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Pharmaceutical Statistics Practical and Clinical Applications Revised and Expanded 4th Edition by Sanford Bolton, Charles Bon ISBN 0824746953 9780824746957

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Pharmaceutical Statistics Practical and Clinical Applications Revised and Expanded 4th Edition Sanford Bolton Digital Instant Download

Author(s): Sanford Bolton, Charles Bon
ISBN(s): 9780824746957, 0824746953
Edition: 4
File Details: PDF, 12.84 MB
Year: 2003
Language: english
SKU: EB-5694584 Category: Tags: ,

Pharmaceutical Statistics Practical and Clinical Applications Revised and Expanded 4th Edition by Sanford Bolton, Charles Bon – Ebook PDF Instant Download/Delivery: 0824746953, 9780824746957
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Product details:

ISBN 10: 0824746953 
ISBN 13: 9780824746957
Author: Sanford Bolton, Charles Bon

The fourth edition of a bestselling text, this book covers the use of statistics in pharmaceutical research and clinical evaluation. It includes a disk with special prograns to aid in problem analysis. The coverage progresses from basic definitions and concepts, data graphics, and probability through ANOVA, factorial designs, and optimization techniques. The discussion and examples have been expanded to include GMPs, validation, and quality control, as well as procedures and analyses in bioequivalence studies. The text presents fresh material on concept conformity and release targets and describes linear regression and correlation, the analysis of variance, and crossover designs.

Pharmaceutical Statistics Practical and Clinical Applications Revised and Expanded 4th Table of contents:

Part I: Introduction to Pharmaceutical Statistics

  1. Introduction to Pharmaceutical Statistics

    • The role of statistics in the pharmaceutical industry
    • Key concepts and terminology in pharmaceutical statistics
    • Overview of statistical methods commonly used in pharmaceutical research and clinical trials

  2. Types of Data in Pharmaceutical Research

    • Qualitative vs. quantitative data
    • Types of measurement scales (nominal, ordinal, interval, ratio)
    • Handling and organizing pharmaceutical data for analysis

  3. Basic Statistical Tools and Techniques

    • Descriptive statistics: Mean, median, mode, range, variance, and standard deviation
    • Data visualization: Tables, histograms, and scatter plots
    • Understanding distributions and their importance in clinical data

Part II: Statistical Methods for Clinical Trials

  1. Design of Clinical Trials

    • Introduction to clinical trial phases: I, II, III, IV
    • Experimental designs: Randomized controlled trials, cohort studies, case-control studies
    • Sample size determination and power analysis

  2. Randomization and Blinding in Clinical Trials

    • The importance of randomization in clinical research
    • Types of blinding: Single, double, and triple blinding
    • Preventing bias in clinical trial designs

  3. Statistical Analysis of Clinical Trials: Hypothesis Testing

    • Null and alternative hypotheses in clinical trials
    • Type I and Type II errors
    • P-values and statistical significance

  4. Analysis of Variance (ANOVA)

    • One-way and two-way ANOVA
    • Post-hoc tests and interpretation of results
    • Applications of ANOVA in pharmaceutical clinical trials

Part III: Regression and Correlation in Pharmaceutical Research

  1. Simple Linear Regression

    • Concept and interpretation of regression analysis
    • Fitting a regression model and assessing goodness of fit
    • Applications in predicting drug efficacy or patient outcomes

  2. Multiple Regression Analysis

    • Understanding multivariable regression models
    • Interpreting coefficients and assessing model validity
    • Handling confounding variables in pharmaceutical research

  3. Correlation Analysis

    • Pearson and Spearman correlation coefficients
    • Interpreting correlations between variables
    • Applications in analyzing drug interactions and outcomes

Part IV: Advanced Statistical Methods in Pharmaceutical Statistics

  1. Survival Analysis

    • Concepts in survival analysis: Kaplan-Meier method, Cox proportional hazards model
    • Censoring and its impact on survival data
    • Applications in analyzing time-to-event data in clinical trials

  2. Meta-Analysis and Systematic Reviews

    • Fundamentals of meta-analysis: Combining results from multiple studies
    • Statistical methods for performing meta-analysis
    • Interpreting results and addressing heterogeneity

  3. Bayesian Statistics in Pharmaceutical Research

    • Introduction to Bayesian inference
    • Bayesian vs. frequentist approaches in clinical trials
    • Real-world examples of Bayesian methods in drug development

Part V: Statistical Considerations in Drug Development

  1. Pharmacokinetics and Pharmacodynamics

    • Statistical models in pharmacokinetics (PK) and pharmacodynamics (PD)
    • Estimating drug concentrations and dose-response relationships
    • Population pharmacokinetics and statistical modeling

  2. Bioequivalence and Biosimilarity Studies

    • Statistical methods for assessing bioequivalence
    • Design and analysis of bioequivalence studies
    • Regulatory considerations and statistical thresholds for bioequivalence

  3. Statistical Approaches to Safety and Adverse Events

    • Analyzing adverse event data in clinical trials
    • Signal detection and the role of statistical methods in pharmacovigilance
    • Safety monitoring and the role of interim analyses

Part VI: Regulatory and Practical Aspects

  1. Regulatory Requirements for Statistical Analysis in Pharmaceuticals

    • FDA, EMA, and ICH guidelines for statistical analysis in drug trials
    • Statistical reporting and documentation for regulatory submissions
    • Navigating challenges in regulatory approval with statistical evidence

  2. Statistical Software in Pharmaceutical Research

    • Introduction to commonly used statistical software: SAS, R, SPSS, and others
    • Best practices for using statistical software in clinical trials
    • Case studies of software applications in pharmaceutical statistics

  3. Statistical Quality Control in Pharmaceutical Manufacturing

    • Techniques for ensuring product consistency and quality control
    • Statistical process control (SPC) in pharmaceutical manufacturing
    • Regulatory standards and quality assurance using statistics

Part VII: Case Studies and Applications

  1. Case Studies in Clinical Trial Data Analysis

    • Detailed examples from real-world clinical trials
    • Step-by-step analysis of clinical trial data using statistical methods
    • Interpretation and reporting of clinical trial results

  2. Case Studies in Pharmaceutical Research

    • Applications of statistical techniques in drug development
    • Analyzing PK/PD models, safety data, and efficacy endpoints
    • Lessons learned from real-life case studies in pharmaceutical statistics

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