skip to content
Analytical Similarity Assessment in Biosimilar Product Development. Preview this item
ClosePreview this item
Checking...

Analytical Similarity Assessment in Biosimilar Product Development.

Author: Shein-Chung Chow
Publisher: Milton : Chapman and Hall/CRC, 2018.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
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  Read more...
Rating:

(not yet rated) 0 with reviews - Be the first.

Subjects
More like this

Find a copy online

Links to this item

Find a copy in the library

&AllPage.SpinnerRetrieving; Finding libraries that hold this item...

Details

Genre/Form: Electronic books
Additional Physical Format: Print version:
Chow, Shein-Chung.
Analytical Similarity Assessment in Biosimilar Product Development.
Milton : Chapman and Hall/CRC, ©2018
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Shein-Chung Chow
ISBN: 9781351339469 135133946X
OCLC Number: 1051140391
Notes: 4.5 Evaluation of Reliability, Repeatability, and Reproducibility.
Description: 1 online resource (354 pages)
Contents: and Reproducibility Concluding remarks Critical Quality Attributes Introduction Identification of CQAs Classification of CQAs Concluding Remarks FDA Tiered Approach for Analytical Assessment Background Stepwise Approach Tier Equivalence Test Other tiered approaches Some Practical Considerations Concluding Remarks Sample Size Requirement Introduction Traditional Approach FDA's Current Thinking and Recommendation Sample Size Requirement Numerical Studies Concluding remarks Multiple References Background Method of Pairwise Comparisons Simultaneous Confidence Interval Reference Product Change Concluding remarks Extrapolation Across Indications Introduction An Example Development of. Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Author; Chapter 1: Introduction; 1.1 Background; 1.2 Past Experience for In Vitro Bioequivalence Testing; 1.2.1 Study Design and Data Collection; Emitted dose uniformity, priming, priming/re-priming, and tail-off profile; Spray pattern; Droplet size distribution; Plume geometry; 1.2.2 Bioequivalence Limit; 1.2.3 Statistical Methods; Non-comparative analysis; Non-profile Analysis; Profile Analysis; 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 Approach1.3.3 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; 1.4.7 Regulator's Current Thinking on Scientific Input; 1.4.8 A Proposed Unified Tiered Approach; 1.4.9 Practical Issues; How Similar is Similar?; Criteria for biosimilarity. Criteria for interchangeabilityBridging studies for assessing biosimilarity; 1.4.10 Remarks; 1.5 Aim and Scope of the Book; Chapter 2: Regulatory Approval Pathway of Biosimilar Products; 2.1 Introduction; 2.2 Regulatory Requirements; 2.2.1 World Health Organization (WHO); 2.2.2 European Union (EU); 2.2.3 North America (United States of America and Canada); 2.2.4 Asian Pacific Region (Japan, South Korea, and China); 2.2.5 Debatable Issues in Regulatory Requirements; 2.3 Analytical Studies for Structural/Functional Characteristics; 2.4 Global Harmonization; 2.5 Conclusion Remarks. Chapter 3: CMC Requirements for Biological Products3.1 Introduction; 3.2 CMC Development; 3.2.1 Fermentation and Purification Process; 3.2.2 Drug Substance and Product Characterization; 3.2.3 Reference Standards and Container Closure System; 3.2.4 Practical Issues; 3.3 Manufacturing Process Validation; 3.3.1 Manufacturing Process; 3.3.2 Process Validation; 3.3.3 Practical Issues; 3.4 Quality Control and Assurance; 3.4.1 General Principles; 3.4.2 Quality by Design; 3.5 Stability Analysis; 3.6 Concluding Remarks; Chapter 4: Analytical Method Validation; 4.1 Introduction. 4.2 Regulatory Requirements4.2.1 FDA Guidance on Analytical Procedures and Methods Validation; 4.2.2 ICH Guidance on Assay Validation; 4.2.3 United States Pharmacopeia and National Formulary (USP/NF); 4.3 Analytical Method Validation; 4.3.1 Validation Performance Characteristics; 4.3.2 Study Design; 4.3.3 Choice of Validation Performance Characteristics; 4.3.4 Acceptance Criteria; 4.4 Analysis of Validation Data; 4.4.1 Assessment of Accuracy, Linearity, and Specificity; 4.4.2 The Assessment of Assay Parameters Related to Variability.

Abstract:

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.

Reviews

User-contributed reviews
Retrieving GoodReads reviews...
Retrieving DOGObooks reviews...

Tags

Be the first.
Confirm this request

You may have already requested this item. Please select Ok if you would like to proceed with this request anyway.

Linked Data


Primary Entity

<http://www.worldcat.org/oclc/1051140391> # Analytical Similarity Assessment in Biosimilar Product Development.
    a schema:MediaObject, schema:CreativeWork, schema:Book ;
    library:oclcnum "1051140391" ;
    library:placeOfPublication <http://experiment.worldcat.org/entity/work/data/5404093653#Place/milton> ; # Milton
    schema:about <http://experiment.worldcat.org/entity/work/data/5404093653#Topic/medical_biostatistics> ; # MEDICAL / Biostatistics
    schema:about <http://experiment.worldcat.org/entity/work/data/5404093653#Topic/drug_development> ; # Drug development
    schema:about <http://experiment.worldcat.org/entity/work/data/5404093653#Topic/medical_pharmacology> ; # MEDICAL / Pharmacology
    schema:about <http://experiment.worldcat.org/entity/work/data/5404093653#Topic/drug_approval> ; # Drug approval
    schema:about <http://dewey.info/class/615.1/e23/> ;
    schema:bookFormat schema:EBook ;
    schema:creator <http://experiment.worldcat.org/entity/work/data/5404093653#Person/chow_shein_chung> ; # Shein-Chung Chow
    schema:datePublished "2018" ;
    schema:description "Cover; Half Title; Title Page; Copyright Page; Table of Contents; Preface; Author; Chapter 1: Introduction; 1.1 Background; 1.2 Past Experience for In Vitro Bioequivalence Testing; 1.2.1 Study Design and Data Collection; Emitted dose uniformity, priming, priming/re-priming, and tail-off profile; Spray pattern; Droplet size distribution; Plume geometry; 1.2.2 Bioequivalence Limit; 1.2.3 Statistical Methods; Non-comparative analysis; Non-profile Analysis; Profile Analysis; 1.2.4 Sample Size Requirement; 1.3 Analytical Similarity Assessment; 1.3.1 Tier 1 Equivalence Test."@en ;
    schema:description "and Reproducibility Concluding remarks Critical Quality Attributes Introduction Identification of CQAs Classification of CQAs Concluding Remarks FDA Tiered Approach for Analytical Assessment Background Stepwise Approach Tier Equivalence Test Other tiered approaches Some Practical Considerations Concluding Remarks Sample Size Requirement Introduction Traditional Approach FDA's Current Thinking and Recommendation Sample Size Requirement Numerical Studies Concluding remarks Multiple References Background Method of Pairwise Comparisons Simultaneous Confidence Interval Reference Product Change Concluding remarks Extrapolation Across Indications Introduction An Example Development of."@en ;
    schema: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."@en ;
    schema:exampleOfWork <http://worldcat.org/entity/work/id/5404093653> ;
    schema:genre "Electronic books"@en ;
    schema:inLanguage "en" ;
    schema:isSimilarTo <http://worldcat.org/entity/work/data/5404093653#CreativeWork/analytical_similarity_assessment_in_biosimilar_product_development> ;
    schema:name "Analytical Similarity Assessment in Biosimilar Product Development."@en ;
    schema:productID "1051140391" ;
    schema:publication <http://www.worldcat.org/title/-/oclc/1051140391#PublicationEvent/milton_chapman_and_hall_crc_2018> ;
    schema:publisher <http://experiment.worldcat.org/entity/work/data/5404093653#Agent/chapman_and_hall_crc> ; # Chapman and Hall/CRC
    schema:url <http://public.ebookcentral.proquest.com/choice/publicfullrecord.aspx?p=5493384> ;
    schema:url <https://nls.ldls.org.uk/welcome.html?ark:/81055/vdc_100066351893.0x000001> ;
    schema:url <https://www.taylorfrancis.com/books/9781351339469> ;
    schema:url <https://shibboleth2sp.gar.semcs.net/Shibboleth.sso/Login?entityID=https%3A%2F%2Fnetlogin.strath.ac.uk%2Fshibboleth&target=https%3A%2F%2Fshibboleth2sp.gar.semcs.net%2Fshib%3Fdest%3Dhttp%253A%252F%252Fwww.vlebooks.com%252FSHIBBOLETH%253Fdest%253Dhttp%25253A%25252F%25252Fwww.vlebooks.com%25252Fvleweb%25252Fproduct%25252Fopenreader%25253Fid%25253DStrathclyd%252526isbn%25253D9781351339469> ;
    schema:url <http://www.vlebooks.com/vleweb/product/openreader?id=none&isbn=9781351339469> ;
    schema:workExample <http://worldcat.org/isbn/9781351339469> ;
    wdrs:describedby <http://www.worldcat.org/title/-/oclc/1051140391> ;
    .


Related Entities

<http://experiment.worldcat.org/entity/work/data/5404093653#Agent/chapman_and_hall_crc> # Chapman and Hall/CRC
    a bgn:Agent ;
    schema:name "Chapman and Hall/CRC" ;
    .

<http://experiment.worldcat.org/entity/work/data/5404093653#Person/chow_shein_chung> # Shein-Chung Chow
    a schema:Person ;
    schema:familyName "Chow" ;
    schema:givenName "Shein-Chung" ;
    schema:name "Shein-Chung Chow" ;
    .

<http://experiment.worldcat.org/entity/work/data/5404093653#Topic/medical_biostatistics> # MEDICAL / Biostatistics
    a schema:Intangible ;
    schema:name "MEDICAL / Biostatistics"@en ;
    .

<http://experiment.worldcat.org/entity/work/data/5404093653#Topic/medical_pharmacology> # MEDICAL / Pharmacology
    a schema:Intangible ;
    schema:name "MEDICAL / Pharmacology"@en ;
    .

<http://worldcat.org/entity/work/data/5404093653#CreativeWork/analytical_similarity_assessment_in_biosimilar_product_development>
    a schema:CreativeWork ;
    rdfs:label "Analytical Similarity Assessment in Biosimilar Product Development." ;
    schema:description "Print version:" ;
    schema:isSimilarTo <http://www.worldcat.org/oclc/1051140391> ; # Analytical Similarity Assessment in Biosimilar Product Development.
    .

<http://worldcat.org/isbn/9781351339469>
    a schema:ProductModel ;
    schema:isbn "135133946X" ;
    schema:isbn "9781351339469" ;
    .

<https://www.taylorfrancis.com/books/9781351339469>
    rdfs:comment "Click here to view." ;
    .


Content-negotiable representations

Close Window

Please sign in to WorldCat 

Don't have an account? You can easily create a free account.