Key Statistical Concepts in Clinical Trials for Pharma

Nonfiction, Health & Well Being, Medical, Specialties, Pharmacy, Science & Nature, Technology
Cover of the book Key Statistical Concepts in Clinical Trials for Pharma by J. Rick Turner, Springer New York
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Author: J. Rick Turner ISBN: 9781461416623
Publisher: Springer New York Publication: October 14, 2011
Imprint: Springer Language: English
Author: J. Rick Turner
ISBN: 9781461416623
Publisher: Springer New York
Publication: October 14, 2011
Imprint: Springer
Language: English

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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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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