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This new edition of "Good Practice" is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: Rationale for each rule presented ; Safety of data in clinical trials ;Protection of personal data ; Conflicts of interest ; Measures to be taken in case of suspected fraud
|TAILLE DU FICHIER||6,65 MB|
|DATE DE PUBLICATION||2004-Jul-01|
Clinical trials are experiments or observations done in clinical research.Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant ...