Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report
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0092-8615/2000
Copyright 0 Z o o 0 Drug Informalion Association Inc.
CARCINOGENICITY TESTING OF PHARMACEUTICALS IN THE EUROPEAN UNION: A WORKSHOP REPORT PER SPINDLER, DVM Danish Medicines Agency, Bronshoj, Denmark
JAN-WILLEM VAN DER LAAN,PHD Preclinical Assessment Group of the Medicines Evaluation Board, Laboratory for Medicines and Medical Devices, National lnstitute of Public Health and the Environment, Bilthoven. The Netherlands
PETER
CEUPPENS, PHD
AstraZeneca, Macclesfield, Cheshire, United Kingdom
ROBERTHARLING,MSc Huntingdon Life Sciences, Huntingdon, United Kingdom
ROBERTE-ITLIN,PHD Novartis Pharma AG, Basel, Switzerland
BEATRIZSILVALIMA,PHD INFARMED, Lisbon, Portugal
Recently, documents have been developed by the International Conference on Harmonisation (ICH) to guide industry on when long-term carcinogenicity bioassays are needed, testing strategy approaches, selection of the high dose, toxicokinetic evaluations, and preclinical testing of biotechnology-derived medicinal products. In the European Union (EU), the CPMP guideline on testing for carcinogenic potential was issued in 1983. Where the ICH guidelines overlap the old guideline, the industry should refer to these guidelines. Aspects of test designs and data analysis of the Committee for Proprietary Medicinal Products (CPMC) guideline need to be updated to reflect the current state of testing. This report summarizes the outcome of discussions at a DIA workshop held in September 1999 in Switzerland. Discussions included threshold concepts of nongenotoxic compounds, practical features of testing, statistical design of the study; terminal investigations, including a list of tissues to be examined histologically: principles of reporting and analysis of data: and the use of short-term carcinogenic studies, that is, aspects of the CPMP guideline which are not covered by the ICH guidelines. Key Words: Pharmaceuticals; Carcinogenicity; Bioassay; Guideline; CPMP
This is a workshop report from the DIA “Workshop on Carcinogenicity Testing of Pharmaceuticals in the European Union,” September 1-2, 1999, Zurich, Switzerland. The workshop was organized by Dr. Jan-Willem van der Laan and Dr. Per Spindler. Reprint address: Per Spindler, Novo Nordisk A / S , Regulatory Process Development, Niels Steensens Vej 1, DK-2820 Gentofte Denmark.
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Per Spindler et al.
WORKSHOP RATIONALE AND OUTLINE A GUIDELINE OF THE Committee for Proprietary Medicinal Products on carcinogenic potential of pharmaceuticals for use in man was adopted in 1983 on the legislative basis of Council Directive 75/3 18/EEC. Since that time, a number of guidelines on carcinogenicity testing and toxicokinetics have been developed through the process of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Dose Selection f o r Carcinogenicity Studies of Pharmaceuticals (S lCR, CPMP/ICW
366/95), The Need f o r Carcinogenicity Studies of Pharmace
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