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Key Statistical Concepts In Clinical Trials For Pharma - ENG

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ISBN: 9781461416623
Formato: ePub
Idioma: Inglés
Editorial: Springer Nature
Tema: Medicina
Subtema: Farmácia
Año de publicación: 2011-10-14

This Brief discusses key statistical concepts that facilitate the inferential analysis 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.

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