Keith M. Bower | BioProcess International

Keith M. Bower

Latest from Keith M. Bower

Appropriate Estimation of Long-Term Variability: Using Biopharmaceutical Release and Stability Data

Information Technology

Appropriate Estimation of Long-Term Variability: Using Biopharmaceutical Release and Stability Data Appropriate Estimation of Long-Term Variability: Using Biopharmaceutical Release and Stability Data

byKeith M. Bower

Sep 28, 2022

Using Prior Knowledge to Estimate Long-Term Variation

Process Monitoring and Controls

Using Prior Knowledge to Estimate Long-Term Variation Using Prior Knowledge to Estimate Long-Term Variation

byKeith M. Bower

Mar 9, 2021

All from Keith M. Bower

Practical Considerations for Statistical Analyses in Continued Process Verification

Process Monitoring and Controls

Practical Considerations for Statistical Analyses in Continued Process Verification

Practical Considerations for Statistical Analyses in Continued Process Verification

byKeith M. Bower

Run Rules with Autocorrelated Data for Continued Process Verification

Continuous Bioprocessing

Run Rules with Autocorrelated Data for Continued Process Verification

Run Rules with Autocorrelated Data for Continued Process Verification

byKeith M. Bower

Biopharmaceutical Product Specification Limits and Autocorrelated Data

Product Characterization

Biopharmaceutical Product Specification Limits and Autocorrelated Data

Biopharmaceutical Product Specification Limits and Autocorrelated Data

byKeith M. Bower

Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data

Process Monitoring and Controls

Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data

Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data

byKeith M. Bower

Certain Approaches to Understanding Sources of Bioassay Variability

Certain Approaches to Understanding Sources of Bioassay Variability

Certain Approaches to Understanding Sources of Bioassay Variability

byKeith M. Bower

Statistical Assessments of Bioassay Validation Acceptance Criteria

Statistical Assessments of Bioassay Validation Acceptance Criteria

Statistical Assessments of Bioassay Validation Acceptance Criteria

byKeith M. Bower

The Relationship Between R<sup>2</sup> and Precision in Bioassay Validation

The Relationship Between R2 and Precision in Bioassay Validation

The Relationship Between R2 and Precision in Bioassay Validation

byKeith M. Bower

A Statistical Approach to Assess and Justify Potential Product Specifications

A Statistical Approach to Assess and Justify Potential Product Specifications

A Statistical Approach to Assess and Justify Potential Product Specifications

byTodd Coffey, PhD, Keith M. Bower

Subscribe to receive our monthly print or digital publication

Join our 70,000+ readers. And yes, it's completely free.