Cantitate/Preț
Produs
Total produse
Vezi coșul
Analytical Similarity Assessment in Biosimilar Product Development de Shein-Chung Chow

Analytical Similarity Assessment in Biosimilar Product Development

Autor Shein-Chung Chow
en Limba Engleză Paperback – 18 dec 2020
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.




Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (1) 32346 lei  6-8 săpt.
  CRC Press – 18 dec 2020 32346 lei  6-8 săpt.
Hardback (1) 102255 lei  6-8 săpt.
  CRC Press – aug 2018 102255 lei  6-8 săpt.

Preț: 32346 lei

Preț vechi: 38886 lei
-17% Nou

Puncte Express: 485
Preț estimativ în valută:
6190€ • 6512$ • 5165£

Carte tipărită la comandă

Livrare economică 09-23 ianuarie 25

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9780367733834
ISBN-10: 0367733838
Pagini: 354
Dimensiuni: 156 x 234 mm
Greutate: 0.65 kg
Ediția:1
Editura: CRC Press
Colecția Chapman and Hall/CRC

Cuprins

1.1 Background 1.2 Past Experience for In Vitro Bioequivalence Testing 1.2.1 Study Design and Data Collection 1.2.2 Bioequivalence Limit 1.2.3 Statistical Methods 1.2.4 Sample Size Requirement 1.3 Analytical Similarity Assessment 1.3.1 Tier 1 Equivalence Test 1.3.2 Tier 2 Quality Range Approach 1.3.3 Tier 3 Raw Data and Graphical Comparison 1.4 Scientific Factors and Practical Issues 1.4.1 Fundamental Similarity Assumption 1.4.2 Primary Assumptions for Tiered Approach 1.4.3 Fixed Approach for Margin Selection 1.4.4 Inconsistent Test Results between Tiered Approaches 1.4.5 Sample Size Requirement 1.4.6 Relationship between Similarity Limit and Variability

Notă biografică



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.

Descriere

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 will cover current issues, and recent development in analytical similarity assessment.