A key text for all those involved in pharmacovigilance. Detection of new adverse drug reactions is fundamental to the protection of patients from harm that may occur as a result of medication. This book explores the methods used to investigate new adverse drug reactions, discussing all elements from the scientific background and animal toxicology through to worldwide regulatory and ethical issues. Stephens' Detection of New Adverse Drug Reactions provides comprehensive and up-to-date coverage of material fundamentally important to all those active in the field, whether they work in the pharmaceutical industry, drug regulatory authorities or in academia. The fifth edition of this classic reference work includes new chapters on: vaccine safety surveillance managing drug safety issues with marketed products operational aspects of drug safety function safety of biotechnology products future of pharmacovigilance Reviews of previous editions: qThis book surpasses all its educational aims. Not only is the subject matter covered comprehensively but the material is presented in a very user-friendly manner. The editors have succeeded in producing a highly-specific, definitive reference book which doubles as a most enjoyable read.q aCommended by the 1999 BMA Medical Book Competition qFor anyone entering the field of adverse reaction monitoring one could not wish for a better primerq aInternational Journal of Risk and Safety in MedicineIt is unclear whether there will be a need for the European Medicines Evaluation Agency (EMEA) to provide specific expertise in this area. Although regulatory authorities may feel ... that are currently provided as warnings. The new European Guideline on this subject (III/5218/97, final approval September 1998) provides an opportunity to improve the readability of the label and patient information leafletsanbsp;...
|Title||:||Stephens' Detection of New Adverse Drug Reactions|
|Author||:||John Talbot, Patrick Waller|
|Publisher||:||John Wiley & Sons - 2004-11-19|