Manual of Drug Safety and Pharmacovigilance + cd-rom

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Descrição

Contents:
Ch. 1 The theory and definitions of drug safety (pharmacovigilance) 1
Ch. 2 Clinical trials, clinical research organizations, phases I-IV, and investigator-initiated trials 5
Ch. 3 Spontaneous postmarketing adverse events 11
Ch. 4 The theory of drug safety (pharmacovigilance) 15
Ch. 5 Adverse events with new chemical entities, generics, excipients, and placebos 21
Ch. 6 Acute and chronic (late occurring) adverse events, adverse events that disappear (Bendectin), and diethylstilbestrol 25
Ch. 7 The mathematics of adverse events 29
Ch. 8 Organizations : the US food and drug administration and MedWatch 33
Ch. 9 Organizations : European medicines agency 39
Ch. 10 Where data reside 43
Ch. 11 Signals and signaling in the context of risk management 45
Ch. 12 Data privacy and sharing 53
Ch. 13 The roles of academia, companies, government health authorities, nongovernmental organizations (NGOs), consumer groups, and gadflies in the world of pharmacovigilance 57
Ch. 14 Risk : what is it? : risk management and assessment 63
Ch. 15 The US food and drug administrations premarketing risk assessment guidance of March 2005 65
Ch. 16 The US food and drug administrations development and use of risk minimization action plans guidance of March 2005 71
Ch. 17 The US food and drug administrations good pharmacovigilance practices and pharmacoepidemiologic assessment guidance of March 2005 75
Ch. 18 Epidemiology and pharmacoepidemiology : what are they? : what are their limitations and advantages? 81
Ch. 19 Product quality issues 85
Ch. 20 Pregnancy, lactation, and adverse events (AEs) : AEs in pregnant partners of males taking a drug, pregnancy, registries, and the Swedish pregnancy registry 89

Informação adicional

Peso 3 kg
Autor

COBERT

ISBN

9780763738891

ISBN10

0763738891

Editora

JONES&BARTLETT

Número de Páginas

292 pags.

Idioma

Ingles

Ano

2007