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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
£ 49.93
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
£ 54.64
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Methodologies in Biosimilar Product Development
Published by Taylor & Francis Ltd, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
Paperback / softback. Condition: New. New copy - Usually dispatched within 4 working days. 730.
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Condition: New.
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Seller: Ria Christie Collections, Uxbridge, United Kingdom
Seller rating 5 out of 5 stars
£ 57.84
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Methodologies in Biosimilar Product Development (Paperback)
Published by Taylor & Francis Ltd, London, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Paperback. Condition: new. Paperback. 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.Key Features:Reviews withdrawn draft guidance on analytical similarity assessment.Evaluates various methods for analytical similarity evaluation based on FDAs current guidelines.Provides a general approach for the use of n-of-1 trial design for assessment of interchangeability.Discusses the feasibility and validity of the non-medical switch studies.Provides innovative thinking for detection of possible reference product change over time.This book embraces innovative thinking of design and analysis for biosimilar studies, which are required for review and approval of biosimilar regulatory submissions. 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. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
£ 58.45
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
£ 58.36
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Paperback. Condition: Brand New. 392 pages. 9.19x6.13x0.89 inches. In Stock.
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
paperback. Condition: New. New. book.
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC 2021-09-24, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
Hardcover. Condition: New.
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
Condition: New.
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
Condition: As New. Unread book in perfect condition.
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
£ 141.36
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Add to baskethardcover. Condition: Fine. Open Books is a nonprofit social venture that provides literacy experiences for thousands of readers each year through inspiring programs and creative capitalization of books.
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
£ 184.18
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series) 1st Edition
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
Condition: New.
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
£ 196.44
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series) 1st Edition
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
£ 220.92
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
Seller: Ria Christie Collections, Uxbridge, United Kingdom
Seller rating 5 out of 5 stars
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series) 1st Edition
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
£ 240.71
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Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)
Published by Chapman and Hall/CRC, 2021
ISBN 10: 0367896346 ISBN 13: 9780367896348
Language: English
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Hardcover. Condition: Brand New. 440 pages. 9.00x6.25x1.00 inches. In Stock.
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Methodologies in Biosimilar Product Development
Published by Taylor and Francis Ltd, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Seller: PBShop.store UK, Fairford, GLOS, United Kingdom
Seller rating 5 out of 5 stars
£ 58.51
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Add to basketPAP. Condition: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000.
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Paperback. Condition: Brand New. 392 pages. 9.19x6.13x0.89 inches. In Stock. This item is printed on demand.
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£ 65.24
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Methodologies in Biosimilar Product Development
Published by Taylor & Francis Ltd, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
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Methodologies in Biosimilar Product Development
Published by Chapman and Hall/CRC, 2023
ISBN 10: 103207180X ISBN 13: 9781032071800
Language: English
£ 63.20
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Add to basketCondition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Sang Joon Lee, Ph.D., is a Senior Executive Vice President at Celltrion, inc. Dr. Lee was previously an assistant Professor at the University of New Mexico School of Medicine, and a Research Associate and Statistical Analyst at The Unive.
