Bayesian analysis with R for drug development : concepts, algorithms, and case studies /: concepts, algorithms, and case studies. (2019)

• Record Type: Book
• Further Information: Note: Harry Yang and Steven J. Novick.
• Authors: Yang, Harry; Novick, Steven J
• Contents: ; SECTION I Background; ; 1. Bayesian Statistics in Pharmaceutical Development; Introduction; Overview of Drug Development; Basic Research; Drug Discovery; Formulation; Laboratory Test Methods; Pre-Clinical Studies; Clinical Development; Translational Research; Chemical Manufacturing and Control; Regulatory Registration; Statistics in Drug Research and Development; Bayesian Statistics; Opportunities of Bayesian Approach; Pre-Clinical Development; CMC Development; Clinical Trials; Challenges of Bayesian Approach; Objection to Bayesian; Regulatory Hurdles; Concluding Remarks ; 2. Basics of Bayesian Statistics ; Introduction; Statistical Inference; Research Questions; Probability Distribution; Frequentist Methods; Bayesian Inference; Selection of Priors; Bayesian Computation; Monte Carlo Simulation; Example; Markov Chain Monte Carlo; Computation Tools; BUGS and JAGS; SAS PROC MCMC; Utility of JAGS; Concluding Remarks ; 3. Bayesian Estimation of Sample Size and Power; Introduction; Sample Size Determination; Frequentist Methods; Bayesian Considerations; Bayesian Approaches; Power and Sample Size; Interim Analysis; Futility and Sample Size; Case Example; Modelling of Overall Survival; Maximum Likelihood Estimation; Futility Analysis; Concluding Remarks ; SECION II Pre-Clinical and Clinical Research; ; 4. Pre-Clinical Efficacy Study ; Introduction; Evaluation of Lab-Based Drugs in Combination; Background; Statistical Methods; Antiviral Combination; Evaluation of Fixed Dose Combination; Bayesian Survival Analysis; Limitations of Animal Data; Current Methods; Bayesian Solution; Case Example; Concluding Remarks ; 5. Bayesian Adaptive Design for Phase I Dose-Finding Studies; Introduction; Algorithm-Based Design; 3+3 Design; Alternate Algorithm-Based Designs; Advantages and Disadvantages of Algorithm-Based Designs; Model Based Designs; Continual Reassessment Methods; CRM for Phase I Cancer Trials; Escalation with Overdose Control; Escalation Based on Toxicity Intervals; Concluding Remarks ; 6. Design and Analysis of Phase II Dose-Ranging Studies; Introduction; Phase II Dose-Ranging Studies; Criticisms of Traditional Methods; Model-Based Approaches; Estimating Predictive Precision and Assurance for New Trial; COPD Study; Estimation Method; Concluding Remarks ; 7. Bayesian Multi-Stage Designs for Phase II Clinical Trials; Introduction; Phase II Clinical Trials; Multi-Stage Designs; Frequentist Approaches; Bayesian Methods; Bayesian Single-Arm Trials; Continuous Monitoring of Single-Arm Trials; Comparative Phase II Studies; Examples; Oncology Trial; Multi-Stage Bayesian Design; Concluding Remarks ; SECTION III Chemistry, Manufacturing, and Control; ; 8. Analytical Methods ; Introduction; Method Validation; Background; Study Design for Validation of Accuracy and Precision; Current Statistical Methods; Total Error Approach; Bayesian Solutions; Example; Method Transfer; Background; Model; Linear Response; Case Example; Concluding Remarks 9. Process Development ; Introduction; Quality by Design; Critical Quality Attributes; Risk of Oncogenicity; Bayesian Risk Assessment; Modeling Enzyme Cutting Efficiency; Bayesian Solution; Example; Design Space; Definition; Statistical Methods for Design Space; Bayesian Design Space; Example; Process Validation; Risk-Based Lifecycle Approach; Method Based on Process Capability; Method Based on Predictive Performance; Determination of Number of PPQ Batches; Concluding Remarks ; 10. Stability ; Introduction; Stability Study; Shelf-Life Estimation; Current Methods; Bayesian Approaches; Examples; Selection of Stability Design; Bayesian Criterion; Setting Release Limits; Concluding Remarks 11. Process Control ; Introduction; Quality Control and Improvement; Control Charts; Types of Control Charts; Shewhart I-MR Chart; EWMA Control Chart; CUSUM Control Chart; J-Chart; Multivariate Control Chart; Bayesian Control Charts; Control Chart for Data with Censoring; Control Chart for Discrete Data; Control Limit for Aberrant Data; Product Quality Control Based on Safety Data from Surveillance; Concluding Remarks ;
• Publisher Details: Boca Raton : CRC Press, Taylor & Francis Group
• Publication Date: 2019
• Extent: 1 online resource
• Subjects: 615.1/9; Drug development; Biopharmaceutics; Clinical trials; Bayesian statistical decision theory; R (Computer program language); MATHEMATICS / Probability & Statistics / General; MEDICAL / Pharmacy; MEDICAL / Biostatistics; Bayesian statistical decision theory; Biopharmaceutics; Clinical trials; Drug development; R (Computer program language); Electronic books
• Languages: English
• ISBNs: 9781315100388; 9781351585941; 1351585940; 9781351585927; 1351585924; 9781351585934; 1351585932
• Related ISBNs: 131510038X; 9781138295872
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed July 01, 2019).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.