Methodologies in Biosimilar Product Development

ISBN-13: 9780367896348 / Angielski / Twarda / 2021 / 380 str.

Sang Joon Lee; Shein-Chung Chow

Opis

Methodologies in Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product.

Spis treści

Preface. 1. Biosimilar Product Development. 2. CMC Consideration for Quality. 3. Quality by Design. 4. Stability Studies. 5. Two One-sided Tests Versus Confidence Interval Approach. 6. Equivalence Test with Flexible Margin. 7. mQR Method for Analytical Similarity Evaluation. 8. PK/PD Bridging Studies. 9. Clinical Strategy for Non-inferiority/Similarity Margin Selection. 10: Design and Analysis of Biosimilar Switching Studies. 11: Detection of Reference Product Change. 12. Sensitivity Analysis for Assessment of Extrapolation Across Indications. 13. Design and Analysis of Non-medical Switch. 14. Case Studies. References. Subject Index.