Methodologies in Biosimilar Product Development

Language: English

Published by Chapman And Hall/CRC, 2023

103207180X / 9781032071800

Series: Book 126 of 155 - Chapman & Hall/CRC Biostatistics

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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nach der Bestellung gedruckt Neuware - Printed after ordering - 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not under study, and the feasibility and validation of non-medical switch post-approval.Key Features:Reviews withdrawn draft guidance on analytical similarity assessment.Evaluates various methods for analytical similarity evaluation based on FDA's current guidelines.Provides a general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.…

Seller Inventory # 9781032071800

Title
Methodologies in Biosimilar Product Development
Author
Shein-Chung Chow
Publisher
Chapman And Hall/CRC
Publication year
2023
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
103207180X
ISBN 13
9781032071800
Item weight
597 grams
Dimensions
234x156x21 mm
Series
Book 126 of 155: Chapman & Hall/CRC Biostatistics

AHA-BUCH GmbH

Einbeck, Germany

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