Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems

✍ Scribed by Rob Lievense

• Publisher: SAS Institute
• Year: 2018
• Tongue: English
• Leaves: 436
• Category: Library

✦ Synopsis

Solve your pharmaceutical product development and manufacturing problems using JMP®. Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries to illustrate easy-to-understand ways of incorporating QbD elements using JMP. Pharmaceutical Quality by Design Using JMP® opens by demonstrating the easy navigation of JMP to visualize data through the distribution function and the graph builder and then highlights the following:

• the powerful dynamic nature of data visualization that enables users to be able to quickly extract meaningful information
• tools and techniques designed for the use of structured, multivariate sets of experiments
• examples of complex analysis unique to healthcare products such as particle size distributions/drug dissolution, stability of drug products over time, and blend uniformity/content uniformity.

Scientists, engineers, and technicians involved throughout the pharmaceutical and medical device product life cycles will find this book invaluable.

This book is part of the SAS Press program.

✦ Table of Contents

Contents
About This Book
What Does This Book Cover?
Is This Book for You?
What Are the Prerequisites for This Book?
What Should You Know about the Examples?
Where Are the Exercise Solutions?
About the Author
We Want to Hear from You
Acknowledgments
Chapter 1: Preparing Data for Analysis
Overview
The Problem: Overfilling of Bulk Product Containers
Collect the Data
Import Data into JMP
Change the Format of a JMP Table
Explore Data with Distributions
A Second Problem: Dealing with Discrete Characteristics of Dental Implants
Get More Out of Simple Analysis with Column Formulas
Practical Conclusions
Exercises
Chapter 2: Investigating Trends in Data over Time
Overview
The Problem: Fill Amounts Vary throughout Processing
Visualize Trends over Time with Simple Plots in the Graph Builder
More Detail for Time-Based Trends with the Control Chart Builder
Dynamically Selecting Data from JMP Plots
Creating Subset Tables
Using Graph Builder to View Trends in Selected Data
Practical Conclusions
Exercises
Chapter 3: Assessing How Well a Process Performs to Specifications with Capability Analyses
Overview
The Problems: Assessing the Capability of the Fill Process and the Dental Implant Manufacturing Processes
One-Sided Capability Analysis for Fill Weight
Checking Assumptions for Fill Weight Data
Capability Studies from the Distribution Platform
Two-Sided (Bilateral) Capability Analysis for Implant Dimensions
Checking Assumptions for Implant Measures Data
Capability Analysis from the Quality and Process Options
Capability Analysis Summary Reports
Capability Analysis for Non-normal Distributions
Practical Conclusions
Exercises
Chapter 4: Using Random Samples to Estimate Results for the Commercial Population of a Process
Overview
The Problems: A Possible Difference between the Current Dissolution Results and the Historical Average
Steps for a Significance Test for a Single Mean
Importing Data and Preparing Tables for Analysis
Practical Application of a t-test for One Mean
Using a Script to Easily Repeat an Analysis
Practical Application of a Hypothesis Test for One Proportion
Practical Conclusions
Exercises
Chapter 5: Working with Two or More Groups of Variables
Overview
The Problems: Comparing Blend Uniformity and Content Uniformity, Average Flow of Medication, and Differences Between No-Drip Medications
Comparison of Two Quantitative Variables
Comparison of Two Independent Means
Unequal Variance Test
Matched Pairs Tests
More Than Two Groups
Practical Conclusions
Exercises
Chapter 6: Justifying Multivariate Experimental Designs to Leadership
Overview
The Problems: Developmental Experiments Lack Structure
Why Not One Factor at a Time?
Data Visualization to Justify Multivariate Experiments
Using the Dynamic Model Profiler to Estimate Process Performance
Practical Conclusions
Exercises
Chapter 7: Evaluating the Robustness of a Measurement System
Overview
The Problems: Determining Precision and Accuracy for Measurements of Dental Implant Physical Features
Qualification of Measurement Systems through Simple Replication
Analysis of Means (ANOM) for Variances of Measured Replicates
Measurement Systems Analysis (MSA)
Detailed Diagnostics of Measurement Systems through MSA Options
Variability and Attribute Charts for Measurement Systems
Practical Conclusions
Exercises
Chapter 8: Using Predictive Models to Reduce the Number of Process Inputs for Further Study
Overview
The Problem: Thin Surgical Handle Covers
Data Visualization with Dynamic Distribution Plots
Basic Partitioning
Partitioning with Cross Validation
Partitioning with Validation (JMP Pro Only)
Stepwise Model Selection
Practical Conclusions
Exercises
Chapter 9: Designing a Set of Structured, Multivariate Experiments for Materials
Overview
The Problem: Designing a Formulation Materials Set of Experiments
The Plan
Using the Custom Designer
Using Model Diagnostics to Evaluate Designs
Compare Designs – An Easy Way to Compare Up to Three Designs (JMP Pro Only)
The Data Collection Plan
Augmenting a Design
Practical Conclusions
Exercises
Chapter 10: Using Structured Experiments for Learning about a Manufacturing Process
Overview
The Problems: A Thermoforming Process and a Granulation Process, Each in Need of Improvement
Screening Experimental Designs for the Thermoforming Process
Compare Designs for Main Effects with Different Structures (JMP Pro Only)
Adding Interactions to Compare Designs (JMP Pro Only)
Visualizing Design Space with Scatterplot Matrices
Experimental Design for a Granulation Process with Multiple Outputs
Practical Conclusions
Exercises
Chapter 11: Analysis of Experimental Results
Overview
The Problems: A Thermoforming Process and a Granulation Process, Each in Need of Improvement
Execution of Experimental Designs
Analysis of a Screening Design
Detailed Analysis of the DSD Model
Use of the Fit Model Analysis Menu Option
Singularity
Analysis of a Partially Reduced Model
Analysis of a Response Surface Model with Multiple Outputs
Examination of Fit Statistics for Individual Models
Model Diagnostics through Residual Analysis
Parameter Estimates
Detailed Analyses of Significant Factors with Leverage Plots
Visualization of the Higher-Order Terms with the Interaction Plots
Examination of an Insignificant Model
Dynamic Visualization of a Design Space with the Prediction Profiler
Elimination of Insignificant Models to Enhance Interpretation
Practical Conclusions
Exercises
Chapter 12: Getting Practical Value from Structured Experiments
Overview
The Problems: Statistical Modeling Are Needed to Gain Detail About A Thermoforming Process and a Granulation Process
Identification of a Control Space from the Thermoforming DSD
Verification of a Control Space with Individual Interval Estimates
Using Simulations to Model Input Variability for a Granulation RSM
Including Variations in Responses Within RSM Simulations
Making Detailed Practical Estimations of Process Performance with a Table of Simulated Modeling Data
Creating a PowerPoint Presentation from JMP Results
Practical Conclusions
Exercises
Chapter 13: Advanced Modeling Techniques
Overview
The Problem: A Shift in Tablet Dissolution
Preparing a Data Table to Enhance Modeling Efficiency
Partition Modeling
Stepwise Models
Neural Network Models
Advanced Predictive Modeling Techniques (Bootstrap Forest) (JMP Pro Only)
Model Comparison (JMP Pro only)
Practical Conclusions
Exercises
Chapter 14: Basic Mixture Designs for Materials Experiments
Overview
The Problem: Precipitants in a Liquid Drug Solution
Design of Mixture Experiments
Ternary Plots for Model Diagnosis
Analysis of Mixture Design Results
Model Profiler
The Practical Application of Profiler Optimization
Practical Conclusions
Exercises
Chapter 15: Analyzing Data with Non-linear Trends
Overview
The Problems: Comparing Drug Dissolution Profiles and Comparing Particle Size Distributions
Formatting Data for Non-linear Modeling
Making a Simple Plot of Dissolution Profiles
Creating a Non-linear Model of Dissolution Profiles
Equivalence Testing of Dissolution Profiles
Comparisons of Dissolution Profiles with the F2 Similarity Criterion
Making F2 Similarity Predictive
Using Non-linear Models for Mesh Testing of Particle-Size Trends
Augmenting Non-linear Plots by Using Axis Settings
Making Predictions with Non-linear Models
Practical Conclusions
Exercises
Chapter 16: Using Statistics to Support Analytical Method Development
Overview
The Problem: A Robust Test Method Must Be Developed
Experimental Planning
Design Creation Using the Definitive Screening Design (DSD)
Model Analysis of the DSD
Making Estimates from the Model
Using Simulations to Estimate Practical Results
Practical Conclusions
Exercises
Chapter 17: Exploring Stability Studies with JMP
Overview
The Problem: Transdermal Patch Stability
Summarizing Stability Data
Adding Initial Results and Formatting for Stability Studies
Running Stability Analysis
Stability—Linear Model Diagnostics
Using Stability Estimates to Calculate Internal Limits
Practical Conclusions
Exercises
References