1. Ankier SI, Warrington SJ (1989) Research and development of new medicines. J Int Med Res 17:407–416.
2. Commission of the European Communities (1990) Good Clinical Practice for Trials on Medicinal Products in the European Community. In: The rules governing medicinal products in the European Community, vol. Ill, addendum July 1990, pp 57–98.
3. Hvidberg EF (1994) Clinical trials on medicinal products (in Danish). Ugeskr Laeger 156:789–793.
4. Legrand C, Cheix F, Dumais H, Laugel V, De Cremier F, Dupont C (1995) Clinical trial initiation procedures in Europe: the legal framework and practical aspects. Drug Information J 29:201–259.
5. The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit (1996) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95).