Abstract
The development of new medicines, including drugs, for use in radiology has made it possible to diagnose, treat, and prevent a number of previously refractory diseases. Due to the necessary intensification of demands by the health authorities, the time required to develop new drugs has increased. Regulations have come into force regarding both production processes (Good Manufacturing Practice, GMP) and preclinical investigational programs (Good Laboratory Practice, GLP).
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Ankier SI, Warrington SJ (1989) Research and development of new medicines. J Int Med Res 17:407–416.
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.
Hvidberg EF (1994) Clinical trials on medicinal products (in Danish). Ugeskr Laeger 156:789–793.
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.
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).
World Health Organization (1993) WHO Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. Division of drug management and policies.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1999 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Stilbo, I.M. (1999). Phase I, II, III, and IV Studies: Good Clinical Practice. In: Thomsen, H.S., Muller, R.N., Mattrey, R.F. (eds) Trends in Contrast Media. Medical Radiology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-59814-2_5
Download citation
DOI: https://doi.org/10.1007/978-3-642-59814-2_5
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-64136-7
Online ISBN: 978-3-642-59814-2
eBook Packages: Springer Book Archive