Regulation of Medical Products

Häftad, Engelska, 2003

Av John Griffin, John O'Grady, John (University of Surrey Postgraduate Medical School) Griffin, UK) O'Grady, John (Visiting Professor of Clinical Pharmacology, London

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A concise but comprehensive text explaining the processes involved in regulation of drugs with particular emphasis on EU, USA and Australia.

Produktinformation

Utgivningsdatum2003-04-03
Mått158 x 236 x 20 mm
Vikt481 g
FormatHäftad
SpråkEngelska
Antal sidor310
FörlagJohn Wiley & Sons Inc
ISBN9780727917805

Tillhör följande kategorier

Tillverkningsindustri inom Ekonomi och ledarskap
Farmakologi inom Medicin

Contributors. Preface.Acknowledgements.The Editors.History of drug regulation in the UK.Regulation of human medicinal products in the European Union.European regulation of medical devices.The supply of unlicensed medicines for particular patient use.Controls on NHS medicines prescribing and expenditure in the UK (a historical perspective).The regulation of therapeutic products in Australia.Regulatory and clinical trial systems in Japan.The regulation of drug products by the United States Food and Drug Administration.The US FDA in the drug development, evaluation, and approval process.Technical requirements for registration of pharmaceuticals for human use: the ICH process and the Common Technical Document.Appendix: European guidelines relevant for pharmaceutical physicians.Index

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