Guidelines for Preparing Core Clinical-Safety Information on Drugs: Including New Proposals for Investigator's Brochures - Couverture souple
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Guidelines for Preparing Core Clinical-Safety Information on Drugs: Including New Proposals for Investigator's Brochures
Edité par
World Health Organisation (WHO), Switzerland, 2001
ISBN 10 : 9290360704
ISBN 13 : 9789290360704
Ancien ou d'occasion
Soft cover
Vendeur : The Book Exchange, Macclesfield, CHESH, Royaume-Uni
Évaluation du vendeur 5 sur 5 étoiles
Soft cover. Etat : Near Fine. 9290360704. Second edition near fine softcover, from closed Astra Zeneca company library. 98 pages, appendices. A revised edition of the minimum drug safety information that should be communicated by manufacturers to physicians and other prescribers. Includes the report of CIOMS Working Group V, which extends the original guidelines to include safety information on drugs undergoing investigation. The report of Working Group V is published as an additional set of proposals for the assessment of safety information. Proposals are intended to provide researchers with clinical and non-clinical information and to assist pharmaceutical companies in meeting their reporting obligations. Guidance is provided on the global distribution to investigators of new safety information, such as 7-day and 15-day alerts to serious, unexpected adverse reaction. The proposals should facilitate the work of ethics review committees when assessing the benefits and risks to participants in clinical trials. The book concludes with the text of the European Summary of Product Characteristics and a summary of the US FDA Requirements, examples of illustrative drug scenarios used by the working group, and a model of Core Safety Information proposed for a fictitious drug. Contents clean, tight and bright. Book. N° de réf. du vendeur 030215
Acheter D'occasion
EUR 26,81
Expédition à EUR 23,17
Expédition depuis Royaume-Uni vers Etats-Unis
Expédition depuis Royaume-Uni vers Etats-Unis
Quantité disponible : 1 disponible(s)
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Guidelines for Preparing Core Clinical-safety Information on Drugs: Including New Proposals for Investigator*s Brochures
Edité par
World Health Organisation (WHO), 1999
ISBN 10 : 9290360704
ISBN 13 : 9789290360704
Ancien ou d'occasion
paperback
Vendeur : Mispah books, Redhill, SURRE, Royaume-Uni
Évaluation du vendeur 4 sur 5 étoiles
paperback. Etat : Very Good. Very Good. Dust Jacket may NOT BE INCLUDED.CDs may be missing. SHIPS FROM MULTIPLE LOCATIONS. book. N° de réf. du vendeur ERICA82992903607043
Acheter D'occasion
EUR 194,52
Expédition à EUR 28,97
Expédition depuis Royaume-Uni vers Etats-Unis
Expédition depuis Royaume-Uni vers Etats-Unis
Quantité disponible : 1 disponible(s)