| Description |
1 online resource |
| Contents |
Machine generated contents note: 1.1. Background / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.2. Biopharmaceutical Development / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.3. Statistics in Bioprocess Development / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4. Statistical Inferences / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.1. Example / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.2. Random Variables / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.3. Continuous Distributions / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.3.1. Gaussian Distribution / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.3.2. Student's t-Distribution / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.3.3. Chi-Square Distribution / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.3.4. F-Distribution / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.4. Discrete Distributions / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.4.1. Binomial / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.4.4.2. Poisson / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.5. Sampling Considerations / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.5.1. Non-Random Sample / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.5.2. Simple Random Sampling / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.5.3. Stratified Sampling / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.5.4. Systematic Sampling / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.6. Statistical Estimation / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.6.1. Point Estimate / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.6.2. Interval Estimation / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.6.2.1. Confidence Interval / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.6.2.2. Prediction Interval / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.6.2.3. Tolerance Interval / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7. Hypothesis Testing / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7.1. Type I and Type II Errors / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7.2. Significance Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7.3. Statistical Significance / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7.4. Equivalence Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7.4.1. Issues with Significance Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.7.4.2. Alternate Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.8. Sample Size / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.8.1. Sample Size for Estimation / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.8.2. Sample Size for Significance Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.8.3. Sample Size for Equivalence Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.9. Selection of Method for Data Analysis / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.9.1. Example / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.9.2. Test Model Assumptions / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.9.2.1. Q-Q Plot / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.9.2.2. Nonparametric Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.9.3. Data Transformation / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10. Removal of Outliers / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10.1. Definition / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10.2. Outlier Tests / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10.2.1. Grubbs' Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10.2.2. Dixon's Test / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10.2.3. Other Outlier Tests / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.10.2.4. Model-Based Method / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.11. Bayesian Inference / Harry Yang / Steven J. Novick / Lorin Roskos -- 1.12. Concluding Remarks / Harry Yang / Steven J. Novick / Lorin Roskos -- References / Harry Yang / Steven J. Novick / Lorin Roskos -- 2.1. Introduction and Overview / Todd Coffey -- 2.1.1. Definitions / Todd Coffey -- 2.1.2. General Classes of Designs / Todd Coffey -- 2.2. Before You Start: Planning for Success / Todd Coffey -- 2.2.1. Defining the Experimental Purpose / Todd Coffey -- 2.2.2. Selecting the Responses / Todd Coffey -- 2.2.3. Identifying Factors, Levels, and Ranges / Todd Coffey -- 2.2.4. Fundamental Design Principles / Todd Coffey -- 2.3. Design Building Blocks / Todd Coffey -- 2.3.1. Design Notation / Todd Coffey -- 2.3.2. Factorial Designs / Todd Coffey -- 2.3.3. 2k-p Fractional Factorial Designs / Todd Coffey -- 2.4. Choosing a Design / Todd Coffey -- 2.4.1. Screening Experiments / Todd Coffey -- 2.4.2. Characterization Experiments / Todd Coffey -- 2.4.3. Optimization Experiments / Todd Coffey -- 2.4.4. Advantages and Disadvantages of the Classical Approach / Todd Coffey -- 2.5. Analyzing a Single Response / Todd Coffey -- 2.5.1. Linear Regression Fundamentals / Todd Coffey -- 2.5.2. Linear Regression Model / Todd Coffey -- 2.5.3. Model Fitting / Todd Coffey -- 2.5.4. Model Assumptions / Todd Coffey -- 2.5.5. Statistical Analysis for Screening Experiments / Todd Coffey -- 2.5.6. Statistical Analysis for Characterization Experiments / Todd Coffey -- 2.5.7. Statistical Analysis for Optimization Experiments / Todd Coffey -- 2.6. Analyzing Multiple Responses Simultaneously / Todd Coffey -- 2.7. Summary / Todd Coffey -- References / Todd Coffey -- 3.1. Introduction / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2. Design Space Definition and Visualization / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.1. Quality Target Product Profile and Critical Quality Attributes / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.2. Critical Process Parameters / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.3. Design of Experiments / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.4. Model / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.5. Probability of Success / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.6. Visualization of the Results / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.7. Determining and Reporting the Design Space / Perceval Sondag / Pierre Lebrun / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.8. Design Space vs. PAR / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.2.9. Illustration / Perceval Sondag / Pierre Lebrun / Xavier Lories / Bruno Boulanger / Eric Rozet / Jean-Francois Michiels -- 3.3. Example / Pierre Lebrun / Perceval Sondag / Xavier Lories / Jean-Francois Michiels / Eric Rozet / Bruno Boulanger -- 3.4. Conclusion / Pierre Lebrun / Perceval Sondag / Eric Rozet / Jean-Francois Michiels / Xavier Lories / Bruno Boulanger -- References / Bruno Boulanger / Jean-Francois Michiels / Eric Rozet / Pierre Lebrun / Perceval Sondag / Xavier Lories -- 4.1. Introduction / Richard K |
|
Burdick -- 4.1.1. Description of an Analytical Procedure / Richard K. Burdick -- 4.1.2. Description of Life Cycle Approach / Richard K. Burdick -- 4.1.3. Measurement Error Models / Richard K. Burdick -- 4.2. Stage 1: Procedure Design / Richard K. Burdick -- 4.3. Stage 2: Procedure Performance Qualification / Richard K. Burdick -- 4.3.1. Individual Qualification for Accuracy and Precision / Richard K. Burdick -- 4.3.2. Incorporation of a Ruggedness Factor / Richard K. Burdick -- 4.3.3. Power Considerations / Richard K. Burdick -- 4.3.4. Holistic Qualification of a Bioassay Method / Richard K. Burdick -- 4.3.5. Holistic Qualification of a Relative Purity Method / Richard K. Burdick -- 4.3.6. Limit of Detection (LOD) and Linearity / Richard K. Burdick -- 4.4. Step 3: Continued Procedure Performance Verification / Richard K. Burdick -- References / Richard K. Burdick -- 5.1. Introduction / David Lansky -- 5.1.1. Supporting a Biotechnology Product / David Lansky -- 5.1.2. Product Specifications Ensure Efficacy and Safety / David Lansky -- 5.2. Statistical and Strategic Introduction / David Lansky -- 5.2.1. Common Properties of Bioassays / David Lansky -- 5.2.2. Issues with Common Analysis Strategies / David Lansky -- 5.3. Recommended Bioassay Analysis Strategy / David Lansky -- 5.3.1. Transformation / David Lansky -- 5.3.2. Outlier Management / David Lansky -- 5.3.3. Assay Acceptance Criteria / David Lansky -- 5.3.4. Mixed Models / David Lansky -- 5.3.5. Equivalence Testing for Similarity / David Lansky -- 5.3.6. Model Selection / David Lansky -- 5.3.7. Bioassay Analysis Summary / David Lansky -- 5.4. Strategic Design / David Lansky -- 5.4.1. Design Goals / David Lansky -- 5.4.2. Practical and Strategic Design Constraints / David Lansky -- 5.4.3. Other Bioassay Design Considerations / David Lansky |
|
Note continued: 5.4.4. Design Strategies during Bioassay Development / David Lansky -- 5.5. Other Ways to Be Strategic by Combining Design, Analysis, and Use of Bioassays / David Lansky -- 5.6. Qualification/Validation Experiment Design and Analysis / David Lansky -- 5.6.1. Discussion of the Qualification Experiment Results / David Lansky -- 5.7. Summary / David Lansky -- References / David Lansky -- 6.1. Regulatory Requirements / Harry Yang -- 6.2. Identification of Critical Quality Attributes / Harry Yang -- 6.3. Selection of Critical Process Parameters and Input Material Attributes / Harry Yang -- 6.4. Control Strategies / Harry Yang -- 6.4.1. Input Material Control / Harry Yang -- 6.4.2. In-Process Control / Harry Yang -- 6.4.2.1. Procedural Controls / Harry Yang -- 6.4.2.2. Process Parameter Controls / Harry Yang -- 6.4.2.3. In-Process Testing / Harry Yang -- 6.4.3. Release Testing / Harry Yang -- 6.4.4. Stability Trending / Harry Yang -- 6.4.5. Comparability Testing / Harry Yang -- 6.4.6. Continuous Process Verification / Harry Yang -- 6.5. Considerations in Setting Acceptance Criteria / Harry Yang -- 6.5.1. Frame of Reference / Harry Yang -- 6.5.2. Sources of Variation / Harry Yang -- 6.5.3. Impact of Correlation / Harry Yang -- 6.5.4. Clinical Relevance Limits / Harry Yang -- 6.5.5. Shelf Life / Harry Yang -- 6.5.6. Release Limit / Harry Yang -- 6.5.6.1. Fixed Effect Model / Harry Yang -- 6.6. Multivariate Specifications / Harry Yang -- 6.7. Concluding Remarks / Harry Yang -- References / Harry Yang -- 7.1. Introduction / Laura D. Pack -- 7.2. Word about Study Design / Laura D. Pack -- 7.3. Word about Source Data / Laura D. Pack -- 7.4. Stability Models for Use in This Chapter / Laura D. Pack -- 7.4.1. Fixed Lot Model / Laura D. Pack -- 7.4.1.1. Statistical Assumptions for the Fixed Lot Model / Laura D. Pack -- 7.4.1.2. Fitting the Fixed Lot Model in JMP® / Laura D. Pack -- 7.4.1.3. Obtaining Output from the Fixed Lot Model Fit in JMP® / Laura D. Pack -- 7.4.1.4. Verifying Statistical Assumptions for the Fixed Lot Model in MP® / Laura D. Pack -- 7.4.2. Random Lot Model / Laura D. Pack -- 7.4.2.1. Statistical Assumptions for the Random Lot Model / Laura D. Pack -- 7.4.2.2. Fitting the Random Lot Model in JMP® / Laura D. Pack -- 7.4.2.3. Obtaining Output from the Random Lot Model Fit in JMP® / Laura D. Pack -- 7.4.2.4. Verifying Statistical Assumptions for the Random Lot Model in JMP® / Laura D. Pack -- 7.4.3. Qualitative Predictor Model / Laura D. Pack -- 7.4.3.1. Statistical Assumptions for the Qualitative Predictor Model / Laura D. Pack -- 7.4.3.2. Fitting the Qualitative Predictor Model in JMP® / Laura D. Pack -- 7.4.3.3. Obtaining Output from the Qualitative Predictor Model Fit in JMP® / Laura D. Pack -- 7.4.3.4. Verifying Statistical Assumptions in JMP® / Laura D. Pack -- 7.5. Outline / Laura D. Pack -- 7.6. Is There a Trend on Stability? / Laura D. Pack -- 7.6.1. Can a Particular CQA Be Considered "Stability Indicating"? / Laura D. Pack -- 7.6.2. Is the Change over Time Statistically Significant? / Laura D. Pack -- 7.6.3. Is the Change over Time Practically Significant? / Laura D. Pack -- 7.6.4. Is an Individual Result in Trend? / Laura D. Pack -- 7.6.5. Is a Stability Lot in Trend? / Laura D. Pack -- 7.6.6. How Can I Establish a Stability Trending Program? / Laura D. Pack -- 7.6.7. How Can I Perform an Annual "Trend Analysis" as Required for Commercially Approved Products? / Laura D. Pack -- 7.7. How Is the Stability Profile Related to the Expiry Period? / Laura D. Pack -- 7.7.1. What Is the Appropriate Expiry or Retest Period for My Product? / Laura D. Pack -- 7.7.2. Will an Individual Lot Meet Its Intended Expiry Period? / Laura D. Pack -- 7.7.3. Can I Extend the Expiry Period? / Laura D. Pack -- 7.7.4. How Can I Model Behavior for End-to-End Stability for Multiple Product Stages? / Laura D. Pack -- 7.8. How Does the Stability Profile Relate to the Specification Limit? / Laura D. Pack -- 7.8.1. What Is the Appropriate Specification Limit to Achieve a Desired Expiry or Retest Period? / Laura D. Pack -- 7.8.2. Is It Appropriate to Have a Tighter Specification Limit at Lot Release? / Laura D. Pack -- 7.8.3. Does Changing the Specification Limit Impact the Expiry? / Laura D. Pack -- 7.8.4. What Is the Probability of an Individual 00S Result on Stability? / Laura D. Pack -- 7.9. How Much Exposure to a Particular Condition Can Be Allowed without Impacting the Shelf Life? / Laura D. Pack -- 7.9.1. What Is an Appropriate Limit for Exposure to Temperatures above Recommended Storage? / Laura D. Pack -- 7.9.2. How Much Light Exposure Is Acceptable? / Laura D. Pack -- 7.9.3. Does Temperature Cycling Impact My Product? / Laura D. Pack -- 7.10. Do Two (Or More) Different Permutations of My Molecule Change the Same Way over Time? / Laura D. Pack -- 7.10.1. Can I Apply a Bracketing Approach to Several Different Configurations of the Same Product Formulation? / Laura D. Pack -- 7.10.2. Is One Formulation, Container, or Configuration More Stable at a Given Temperature? / Laura D. Pack -- 7.10.3. Is the Stability Profile the Same after a Manufacturing or Process Change? / Laura D. Pack -- 7.11. Conclusion / Laura D. Pack -- References / Laura D |
|
Pack -- 8.1. Introduction / Tara Scherder / Katherine Giacoletti -- 8.2. Statistical Tools for CPV / Tara Scherder / Katherine Giacoletti -- 8.2.1. SPC Phases, Control Charts and Process Monitoring / Tara Scherder / Katherine Giacoletti -- 8.2.2. Shewhart Control Chart for Individual Measurements / Tara Scherder / Katherine Giacoletti -- 8.2.3. Process Capability / Tara Scherder / Katherine Giacoletti -- 8.3. Special Considerations for CPV in the Biopharmaceutical Industry / Tara Scherder / Katherine Giacoletti -- 8.3.1. Randomness, Independence, and Normality-Lack Thereof / Tara Scherder / Katherine Giacoletti -- 8.4. Business Considerations for Implementation of CPV / Tara Scherder / Katherine Giacoletti -- 8.5. Other Control Charts / Tara Scherder / Katherine Giacoletti -- References / Tara Scherder / Katherine Giacoletti -- 9.1. Background / Jianchun Zhang / Harry Yang -- 9.2. Multivariate Analysis / Jianchun Zhang / Harry Yang -- 9.2.1. Multiple Regression / Jianchun Zhang / Harry Yang -- 9.2.1.1. Overlapping Response Surfaces / Jianchun Zhang / Harry Yang -- 9.2.1.2. Desirability Approach / Jianchun Zhang / Harry Yang -- 9.2.1.3. Bayesian Approach / Jianchun Zhang / Harry Yang -- 9.2.2. PCA / Jianchun Zhang / Harry Yang -- 9.2.3. PLS / Jianchun Zhang / Harry Yang -- 9.3. Multivariate Process Control / Jianchun Zhang / Harry Yang -- 9.3.1. Process Control / Jianchun Zhang / Harry Yang -- 9.3.2. Batch Process Monitoring / Jianchun Zhang / Harry Yang -- 9.4. Applications / Jianchun Zhang / Harry Yang -- 9.4.1. Operating Ranges of Chromatography Assay / Jianchun Zhang / Harry Yang -- 9.4.2. Optimization of Cell Culture System / Jianchun Zhang / Harry Yang -- 9.4.3. Quantification of Scale-Down Model for Bioreactor / Jianchun Zhang / Harry Yang -- 9.4.4. PCA-Based Process Control / Jianchun Zhang / Harry Yang -- 9.5. Concluding Remarks / Jianchun Zhang / Harry Yang -- References / Jianchun Zhang / Harry Yang -- 10.1. Introduction / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.2. Common Steps of a Robustness Assessment / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.3. Design of Experiments / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.4. Evaluation of Assay Robustness / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.4.1. Graphical Evaluation by Half-Normal Plot / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.4.2. Dong's Method / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.4.3. Linear Model / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.4.4. Statistical vs. Practical Significance / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.5. Case Study / Binbing Yu / Lingmin Zeng / Harry Yang -- 10.6. Discussions / Binbing Yu / Lingmin Zeng / Harry Yang -- References / Binbing Yu / Lingmin Zeng / Harry Yang -- 11.1. Regulatory Guidance / Harry Yang -- 11.2. Risk-Based Sampling Plans / Harry Yang -- 11.3. Applications / Harry Yang -- 11.3.1. Raw Material, Drug Substance, and Finished Product Release / Harry Yang -- 11.3.2. Process Efficiency / Harry Yang -- 11.3.3. Environmental Monitoring / Harry Yang -- 11.3.4. Stability Testing / Harry Yang -- 11.4. Acceptance Sampling for Lot Inspection / Harry Yang -- 11.4.1. Acceptance Sampling Plan / Harry Yang -- 11.4.2. Quality Level / Harry Yang -- 11.4.3. Operating Characteristic Curve / Harry Yang -- 11.4.4. Single Attribute Sampling / Harry Yang -- 11.4.5. Variables Sampling / Harry Yang -- 11.4.6. Selection of Sampling Plan / Harry Yang -- 11.4.7. Double Sampling Plan / Harry Yang -- 11.5. Acceptance Sampling of Liquid Product / Harry Yang -- 11.5.1. Prefiltration Bioburden Control / Harry Yang -- 11.5.2. Performance of Prefiltration Test Procedures / Harry Yang -- 11.5.3. Risk Mitigation through Sterile Filtration / Harry Yang -- 11.6. Sampling for Stability Testing / Harry Yang -- 11.7. Sampling and Environmental Monitoring / Harry Yang -- 11.7.1. Sampling Site, Timing, and Frequency / Harry Yang -- 11.7.2. Alert and Action Limits / Harry Yang -- 11.8. Concluding Remarks / Harry Yang -- References / Harry Yang |
| Summary |
"The use of statistics in process development is increasing throughout the biotechnology industry, due in part to an FDA mandate demanding the increased use of statistical concepts, the recognition of the importance of statistics, and the availability of powerful and user-friendly software. This book gives an overview of statistical methods for biotechnology process development, with an emphasis on application and minimal theoretical details. Examples using real data and case studies with JMP software are used throughout to illustrate topics."--Provided by publisher |
| Notes |
"A Chapman & Hall book." |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Description based on print version record |
| Subject |
Biotechnology -- Data processing
|
|
SCIENCE -- Chemistry -- Industrial & Technical.
|
|
TECHNOLOGY & ENGINEERING -- Chemical & Biochemical.
|
|
Biotechnology -- Data processing
|
| Form |
Electronic book
|
| Author |
Coffey, Todd, editor
|
|
Yang, Harry, editor
|
| LC no. |
2020691425 |
| ISBN |
9781351646345 |
|
1351646346 |
|
9781498721417 |
|
1498721419 |
|
9781315120034 |
|
1315120038 |
|
9781351636803 |
|
1351636804 |
|
