Key Statistical Concepts in Clinical Trials for Pharma
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 dr...
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| Format: | Électronique eBook |
| Langue: | English |
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New York, NY :
Springer New York : Imprint: Springer,
2012.
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| Édition: | 1st ed. 2012. |
| Collection: | SpringerBriefs in Pharmaceutical Science & Drug Development,
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| Accès en ligne: | https://doi.org/10.1007/978-1-4614-1662-3 |
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| Résumé: | 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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| Description matérielle: | IX, 61 p. 1 illus. online resource. |
| ISBN: | 9781461416623 |
| ISSN: | 1864-8118 |