Mathematical and statistical skills in the biopharmaceutical industry : a pragmatic approach /: a pragmatic approach. (2019)

• Record Type: Book
• Further Information: Note: Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce.
• Authors: Pitman, Arkadiy; Sverdlov, Oleksandr; Pearce, L. Bruce
• Contents: 1. Background and Motivation Pragmatic approach to problem solving; Problem solving skills Mathematics versus statistics A look at the modern drug development Stages of drug development Factors that have had an impact on drug development Statistics and evidence-based science In summary: what this book is all about Introduction to Chapters 2, 3, and 4 2 Statistical Programming Introduction Asking the right questions Choice of statistical and presentation software \95/5" rule The sources SAS Certification | Is it worth time and efforts? Data access, data creation and data storage Getting data from external files Data handling The DATA step Loops and arrays Going from vertical to horizontal datasets and vice versa Why do we need basic knowledge of the Macro language? Open code vs. DATA step Loops in the open code (inside macros) and nested macros Use of pre-written (by others) macro code Summary 3 Data Management Introduction Design of data collection Organization of data collection Data cleaning or verification Re-structuring of the data First case study Second case study Summary 4 Biostatistics Introduction The biostatistician's role Background assessment: what do we start with? A minimal sufficient set of tools for the biostatistician Knowledge of the disease area Knowledge of the regulatory landscape Understanding of the clinical trial protocol Knowledge of statistical methodologies for protocol development Statistical software Communication skills Knowledge of processes Advanced biostatistics toolkit Adaptive designs Basket, umbrella, platform trials and master protocols Dose-finding methods Multiplicity issues Estimands Quantitative decision-making support Digital development Summary Introduction to Chapters 5, 6, and 7 5 Development of New Validated Scoring Systems Introduction Recognition of problem existence Study of available methods and tools with consequent realization that they are insufficient Clear formulation and formalization of the main task to be solved A solution itself Are we finished? Not in the regulatory setting! Assessment of created by-products as potentially new tools, skills and methods Generalization of all achievements and evaluation of potential applications in real world 6 Resurrecting a Failed Clinical Program Preamble: what we are dealing with Problems solved Studying drugs with dosage that depends on needs Separation of toxicity and efficacy effects in safety outcome misbalance Creation of a PK model for the transfusion field Mystery of the transfusion trigger The rise and fall of the HBOC field Summary 7 Can One Predict Unpredictable? Personal disclaimer/preamble First, what can we do? Problems in planning of the open-ended projects Extraneous vs. overlooked parts in preliminary planning Level of uncertainty of elementary tasks Terminology and definitions Estimating distribution of time to completion of an open-ended project Surprising results of first test runs of the algorithm The nature of estimates for elementary tasks Estimation for a single branch How to analyze the results? Summary Appendix A: Relativistic and Probabilistic Functions Appendix B: Manual for Successful Crusade in Defence of Patients' Rights Afterword Final Remark Bibliography
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615.1401513; Pharmacy -- Statistical methods; Pharmaceutical industry -- Statistical methods; Drugs -- Testing -- Statistical methods
• Languages: English
• ISBNs: 9780429532238; 9781498769808; 9780429546938; 9780429155352
• Related ISBNs: 9781498769792
• Notes: Note: Includes bibliographical references.; Note: Description based on CIP data; resource not viewed.
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