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Methodologies in Biosimilar Product Development Loot Price: R1,501
Discovery Miles 15 010
Repayment Terms: R141 pm x 12*
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Methodologies in Biosimilar Product Development: Sangjoon Lee, Shein-Chung Chow

Methodologies in Biosimilar Product Development

Sangjoon Lee, Shein-Chung Chow

Series: Chapman & Hall/CRC Biostatistics Series

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Loot Price R1,501 Discovery Miles 15 010 | Repayment Terms: R141 pm x 12*

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Reviews withdrawn draft guidance on analytical similarity assessment.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.

General

Imprint: Taylor & Francis
Country of origin: United Kingdom
Series: Chapman & Hall/CRC Biostatistics Series
Release date: September 2023
Editors: Sangjoon Lee • Shein-Chung Chow
Dimensions: 234 x 156mm (L x W)
Pages: 380
ISBN-13: 978-1-03-207180-0
Categories: Books
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LSN: 1-03-207180-X
Barcode: 9781032071800

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