Biosimilars
Design and Analysis of Follow-on Biologics
This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies under various study designs at various stages of research and development of biologic products--
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Produktdetails
- ISBN: 978-1-4665-7969-9
- EAN: 9781466579699
- Produktnummer: 20650739
- Verlag: Taylor and Francis
- Sprache: Englisch
- Erscheinungsjahr: 2013
- Seitenangabe: 444 S.
- Masse: H23.4 cm x B15.6 cm 980 g
- Abbildungen: Farb., s/w. Abb.
- Gewicht: 980
Über den Autor
Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also a professor of clinical sciences at Duke-National University of Singapore Graduate Medical School. He is the editor-in-chief of the Journal of Biopharmaceutical Statistics and editor-in-chief of the Chapman & Hall/CRC Biostatistics Series. He has authored or co-authored over 230 papers and 22 books, including Adaptive Design Methods in Clinical Trials, Second Edition, Handbook of Adaptive Designs in Pharmaceutical and Clinical Development, and Controversial Statistical Issues in Clinical Trials. A fellow of the ASA and member of the ISI, Dr. Chow has received the ASA Chapter Service Recognition Award, the DIA Outstanding Service Award, and the ICSA Extraordinary Achievement Award.
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