Analytical similarity assessment in biosimilar product development / Shein-Chung Chow, Duke University School of Medicine, Durham, North Carolina.
| Author/creator | Chow, Shein-Chung, 1955- |
| Format | Electronic |
| Publication Info | Boca Raton : CRC Press,Taylor & Francis, [2019] |
| Description | xiii, 339 pages : illustrations ; 24 cm |
| Supplemental Content | Full text available from Taylor & Francis eBooks |
| Subjects |
| Contents | Past experience for in vitro bioequivalence testing -- Regulatory approval pathway of biosimilar products -- CMC requirements -- Assay development and process validation -- Critical quality attributes -- FDA tiered approach for analytical assessment -- Sample size requirement -- Multiple references -- Extrapolation across indications -- Case studies - FDA submissions -- Practical and challenging issues -- Recent development. |
| Abstract | "Focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment"-- Provided by publisher. |
| Bibliography note | Includes bibliographical references (pages 311-319) and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| LCCN | 2018030817 |
| ISBN | 9781138307339 (hardback : alk. paper) |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |