000			04673nam a2200457Ii 4500
001			9780203705131
003			FlBoTFG
005			20220509192912.0
006			m o d
007			cr
008			181112s2018 fluab ob 001 0 eng d
020			_a9780203705131 _q(e-book : PDF)
035			_a(OCoLC)1049800753
040			_aFlBoTFG _cFlBoTFG _erda
041	1		_aeng
050		4	_aRM301.25
072		7	_aMAT _x029000 _2bisacsh
072		7	_aMED _x071000 _2bisacsh
072		7	_aMED _x090000 _2bisacsh
072		7	_aMBNS _2bicscc
082	0	4	_a 615.1/9
100	1		_aChow, Shein-Chung, _eauthor.
245	1	0	_aAnalytical Similarity Assessment in Biosimilar Product Development / _cby Shein-Chung Chow.
250			_aFirst edition.
264		1	_aBoca Raton, FL : _bChapman and Hall/CRC, _c2018.
300			_a1 online resource (354 pages) : _b70 illustrations, text file, PDF
336			_atext _2rdacontent
337			_acomputer _2rdamedia
338			_aonline resource _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0	0	_tIntroduction -- _tBackground -- _tPast Experience for In Vitro Bioequivalence Testing -- _tAnalytical Similarity Assessment -- _tScientific Factors and practical issues -- _tAim and Scope of the Book -- _tRegulatory Approval Pathway of Biosimilar Products -- _tIntroduction -- _tRegulatory requirements -- _tAnalytical Studies for Functional/Structural Characterization -- _tGlobal harmonization -- _tConcluding remarks -- _tCMC Requirements -- _tIntroduction -- _tCMC Development -- _tManufacturing Process Validation -- _tQuality Control and Assurance -- _tStability Analysis -- _tConcluding Remarks -- _tAssay Development and Process Validation -- _tIntroduction -- _tRegulatory Requirements -- _tAnalytical Method Validation -- _tAnalysis of Validation Data -- _tEvaluation of Reliability, Repeatability, and Reproducibility -- _tConcluding remarks -- _tCritical Quality Attributes -- _tIntroduction -- _tIdentification of CQAs -- _tClassification of CQAs -- _tConcluding Remarks -- _tFDA Tiered Approach for Analytical Assessment -- _tBackground -- _tStepwise Approach -- _tTier Equivalence Test -- _tOther tiered approaches -- _tSome Practical Considerations -- _tConcluding Remarks -- _tSample Size Requirement -- _tIntroduction -- _tTraditional Approach -- _tFDAs Current Thinking and Recommendation -- _tSample Size Requirement -- _tNumerical Studies -- _tConcluding remarks -- _tMultiple References -- _tBackground -- _tMethod of Pairwise Comparisons -- _tSimultaneous Confidence Interval -- _tReference Product Change -- _tConcluding remarks -- _tExtrapolation Across Indications -- _tIntroduction -- _tAn Example -- _tDevelopment of Sensitivity Index -- _tAssessment of Sensitivity Index -- _tStatistical Inference of Extrapolation -- _tConcluding Remarks -- _tCase Studies - FDA Submissions -- _tFDA Abbreviated Licensure Pathway -- _tSponsors Strategy for Regulatory Submission -- _tAvastin Biosimilar Regulatory Submission -- _tHerceptin Biosimilar Regulatory Submission -- _tConcluding Remarks -- _t--Practical and Challenging Issues -- _tIntroduction -- _tHypotheses versus Confidence Interval Approach -- _tTotality-of-the-evidence -- _tInconsistencies Between Tired Approaches -- _tIndividual bioequivalence -- _tCommonly Asked Questions from the Sponsors -- _tConcluding Remarks -- _tRecent Development-- -- _t Introduction -- _t Comparing Means versus Comparing Variances -- _t Switching Design -- _t Non-Medical Switching -- _t FDA guidance on Analytical Similarity Assessment -- _t Concluding Remarks.
520	3		_aThis 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.
530			_aAlso available in print format.
650		0	_aDrug development.
650		0	_aDrug approval.
650		7	_aMEDICAL / Pharmacology. _2bisacsh
650		7	_aMEDICAL / Biostatistics. _2bisacsh
655		0	_aElectronic books.
710	2		_aTaylor and Francis.
776	0	8	_iPrint version: _z9781138307339
856	4	0	_uhttps://www.taylorfrancis.com/books/9780203705131 _zClick here to view.
999			_c126160 _d126160