MARC Record from marc_columbia

LEADER: 22984cam a2200697 i 4500
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005 20220521232445.0
006 m o d
007 cr |||||||||||
008 180222s2018 flu ob 001 0 eng
010 $a 2020691425
035 $a(OCoLC)on1037280178
035 $a(NNC)15132922
040 $aDLC$beng$erda$cDLC$dN$T$dEBLCP$dYDX$dOCLCF$dSTF$dCOO$dEZ9$dUBY$dU3W$dINT$dMERER$dWYU$dTYFRS$dS2H$dUKAHL$dZCU$dCRCPR$dCHVBK$dOCLCO$dUKMGB$dOCLCO
015 $aGBC228708$2bnb
016 7 $a018877638$2Uk
019 $a1011115080$a1048767987$a1099949885$a1289815260
020 $a9781351646345$qebook
020 $a1351646346
020 $z9781498721400$qhardback : acid-free paper
020 $a9781498721417$q(electronic bk.)
020 $a1498721419$q(electronic bk.)
020 $a9781315120034$q(electronic bk.)
020 $a1315120038$q(electronic bk.)
020 $a9781351636803
020 $a1351636804
020 $z1498721400
024 8 $a10.1201/9781315120034$2doi
035 $a(OCoLC)1037280178$z(OCoLC)1011115080$z(OCoLC)1048767987$z(OCoLC)1099949885$z(OCoLC)1289815260
037 $a9781351646345$bIngram Content Group
050 00 $aTP248.25.A96
072 7 $aSCI$x013060$2bisacsh
072 7 $aTEC$x009010$2bisacsh
082 00 $a660.60285$223
049 $aZCUA
245 00 $aStatistics for Biotechnology Process Development /$cEdited by Todd Coffey, Harry Yang.
264 1 $aBoca Raton :$bCRC Press, Taylor and Francis Group, CRC Press is an imprint of the Taylor and Francis Group, an informa business,$c[2018]
300 $a1 online resource
336 $atext$btxt$2rdacontent
337 $acomputer$bc$2rdamedia
338 $aonline resource$bcr$2rdacarrier
500 $a"A Chapman & Hall book."
504 $aIncludes bibliographical references and index.
588 $aDescription based on print version record.
505 00 $gMachine generated contents note:$g1.1.$tBackground /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.2.$tBiopharmaceutical Development /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.3.$tStatistics in Bioprocess Development /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.$tStatistical Inferences /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.1.$tExample /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.2.$tRandom Variables /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.3.$tContinuous Distributions /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.3.1.$tGaussian Distribution /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.3.2.$tStudent's t-Distribution /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.3.3.$tChi-Square Distribution /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.3.4.$tF-Distribution /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.4.$tDiscrete Distributions /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.4.1.$tBinomial /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.4.4.2.$tPoisson /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.5.$tSampling Considerations /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.5.1.$tNon-Random Sample /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.5.2.$tSimple Random Sampling /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.5.3.$tStratified Sampling /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.5.4.$tSystematic Sampling /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.6.$tStatistical Estimation /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.6.1.$tPoint Estimate /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.6.2.$tInterval Estimation /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.6.2.1.$tConfidence Interval /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.6.2.2.$tPrediction Interval /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.6.2.3.$tTolerance Interval /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.$tHypothesis Testing /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.1.$tType I and Type II Errors /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.2.$tSignificance Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.3.$tStatistical Significance /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.4.$tEquivalence Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.4.1.$tIssues with Significance Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.7.4.2.$tAlternate Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.8.$tSample Size /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.8.1.$tSample Size for Estimation /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.8.2.$tSample Size for Significance Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.8.3.$tSample Size for Equivalence Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.9.$tSelection of Method for Data Analysis /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.9.1.$tExample /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.9.2.$tTest Model Assumptions /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.9.2.1.$tQ-Q Plot /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.9.2.2.$tNonparametric Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.9.3.$tData Transformation /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.$tRemoval of Outliers /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.1.$tDefinition /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.2.$tOutlier Tests /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.2.1.$tGrubbs' Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.2.2.$tDixon's Test /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.2.3.$tOther Outlier Tests /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.10.2.4.$tModel-Based Method /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.11.$tBayesian Inference /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g1.12.$tConcluding Remarks /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$tReferences /$rHarry Yang /$rSteven J. Novick /$rLorin Roskos --$g2.1.$tIntroduction and Overview /$rTodd Coffey --$g2.1.1.$tDefinitions /$rTodd Coffey --$g2.1.2.$tGeneral Classes of Designs /$rTodd Coffey --$g2.2.$tBefore You Start: Planning for Success /$rTodd Coffey --$g2.2.1.$tDefining the Experimental Purpose /$rTodd Coffey --$g2.2.2.$tSelecting the Responses /$rTodd Coffey --$g2.2.3.$tIdentifying Factors, Levels, and Ranges /$rTodd Coffey --$g2.2.4.$tFundamental Design Principles /$rTodd Coffey --$g2.3.$tDesign Building Blocks /$rTodd Coffey --$g2.3.1.$tDesign Notation /$rTodd Coffey --$g2.3.2.$tFactorial Designs /$rTodd Coffey --$g2.3.3.$t2k-p Fractional Factorial Designs /$rTodd Coffey --$g2.4.$tChoosing a Design /$rTodd Coffey --$g2.4.1.$tScreening Experiments /$rTodd Coffey --$g2.4.2.$tCharacterization Experiments /$rTodd Coffey --$g2.4.3.$tOptimization Experiments /$rTodd Coffey --$g2.4.4.$tAdvantages and Disadvantages of the Classical Approach /$rTodd Coffey --$g2.5.$tAnalyzing a Single Response /$rTodd Coffey --$g2.5.1.$tLinear Regression Fundamentals /$rTodd Coffey --$g2.5.2.$tLinear Regression Model /$rTodd Coffey --$g2.5.3.$tModel Fitting /$rTodd Coffey --$g2.5.4.$tModel Assumptions /$rTodd Coffey --$g2.5.5.$tStatistical Analysis for Screening Experiments /$rTodd Coffey --$g2.5.6.$tStatistical Analysis for Characterization Experiments /$rTodd Coffey --$g2.5.7.$tStatistical Analysis for Optimization Experiments /$rTodd Coffey --$g2.6.$tAnalyzing Multiple Responses Simultaneously /$rTodd Coffey --$g2.7.$tSummary /$rTodd Coffey --$tReferences /$rTodd Coffey --$g3.1.$tIntroduction /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.$tDesign Space Definition and Visualization /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.1.$tQuality Target Product Profile and Critical Quality Attributes /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.2.$tCritical Process Parameters /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.3.$tDesign of Experiments /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.4.$tModel /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.5.$tProbability of Success /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.6.$tVisualization of the Results /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.7.$tDetermining and Reporting the Design Space /$rPerceval Sondag /$rPierre Lebrun /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.8.$tDesign Space vs. PAR /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.2.9.$tIllustration /$rPerceval Sondag /$rPierre Lebrun /$rXavier Lories /$rBruno Boulanger /$rEric Rozet /$rJean-Francois Michiels --$g3.3.$tExample /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories /$rJean-Francois Michiels /$rEric Rozet /$rBruno Boulanger --$g3.4.$tConclusion /$rPierre Lebrun /$rPerceval Sondag /$rEric Rozet /$rJean-Francois Michiels /$rXavier Lories /$rBruno Boulanger --$tReferences /$rBruno Boulanger /$rJean-Francois Michiels /$rEric Rozet /$rPierre Lebrun /$rPerceval Sondag /$rXavier Lories --$g4.1.$tIntroduction /$rRichard K.
505 00 $tBurdick --$g4.1.1.$tDescription of an Analytical Procedure /$rRichard K. Burdick --$g4.1.2.$tDescription of Life Cycle Approach /$rRichard K. Burdick --$g4.1.3.$tMeasurement Error Models /$rRichard K. Burdick --$g4.2.$tStage 1: Procedure Design /$rRichard K. Burdick --$g4.3.$tStage 2: Procedure Performance Qualification /$rRichard K. Burdick --$g4.3.1.$tIndividual Qualification for Accuracy and Precision /$rRichard K. Burdick --$g4.3.2.$tIncorporation of a Ruggedness Factor /$rRichard K. Burdick --$g4.3.3.$tPower Considerations /$rRichard K. Burdick --$g4.3.4.$tHolistic Qualification of a Bioassay Method /$rRichard K. Burdick --$g4.3.5.$tHolistic Qualification of a Relative Purity Method /$rRichard K. Burdick --$g4.3.6.$tLimit of Detection (LOD) and Linearity /$rRichard K. Burdick --$g4.4.$tStep 3: Continued Procedure Performance Verification /$rRichard K. Burdick --$tReferences /$rRichard K. Burdick --$g5.1.$tIntroduction /$rDavid Lansky --$g5.1.1.$tSupporting a Biotechnology Product /$rDavid Lansky --$g5.1.2.$tProduct Specifications Ensure Efficacy and Safety /$rDavid Lansky --$g5.2.$tStatistical and Strategic Introduction /$rDavid Lansky --$g5.2.1.$tCommon Properties of Bioassays /$rDavid Lansky --$g5.2.2.$tIssues with Common Analysis Strategies /$rDavid Lansky --$g5.3.$tRecommended Bioassay Analysis Strategy /$rDavid Lansky --$g5.3.1.$tTransformation /$rDavid Lansky --$g5.3.2.$tOutlier Management /$rDavid Lansky --$g5.3.3.$tAssay Acceptance Criteria /$rDavid Lansky --$g5.3.4.$tMixed Models /$rDavid Lansky --$g5.3.5.$tEquivalence Testing for Similarity /$rDavid Lansky --$g5.3.6.$tModel Selection /$rDavid Lansky --$g5.3.7.$tBioassay Analysis Summary /$rDavid Lansky --$g5.4.$tStrategic Design /$rDavid Lansky --$g5.4.1.$tDesign Goals /$rDavid Lansky --$g5.4.2.$tPractical and Strategic Design Constraints /$rDavid Lansky --$g5.4.3.$tOther Bioassay Design Considerations /$rDavid Lansky.
505 00 $gNote continued:$g5.4.4.$tDesign Strategies during Bioassay Development /$rDavid Lansky --$g5.5.$tOther Ways to Be Strategic by Combining Design, Analysis, and Use of Bioassays /$rDavid Lansky --$g5.6.$tQualification/Validation Experiment Design and Analysis /$rDavid Lansky --$g5.6.1.$tDiscussion of the Qualification Experiment Results /$rDavid Lansky --$g5.7.$tSummary /$rDavid Lansky --$tReferences /$rDavid Lansky --$g6.1.$tRegulatory Requirements /$rHarry Yang --$g6.2.$tIdentification of Critical Quality Attributes /$rHarry Yang --$g6.3.$tSelection of Critical Process Parameters and Input Material Attributes /$rHarry Yang --$g6.4.$tControl Strategies /$rHarry Yang --$g6.4.1.$tInput Material Control /$rHarry Yang --$g6.4.2.$tIn-Process Control /$rHarry Yang --$g6.4.2.1.$tProcedural Controls /$rHarry Yang --$g6.4.2.2.$tProcess Parameter Controls /$rHarry Yang --$g6.4.2.3.$tIn-Process Testing /$rHarry Yang --$g6.4.3.$tRelease Testing /$rHarry Yang --$g6.4.4.$tStability Trending /$rHarry Yang --$g6.4.5.$tComparability Testing /$rHarry Yang --$g6.4.6.$tContinuous Process Verification /$rHarry Yang --$g6.5.$tConsiderations in Setting Acceptance Criteria /$rHarry Yang --$g6.5.1.$tFrame of Reference /$rHarry Yang --$g6.5.2.$tSources of Variation /$rHarry Yang --$g6.5.3.$tImpact of Correlation /$rHarry Yang --$g6.5.4.$tClinical Relevance Limits /$rHarry Yang --$g6.5.5.$tShelf Life /$rHarry Yang --$g6.5.6.$tRelease Limit /$rHarry Yang --$g6.5.6.1.$tFixed Effect Model /$rHarry Yang --$g6.6.$tMultivariate Specifications /$rHarry Yang --$g6.7.$tConcluding Remarks /$rHarry Yang --$tReferences /$rHarry Yang --$g7.1.$tIntroduction /$rLaura D. Pack --$g7.2.$tWord about Study Design /$rLaura D. Pack --$g7.3.$tWord about Source Data /$rLaura D. Pack --$g7.4.$tStability Models for Use in This Chapter /$rLaura D. Pack --$g7.4.1.$tFixed Lot Model /$rLaura D. Pack --$g7.4.1.1.$tStatistical Assumptions for the Fixed Lot Model /$rLaura D. Pack --$g7.4.1.2.$tFitting the Fixed Lot Model in JMP® /$rLaura D. Pack --$g7.4.1.3.$tObtaining Output from the Fixed Lot Model Fit in JMP® /$rLaura D. Pack --$g7.4.1.4.$tVerifying Statistical Assumptions for the Fixed Lot Model in MP® /$rLaura D. Pack --$g7.4.2.$tRandom Lot Model /$rLaura D. Pack --$g7.4.2.1.$tStatistical Assumptions for the Random Lot Model /$rLaura D. Pack --$g7.4.2.2.$tFitting the Random Lot Model in JMP® /$rLaura D. Pack --$g7.4.2.3.$tObtaining Output from the Random Lot Model Fit in JMP® /$rLaura D. Pack --$g7.4.2.4.$tVerifying Statistical Assumptions for the Random Lot Model in JMP® /$rLaura D. Pack --$g7.4.3.$tQualitative Predictor Model /$rLaura D. Pack --$g7.4.3.1.$tStatistical Assumptions for the Qualitative Predictor Model /$rLaura D. Pack --$g7.4.3.2.$tFitting the Qualitative Predictor Model in JMP® /$rLaura D. Pack --$g7.4.3.3.$tObtaining Output from the Qualitative Predictor Model Fit in JMP® /$rLaura D. Pack --$g7.4.3.4.$tVerifying Statistical Assumptions in JMP® /$rLaura D. Pack --$g7.5.$tOutline /$rLaura D. Pack --$g7.6.$tIs There a Trend on Stability? /$rLaura D. Pack --$g7.6.1.$tCan a Particular CQA Be Considered "Stability Indicating"? /$rLaura D. Pack --$g7.6.2.$tIs the Change over Time Statistically Significant? /$rLaura D. Pack --$g7.6.3.$tIs the Change over Time Practically Significant? /$rLaura D. Pack --$g7.6.4.$tIs an Individual Result in Trend? /$rLaura D. Pack --$g7.6.5.$tIs a Stability Lot in Trend? /$rLaura D. Pack --$g7.6.6.$tHow Can I Establish a Stability Trending Program? /$rLaura D. Pack --$g7.6.7.$tHow Can I Perform an Annual "Trend Analysis" as Required for Commercially Approved Products? /$rLaura D. Pack --$g7.7.$tHow Is the Stability Profile Related to the Expiry Period? /$rLaura D. Pack --$g7.7.1.$tWhat Is the Appropriate Expiry or Retest Period for My Product? /$rLaura D. Pack --$g7.7.2.$tWill an Individual Lot Meet Its Intended Expiry Period? /$rLaura D. Pack --$g7.7.3.$tCan I Extend the Expiry Period? /$rLaura D. Pack --$g7.7.4.$tHow Can I Model Behavior for End-to-End Stability for Multiple Product Stages? /$rLaura D. Pack --$g7.8.$tHow Does the Stability Profile Relate to the Specification Limit? /$rLaura D. Pack --$g7.8.1.$tWhat Is the Appropriate Specification Limit to Achieve a Desired Expiry or Retest Period? /$rLaura D. Pack --$g7.8.2.$tIs It Appropriate to Have a Tighter Specification Limit at Lot Release? /$rLaura D. Pack --$g7.8.3.$tDoes Changing the Specification Limit Impact the Expiry? /$rLaura D. Pack --$g7.8.4.$tWhat Is the Probability of an Individual 00S Result on Stability? /$rLaura D. Pack --$g7.9.$tHow Much Exposure to a Particular Condition Can Be Allowed without Impacting the Shelf Life? /$rLaura D. Pack --$g7.9.1.$tWhat Is an Appropriate Limit for Exposure to Temperatures above Recommended Storage? /$rLaura D. Pack --$g7.9.2.$tHow Much Light Exposure Is Acceptable? /$rLaura D. Pack --$g7.9.3.$tDoes Temperature Cycling Impact My Product? /$rLaura D. Pack --$g7.10.$tDo Two (Or More) Different Permutations of My Molecule Change the Same Way over Time? /$rLaura D. Pack --$g7.10.1.$tCan I Apply a Bracketing Approach to Several Different Configurations of the Same Product Formulation? /$rLaura D. Pack --$g7.10.2.$tIs One Formulation, Container, or Configuration More Stable at a Given Temperature? /$rLaura D. Pack --$g7.10.3.$tIs the Stability Profile the Same after a Manufacturing or Process Change? /$rLaura D. Pack --$g7.11.$tConclusion /$rLaura D. Pack --$tReferences /$rLaura D.
505 00 $rPack --$g8.1.$tIntroduction /$rTara Scherder /$rKatherine Giacoletti --$g8.2.$tStatistical Tools for CPV /$rTara Scherder /$rKatherine Giacoletti --$g8.2.1.$tSPC Phases, Control Charts and Process Monitoring /$rTara Scherder /$rKatherine Giacoletti --$g8.2.2.$tShewhart Control Chart for Individual Measurements /$rTara Scherder /$rKatherine Giacoletti --$g8.2.3.$tProcess Capability /$rTara Scherder /$rKatherine Giacoletti --$g8.3.$tSpecial Considerations for CPV in the Biopharmaceutical Industry /$rTara Scherder /$rKatherine Giacoletti --$g8.3.1.$tRandomness, Independence, and Normality-Lack Thereof /$rTara Scherder /$rKatherine Giacoletti --$g8.4.$tBusiness Considerations for Implementation of CPV /$rTara Scherder /$rKatherine Giacoletti --$g8.5.$tOther Control Charts /$rTara Scherder /$rKatherine Giacoletti --$tReferences /$rTara Scherder /$rKatherine Giacoletti --$g9.1.$tBackground /$rJianchun Zhang /$rHarry Yang --$g9.2.$tMultivariate Analysis /$rJianchun Zhang /$rHarry Yang --$g9.2.1.$tMultiple Regression /$rJianchun Zhang /$rHarry Yang --$g9.2.1.1.$tOverlapping Response Surfaces /$rJianchun Zhang /$rHarry Yang --$g9.2.1.2.$tDesirability Approach /$rJianchun Zhang /$rHarry Yang --$g9.2.1.3.$tBayesian Approach /$rJianchun Zhang /$rHarry Yang --$g9.2.2.$tPCA /$rJianchun Zhang /$rHarry Yang --$g9.2.3.$tPLS /$rJianchun Zhang /$rHarry Yang --$g9.3.$tMultivariate Process Control /$rJianchun Zhang /$rHarry Yang --$g9.3.1.$tProcess Control /$rJianchun Zhang /$rHarry Yang --$g9.3.2.$tBatch Process Monitoring /$rJianchun Zhang /$rHarry Yang --$g9.4.$tApplications /$rJianchun Zhang /$rHarry Yang --$g9.4.1.$tOperating Ranges of Chromatography Assay /$rJianchun Zhang /$rHarry Yang --$g9.4.2.$tOptimization of Cell Culture System /$rJianchun Zhang /$rHarry Yang --$g9.4.3.$tQuantification of Scale-Down Model for Bioreactor /$rJianchun Zhang /$rHarry Yang --$g9.4.4.$tPCA-Based Process Control /$rJianchun Zhang /$rHarry Yang --$g9.5.$tConcluding Remarks /$rJianchun Zhang /$rHarry Yang --$tReferences /$rJianchun Zhang /$rHarry Yang --$g10.1.$tIntroduction /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.2.$tCommon Steps of a Robustness Assessment /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.3.$tDesign of Experiments /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.4.$tEvaluation of Assay Robustness /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.4.1.$tGraphical Evaluation by Half-Normal Plot /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.4.2.$tDong's Method /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.4.3.$tLinear Model /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.4.4.$tStatistical vs. Practical Significance /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.5.$tCase Study /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g10.6.$tDiscussions /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$tReferences /$rBinbing Yu /$rLingmin Zeng /$rHarry Yang --$g11.1.$tRegulatory Guidance /$rHarry Yang --$g11.2.$tRisk-Based Sampling Plans /$rHarry Yang --$g11.3.$tApplications /$rHarry Yang --$g11.3.1.$tRaw Material, Drug Substance, and Finished Product Release /$rHarry Yang --$g11.3.2.$tProcess Efficiency /$rHarry Yang --$g11.3.3.$tEnvironmental Monitoring /$rHarry Yang --$g11.3.4.$tStability Testing /$rHarry Yang --$g11.4.$tAcceptance Sampling for Lot Inspection /$rHarry Yang --$g11.4.1.$tAcceptance Sampling Plan /$rHarry Yang --$g11.4.2.$tQuality Level /$rHarry Yang --$g11.4.3.$tOperating Characteristic Curve /$rHarry Yang --$g11.4.4.$tSingle Attribute Sampling /$rHarry Yang --$g11.4.5.$tVariables Sampling /$rHarry Yang --$g11.4.6.$tSelection of Sampling Plan /$rHarry Yang --$g11.4.7.$tDouble Sampling Plan /$rHarry Yang --$g11.5.$tAcceptance Sampling of Liquid Product /$rHarry Yang --$g11.5.1.$tPrefiltration Bioburden Control /$rHarry Yang --$g11.5.2.$tPerformance of Prefiltration Test Procedures /$rHarry Yang --$g11.5.3.$tRisk Mitigation through Sterile Filtration /$rHarry Yang --$g11.6.$tSampling for Stability Testing /$rHarry Yang --$g11.7.$tSampling and Environmental Monitoring /$rHarry Yang --$g11.7.1.$tSampling Site, Timing, and Frequency /$rHarry Yang --$g11.7.2.$tAlert and Action Limits /$rHarry Yang --$g11.8.$tConcluding Remarks /$rHarry Yang --$tReferences /$rHarry Yang.
520 2 $a"The use of statistics in process development is increasing throughout the biotechnology industry, due in part to an FDA mandate demanding the increased use of statistical concepts, the recognition of the importance of statistics, and the availability of powerful and user-friendly software. This book gives an overview of statistical methods for biotechnology process development, with an emphasis on application and minimal theoretical details. Examples using real data and case studies with JMP software are used throughout to illustrate topics."--Provided by publisher.
650 0 $aBiotechnology$xData processing.
650 6 $aBiotechnologie$xInformatique.
650 7 $aSCIENCE$xChemistry$xIndustrial & Technical.$2bisacsh
650 7 $aTECHNOLOGY & ENGINEERING$xChemical & Biochemical.$2bisacsh
650 7 $aBiotechnology$xData processing.$2fast$0(OCoLC)fst00832735
655 0 $aElectronic books.
655 4 $aElectronic books.
700 1 $aCoffey, Todd,$eeditor.
700 1 $aYang, Harry,$eeditor.
776 08 $iPrint version:$tStatistics for Biotechnology Process Development$dBoca Raton : CRC Press, Taylor & Francis Group, CRC Press is an imprint of the Taylor & Francis Group, an informa business, [2018]$z9781498721400 (hardback : acid-free paper)$w(DLC) 2018002841
856 40 $uhttp://www.columbia.edu/cgi-bin/cul/resolve?clio15132922$zTaylor & Francis eBooks
852 8 $blweb$hEBOOKS