0
Your cart

Your cart is empty

Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology

Buy Now

Methodologies in Biosimilar Product Development (Hardcover) Loot Price: R5,816
Discovery Miles 58 160
Methodologies in Biosimilar Product Development (Hardcover): Sangjoon Lee, Shein-Chung Chow

Methodologies in Biosimilar Product Development (Hardcover)

Sangjoon Lee, Shein-Chung Chow

Series: Chapman & Hall/CRC Biostatistics Series

 (sign in to rate)
Loot Price R5,816 Discovery Miles 58 160 | Repayment Terms: R545 pm x 12*

Bookmark and Share

Expected to ship within 12 - 17 working days

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 Key Features: Reviews withdrawn draft guidance on analytical similarity assessment.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.

General

Imprint: Crc Press
Country of origin: United Kingdom
Series: Chapman & Hall/CRC Biostatistics Series
Release date: September 2021
First published: 2022
Editors: Sangjoon Lee • Shein-Chung Chow
Dimensions: 234 x 156mm (L x W)
Format: Hardcover
Pages: 380
ISBN-13: 978-0-367-89634-8
Categories: Books > Science & Mathematics > Mathematics > Probability & statistics
Books > Science & Mathematics > Biology, life sciences > General
Books > Medicine > General issues > Medical equipment & techniques > Medical research
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
Promotions
LSN: 0-367-89634-6
Barcode: 9780367896348

Is the information for this product incomplete, wrong or inappropriate? Let us know about it.

Does this product have an incorrect or missing image? Send us a new image.

Is this product missing categories? Add more categories.

Review This Product

No reviews yet - be the first to create one!

You might also like..

Intelligent Materials for Controlled…
Steven M Dinh, John DeNuzzio, … Hardcover R2,518 Discovery Miles 25 180
The Biochemistry of Drug Metabolism…
B. Testa Paperback R2,468 R2,016 Discovery Miles 20 160
An Introduction to Creating Standardized…
Todd Case, Yuting Tian Hardcover R1,704 Discovery Miles 17 040
Vaccine Development - From Concept to…
A. Krishna Prasad Hardcover R5,590 Discovery Miles 55 900
Magnesium in Human Health and Disease
Sara Castiglioni, Giovanna Farruggia, … Hardcover R2,458 R2,086 Discovery Miles 20 860
Industrial Pharmacy
Ajay Semalty Hardcover R1,843 Discovery Miles 18 430
Bioequivalence study of Drug - Its…
Bhaswati Pal, Shubhasis Dan, … Hardcover R1,067 Discovery Miles 10 670
Pharmaceutical Engineering
Dulal Krishna Tripathi, Nirmalya Tripathi Hardcover R1,768 Discovery Miles 17 680
Physiologically Based Pharmacokinetic…
Sa Peters Hardcover R4,734 Discovery Miles 47 340
Pharmaceutics - Basic Principles and…
Dulal Krishna Tripathi Hardcover R1,664 Discovery Miles 16 640
Guidelines and Screening Methods of…
Surendra H Bodakhe, Parag Jain, … Hardcover R1,598 R1,379 Discovery Miles 13 790
Studies in Natural Products Chemistry…
Atta-ur Rahman Hardcover R8,766 Discovery Miles 87 660

See more

Partners