Methodologies in biosimilar product development / edited by Sang Joon Lee, Shein-Chung Chow.
| Other author | Lee, Sang Joon. |
| Other author | Chow, Shein-Chung, 1955- |
| Format | Electronic |
| Edition | First edition. |
| Publication Info | Boca Raton : CRC Press/Taylor & Francis Group, 2022. |
| Description | xii, 380 pages: illustrations ; 24 cm |
| Supplemental Content | Full text available from Taylor & Francis eBooks |
| Subjects |
| Series | Chapman & Hall/CRC biostatistics series |
| Abstract | "Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval hypotheses testing (i.e., the use of TOST) and confidence interval approach, a risk/benefit assessment for non-inferiority/similarity margin, PK/PD bridging studies with multiple references, the detection of possible reference product change over time, design and analysis of biosimilar switching studies, the assessment of sensitivity index for assessment of extrapolation across indications without collecting data from those indications not under study, and the feasibility and validation of non-medical switch post-approval"-- Provided by publisher. |
| Bibliography note | Includes bibliographical references and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2021021525 |
| ISBN | 9780367896348 (hardback) |
| ISBN | 9781032071800 (paperback) |
| ISBN | (ebook) |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |