| Description |
1 online resource (ix, 61 pages) |
| Series |
SpringerBriefs in pharmaceutical science & drug development, 1864-8118 |
|
SpringerBriefs in pharmaceutical science & drug development.
|
| Contents |
Machine generated contents note: 1. Setting the Scene -- 1.1. Introduction -- 1.2. Discipline of Statistics -- 1.3. Generalizing Information Gained from a Clinical Trial -- 1.4. Blood Pressure -- 1.4.1. Physiology and Measurement of Blood Pressure -- 1.4.2. Cautionary Tale About Blood Pressure Measurement -- 1.5. Statistical Concepts and Nomenclature -- 1.5.1. Drug Safety -- 1.5.2. Drug Efficacy -- 1.5.3. Statistical Significance and Clinical Significance -- References -- 2. Analyzing Safety Data -- 2.1. Introduction -- 2.2. Providing Safety Data to Prescribing Physicians and Patients -- 2.3. Clinical Study Report -- 2.4. Subject Demographics and Accountability -- 2.5. Safety Parameters Measured -- 2.6. Adverse Events -- 2.7. From Descriptive Statistics to Inferential Statistics -- 2.8. Prospective Exclusion of Unacceptable Risk -- 2.8.1. Assessment of Unacceptable Cardiac Risk -- 2.8.2. Assessment of Unacceptable Cardiovascular Risk -- 2.8.3. More Realistic Scenario and its Unintended Consequences -- References -- 3. Assessing Efficacy Data -- 3.1. Introduction -- 3.2. Probability -- 3.3. Statistically Significant Efficacy and Hypothesis Testing -- 3.3.1. Straightforward Example -- 3.3.2. Quick Detour: Degrees of Freedom -- 3.3.3. Returning to Our Example -- 3.3.4. Second Method of Analysis: ANOVA -- 3.4. Clinically Significant Efficacy and Confidence Intervals -- 3.5. Emphasizing an Earlier Point -- References -- 4. Confidence Intervals: Additional Commentary -- 4.1. Introduction -- 4.2. Logic of Confidence Intervals -- 4.3. Differing Confidence Intervals Differ in Width -- 4.4. Employment of Confidence Intervals in Both Safety and Efficacy Analyses -- 4.4.1. Equidistant and Non-Equidistant Confidence Intervals -- ̂ 4.5. Limit of Primary Interest -- 4.6. Relationship Between Confidence Intervals and Probability Levels |
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Note continued: 4.6.1. Cases in Which the Null Value is Zero -- 4.6.2. Cases in Which the Null Value is Unity -- 5. Meta-Methodology -- 5.1. Introduction -- 5.2. Unbridled Bravado is Inappropriate When Presenting Results -- 5.3. Fundamentals of Meta-Methodology -- 5.4. Data Analysis: Fixed-Effect and Random-Effect Models -- 5.5. Evaluating Heterogeneity -- 5.6. Evaluating Robustness -- 5.7. Hypothesis Generation and Hypothesis Testing -- 5.8. Results and Conclusions -- References -- 6. Benefit-Risk Estimation -- 6.1. Introduction -- 6.2. Drug Safety -- 6.3. Decision Making -- 6.4. Subjective Nature of Many Decisions -- 6.5. Determining and Enforcing Thresholds of Regulatory Concern -- 6.6. Decision Analysis and Decision Making -- 6.7. Qualitative and Quantitative Considerations -- References |
| Summary |
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 |
| Analysis |
Medicine |
|
Pharmaceutical technology |
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Biomedicine |
|
Pharmaceutical Sciences/Technology |
|
biomedische wetenschappen |
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farmacologie |
|
pharmacology |
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Medicine (General) |
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Geneeskunde (algemeen) |
| Bibliography |
Includes bibliographical references |
| Subject |
Drug development.
|
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Drugs -- Testing.
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Risk assessment.
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Drug Evaluation
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Clinical Trials as Topic
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Data Interpretation, Statistical
|
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Risk Assessment
|
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risk assessment.
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MEDICAL -- Pharmacology.
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Risk assessment
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Drug development
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Drugs -- Testing
|
| Form |
Electronic book
|
| ISBN |
9781461416623 |
|
1461416620 |
|
