Methodologies in biosimilar product development. (2021)

• Record Type: Book
• Further Information: Note: Edited by Sang Joon Lee and Shein-Chung Chow.
• Editors: Lee, Sang Joon; Chow, Shein-Chung, 1955-
• Contents: 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.
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2021
• Extent: 1 online resource, illustrations (black and white)
• Subjects: 615.19; Drug development; Biologicals
• Languages: English
• ISBNs: 9781000451948; 9781000451917; 9781003205807
• Related ISBNs: 9780367896348
• Notes: Note: Includes bibliographical references and index.; Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.