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Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics

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Analytical Similarity Assessment in Biosimilar Product Development (Hardcover) Loot Price: R5,369

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Repayment Terms: R503 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 R5,369 Discovery Miles 53 690 | Repayment Terms: R503 pm x 12*

Expected to ship within 12 - 19 working days

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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 Promotions
LSN:	1-138-30733-5
Barcode:	9781138307339