. Gabrielsson (Sweden), U. Gundert-Remy (Germany), R. Jochemsen (France), M. Karlsson (Sweden), C. Laveille (France), I. Meineke (Germany), F. Mentré (France), P. Morselli (France), G. Paintaud (France), A. Racine-Poon (Switzerland), J. Rodriguez (Spain), F. Rombout (The Netherlands), M. Rowland (UK), J.-L. Steimer (Switzerland), A. Van Peer (Belgium), S. Vozeh (Switzerland), W. Weber (Germany), B. Wittke (Switzerland) The views expressed by the participants do not necessarily reflect those of the organizations they represent. Springer-Verlag, 1996 Population pharmacokinetics nationallicence Pharmacodynamics nationallicence experimental design nationallicence drug development nationallicence clinical trials nationallicence Aarons L. Department of Pharmacy, University of Manchester, Oxford Road, M13 9PL, Manchester, UK aut Rowland M. Department of Pharmacy, University of Manchester, Oxford Road, M13 9PL, Manchester, UK aut Balant L. Clinical Research Unit, Department of Psychiatry, University of Geneva, Switzerland aut Mentré F. INSERM U436, CHU Pitie-Salpetriere, Paris, France aut Morselli P. Buc, France and Department of Clinical Pharmacology, Hospital "Trias i Pujol” Badalona, Universidad Autonoma Barcelona, Spain aut Steimer J. Drug Safety, Sandoz Pharma AG, Basel, Switzerland aut Vozeh S. Office Intercantonal de Contrôle des Médicaments, Berne, Switzerland aut European Journal of Clinical Pharmacology Springer-Verlag 49/4(1996-01-01), 251-254 0031-6970 49:4<251 1996 49 228 https://doi.org/10.1007/BF00226323 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF00226323 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Aarons L. Department of Pharmacy, University of Manchester, Oxford Road, M13 9PL, Manchester, UK aut NATIONALLICENCE 700 1- Rowland M. Department of Pharmacy, University of Manchester, Oxford Road, M13 9PL, Manchester, UK aut NATIONALLICENCE 700 1- Balant L. Clinical Research Unit, Department of Psychiatry, University of Geneva, Switzerland aut NATIONALLICENCE 700 1- Mentré F. INSERM U436, CHU Pitie-Salpetriere, Paris, France aut NATIONALLICENCE 700 1- Morselli P. Buc, France and Department of Clinical Pharmacology, Hospital "Trias i Pujol” Badalona, Universidad Autonoma Barcelona, Spain aut NATIONALLICENCE 700 1- Steimer J. Drug Safety, Sandoz Pharma AG, Basel, Switzerland aut NATIONALLICENCE 700 1- Vozeh S. Office Intercantonal de Contrôle des Médicaments, Berne, Switzerland aut NATIONALLICENCE 773 0- European Journal of Clinical Pharmacology Springer-Verlag 49/4(1996-01-01), 251-254 0031-6970 49:4<251 1996 49 228 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer