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Analytical Similarity Assessment in Biosimilar Product Development (Hardcover) Loot Price: R4,949
Discovery Miles 49 490
Repayment Terms: R464 pm x 12*
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Analytical Similarity Assessment in Biosimilar Product Development (Hardcover): Shein-Chung Chow

Analytical Similarity Assessment in Biosimilar Product Development (Hardcover)

Shein-Chung Chow

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Loot Price R4,949 Discovery Miles 49 490 | Repayment Terms: R464 pm x 12*

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This book 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 covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

General

Imprint: Crc Press
Country of origin: United Kingdom
Release date: August 2018
First published: 2019
Authors: Shein-Chung Chow
Dimensions: 234 x 156 x 26mm (L x W x T)
Format: Hardcover
Pages: 340
ISBN-13: 978-1-138-30733-9
Categories: Books > Science & Mathematics > Biology, life sciences > General
Books > Medicine > General issues > Medical equipment & techniques > Medical research
Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics
Books > Medicine > Other branches of medicine > Pharmacology > General
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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LSN: 1-138-30733-5
Barcode: 9781138307339

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