Intro; Contents; Contributors; Specification and Sampling Acceptance Tests; Statistical Considerations in Setting Quality Specification Limits Using Quality Data; 1 Introduction; 2 Statistical Methods for Setting Specification Criteria; 3 Relationships Between Coverage and k of PI, RI and TI; 4 Specification Determined with Pre-marketing Data; 5 Specification Determined Updated with Post-marketing Data; 6 Conclusions and Discussion; References; Counting Test and Parametric Two One-Sided Tolerance Interval Test for Content Uniformity Using Large Sample Sizes; 1 Introduction; 2 Sampling Tests

3 Monte Carlo Simulation Method4 Comparison of Acceptance Probabilities Between EU Option 2 and PTIT_matchUSP90; 4.1 Comparison of PTIT_matchUSP90 with EU Option 2 for Normal Variables with 100% LC Mean when n = 1000; 4.2 Comparison of PTIT_matchUSP90 with EU Option 2 for Normal Variables with 102% LC Mean when n = 1000; 4.3 Comparison of PTIT_matchUSP90 with EU Option 2 for a Mixture of Two Normal Variables with off Target Mean When n = 1000; 4.4 Comparison of PTIT_matchUSP90 with EU Option 2 for Three Extreme Cases; 5 Discussion and Conclusion; References

Analytical Biosimilar and Process ValidationSample Size Consideration for Equivalent Test of Tier-1 Quality Attributes for Analytical Biosimilarity Assessment; 1 Introduction; 2 Sample Size Requirement for the Equivalence Testing for a Single Tier 1 Quality Attribute; 3 Sample Size Requirement for the Equivalence Testings for Two Correlated Tier 1 Quality Attributes; 4 Discussion and Comments; Appendix; References; A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study; 1 Introduction

2 HPLC-NIR Calibration During Process Design3 Relative Performance Index; 4 Method Comparison Using the Relative Performance Index; 5 Case Study; 5.1 Data Description; 5.2 Statistical Model and Results; 6 Summary; References; A Further Look at the Current Equivalence Test for Analytical Similarity Assessment; 1 Introduction; 2 FDA's Tiered Approach for Analytical Similarity Assessment; 3 Assessment of the FDA Recommended Equivalence Test for Tier 1 QAs; 3.1 The Impact of SR Estimate on the Type I Error and the Power; 3.2 The Unbalanced Sample Size; 4 Summary

Appendix 1 The Asymptotic Approximation to the Type I Error Rate for the Statistical Equivalence TestReferences; Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large Molecules; 1 Introduction; 2 Sample Size Calculation Methods; 2.1 For Continuous CQAs with Acceptance Limits; 2.2 For Binary CQAs; 2.3 Illustration and Examples; 2.4 SSNormTI; 2.5 VarCompLM; 2.6 RiskBinom; 3 Discussion; References; Continuous Process; Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian Approach; 1 Introduction