Analytical Similarity Assessment in Biosimilar Product Development - Image 1

£161.72

CRC Press Analytical Similarity Assessment in Biosimilar Product Development

Name: Analytical Similarity Assessment in Biosimilar Product Development
Brand: CRC Press
Price: 161.72 GBP
Availability: InStock

Pharmacy - Dispensing

This is the most expensive it has ever been. Walk away.

£162 today · previous high £162 · all-time low £119

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↓ Price chart
when this has been cheap or pricey

↓ Forecast
where the price is heading next

↓ Statistics
all-time high & low, recent range

↑ Price alert
name your number, we'll email you

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 640 days • 640 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 640 days • 9 price levels

Days at Price

Current Price

Price Analysis

Most common price: £145 (217 days, 33.9%)

Price range: £119 - £162

Price levels: 9 different prices over 640 days

Description

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. About the Author Author Shein-Chung Chow, Ph.D, is currently an Associate Director at Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Prior to joining FDA, Dr. Chow was a Professor at Duke University School of Medicine, Durham, NC. He was also a special government employee (SGE) appointed by the FDA as an Advisory Committee member and statistical advisor to the FDA. Prior to that, Dr. Chow also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press, Taylor & Francis Group. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is the author or co-author of over 300 methodology papers and 29 books including Designs and Analysis of Bioavailability and Bioequivalence Studies, Sample Size Calculations in Clinical Research, Adaptive Design Methods in Clinical Trials, Translational Medicine, Design and Analysis of Clinical Trials, and Quantitative Methods for Traditional Chinese Medicine Development.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1138307335
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Pharmacy - Dispensing
Domain: Amazon UK
Release Date: 01 August 2018
Listed Since: 20 June 2018

Barcode

No barcode data available

CRC Press Analytical Similarity Assessment in Biosimilar Product Development

This is the most expensive it has ever been. Walk away.

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Methodologies in Biosimilar Product Development (Chapman & Hall/CRC Biostatistics Series)

Innovative Methods for Rare Disease Drug Development (Chapman & Hall/CRC Biostatistics Series)

Bioequivalence Studies in Drug Development: Methods and Applications: 47 (Statistics in Practice)

Multiple Testing Problems in Pharmaceutical Statistics (Chapman & Hall/CRC Biostatistics Series)

Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials (Springer Series in Pharmaceutical Statistics)

Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting: 67 (Chapman & Hall/CRC Biostatistics Series)

Statistics In the Pharmaceutical Industry: 14 (Chapman & Hall/CRC Biostatistics Series)

Multiple Testing Problems in Pharmaceutical Statistics: 33 (Chapman & Hall/CRC Biostatistics Series)

Biosimilar Clinical Development: Scientific Considerations and New Methodologies (Chapman & Hall/CRC Biostatistics Series)

Handbook of Bioequivalence Testing (Drugs and the Pharmaceutical Sciences)

Encyclopedia of Biopharmaceutical Statistics - Four Volume Set

Statistical Thinking for Non-Statisticians in Drug Regulation

Theory of Drug Development: 61 (Chapman & Hall/CRC Biostatistics Series)

Real-World Evidence in a Patient-Centric Digital Era (Chapman & Hall/CRC Biostatistics Series)

Theory of Drug Development (Chapman & Hall/CRC Biostatistics Series)

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (Statistics for Biology and Health)

Real-World Evidence in a Patient-Centric Digital Era (Chapman & Hall/CRC Biostatistics Series)

Multiregional Clinical Trials for Simultaneous Global New Drug Development (Chapman & Hall/CRC Biostatistics Series)

Medical Product Safety Evaluation: Biological Models and Statistical Methods (Chapman & Hall/CRC Biostatistics Series)

Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting (Chapman & Hall/CRC Biostatistics Series)

New Drug Development: An Introduction to Clinical Trials: Second Edition

Innovative Statistics in Regulatory Science (Chapman & Hall/CRC Biostatistics Series)

Quantitative Methods for Traditional Chinese Medicine Development: 83 (Chapman & Hall/CRC Biostatistics)

Pharmaceutical Statistics: MBSW 39, Muncie, Indiana, USA, May 16-18, 2016: 218 (Springer Proceedings in Mathematics & Statistics, 218)