This Brief discusses key statistical concepts that facilitate the inferentialanalysis of data collected from a group of individuals participating in a pharmaceutical clinical trial, the estimation of their clinical significance in the general population of individuals likely to be prescribed the drug if approved, and the related decision-making that occurs at both the public health level (by regulatory agencies when deciding whether or not to approve a new drug for marketing) and the individual patient level (by physicians and their patients when deciding whether or not the patient should be prescribed a drug that is on the market). These concepts include drug safety and efficacy, statistical significance, clinical significance, and benefit-risk balance.
- ISBN: 978-1-4614-1661-6
- Editorial: Springer New York
- Encuadernacion: Rústica
- Páginas: 61
- Fecha Publicación: 28/11/2011
- Nº Volúmenes: 1
- Idioma: Inglés