{"product_id":"compatibility-of-pharmaceutical-solutions-and-contact-materials-9780470281765","title":"Compatibility of Pharmaceutical Solutions and","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis book specifically addresses the safety aspects of compatibility for drugs and their delivery devices and containers. The author deals with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\"The book provides a very detailed review of approaches for generating and further investigating extractables and leachables results, with advice on the levels of investigation appropriate to each stage of product development.\" (\u003ci\u003eBTS Newsletter\u003c\/i\u003e, Summer 2010)\u003cbr\u003e \u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface and Acknowledgments xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart A General Concepts 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1. Introduction 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral Discussion 3\u003c\/p\u003e \u003cp\u003eKey Definitions 6\u003c\/p\u003e \u003cp\u003eThe Interacting Parties 6\u003c\/p\u003e \u003cp\u003eExtractables versus Leachables 7\u003c\/p\u003e \u003cp\u003eRegulatory Perspectives for Performing Compatibility and\/or Safety Assessments 13\u003c\/p\u003e \u003cp\u003eThe U.S. Food and Drug Administration Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics 14\u003c\/p\u003e \u003cp\u003eEuropean Medicines Agency (EMEA) Guideline on Plastic Immediate Packaging Materials 15\u003c\/p\u003e \u003cp\u003eFDA Guidance for Industry Inhalation Products 18\u003c\/p\u003e \u003cp\u003eMedical Devices 20\u003c\/p\u003e \u003cp\u003eAn Overview of Strategies for Performing Safety Assessments 21\u003c\/p\u003e \u003cp\u003eThe Generalized Strategy for Safety Assessments 22\u003c\/p\u003e \u003cp\u003eMoving Forward 24\u003c\/p\u003e \u003cp\u003eReferences 25\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2. Nomenclature and General Concepts 27\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral 27\u003c\/p\u003e \u003cp\u003eNomenclature 27\u003c\/p\u003e \u003cp\u003ePrimary Definitions 28\u003c\/p\u003e \u003cp\u003eConstituents of a Material or Construct 29\u003c\/p\u003e \u003cp\u003eClassification of Extracting Media 31\u003c\/p\u003e \u003cp\u003eClassification of Extraction Strategies 32\u003c\/p\u003e \u003cp\u003eExample Extraction Conditions Applied to a Model System 39\u003c\/p\u003e \u003cp\u003eCorrelation 43\u003c\/p\u003e \u003cp\u003eFactors That Influence the Linking of Extractables and Leachables 44\u003c\/p\u003e \u003cp\u003eA Hierarchy for Linkages between Extractables and Leachables 44\u003c\/p\u003e \u003cp\u003eDecisions Concerning the Required Rigor for Linkages 47\u003c\/p\u003e \u003cp\u003eCircumstances Requiring the Linking of Extractables and Leachables 48\u003c\/p\u003e \u003cp\u003eIdentification and Quantitation 50\u003c\/p\u003e \u003cp\u003eRisks and Risk Management 55\u003c\/p\u003e \u003cp\u003eRisk Categories Related to Biological Assessment of Medical Devices 58\u003c\/p\u003e \u003cp\u003eRisk Categories Related to Assessment of Primary Packaging and\/or Container–Closure Systems 58\u003c\/p\u003e \u003cp\u003eThe General Dimensions of Risk 64\u003c\/p\u003e \u003cp\u003eUtilization of Risk Classification Profiles 68\u003c\/p\u003e \u003cp\u003eRisk Classification in Indirect Contact Situations 71\u003c\/p\u003e \u003cp\u003eThe Construct Itself as a Contributor to Risk 73\u003c\/p\u003e \u003cp\u003eReferences 74\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3. Extractables, Leachables, and the Product Life Cycle 77\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral 77\u003c\/p\u003e \u003cp\u003eDiscussion of the Components of the Master Flow Diagram 78\u003c\/p\u003e \u003cp\u003eObservations 83\u003c\/p\u003e \u003cp\u003eApplication of the Process Map 87\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart B Material Characterization 89\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4. Material Screening and Characterization 91\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eOverview 91\u003c\/p\u003e \u003cp\u003eGeneral Principles 94\u003c\/p\u003e \u003cp\u003eCompendial Compliance 97\u003c\/p\u003e \u003cp\u003eUnited States Pharmacopeia 98\u003c\/p\u003e \u003cp\u003eJapanese Pharmaceopeia 101\u003c\/p\u003e \u003cp\u003eEuropean Pharmacopeia 102\u003c\/p\u003e \u003cp\u003eCompositional Characterization, General Concepts 103\u003c\/p\u003e \u003cp\u003eCompositional Characterization by Collecting Available Material Information 104\u003c\/p\u003e \u003cp\u003eGeneral 104\u003c\/p\u003e \u003cp\u003eCollecting Extractables Information from the Material Supplier 106\u003c\/p\u003e \u003cp\u003eCompositional Characterization by Material Testing, Extractables Survey 112\u003c\/p\u003e \u003cp\u003eExtractables Survey: Extraction 112\u003c\/p\u003e \u003cp\u003eCase Studies: The Influence of Extraction Medium on the Extractables Survey 121\u003c\/p\u003e \u003cp\u003eExtractables Survey: Extract Analysis 124\u003c\/p\u003e \u003cp\u003eCase Study: Extractables Survey for Plastic Tubing Materials 131\u003c\/p\u003e \u003cp\u003eCase Study: Extractables Survey for an Elastomer Used in OINDP 136\u003c\/p\u003e \u003cp\u003eCase Study: Extractables Survey for a Rubber Closure Used with Semisolid Drug Products 137\u003c\/p\u003e \u003cp\u003eCase Study: Extractables Survey for Filter Cartridges Used in Downstream Processing of Pharmaceuticals 138\u003c\/p\u003e \u003cp\u003eBibliography of Analytical Methods 139\u003c\/p\u003e \u003cp\u003eReconciliation as a Survey Tool 140\u003c\/p\u003e \u003cp\u003eCase Study: TOC Reconciliation; Characterization of a Polyolefin Material 141\u003c\/p\u003e \u003cp\u003eUse of Extractables Information in Safety Assessment: Extractables Profile, Total Pool, and Total Available Pool 142\u003c\/p\u003e \u003cp\u003eExtractions to Establish the Total Pool and Total Available Pool 143\u003c\/p\u003e \u003cp\u003eCase Study: Total Pool Determination by Successive Extraction 145\u003c\/p\u003e \u003cp\u003eRecap: Components of a Complete Extractables Assessment 146\u003c\/p\u003e \u003cp\u003eCaveats in Using Extractables Information for Safety Assessment 149\u003c\/p\u003e \u003cp\u003eChemical Characterization: Device Perspective per ISO 10993-18 152\u003c\/p\u003e \u003cp\u003eReferences 154\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart C Construct Qualification 157\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5. The Prototype Stage 159\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral Comments 159\u003c\/p\u003e \u003cp\u003eThe Simulation Study 161\u003c\/p\u003e \u003cp\u003eGenerating the Simulating Extract 162\u003c\/p\u003e \u003cp\u003eSimulating the Contact Parameters 164\u003c\/p\u003e \u003cp\u003eSimulating the Therapeutic Product 166\u003c\/p\u003e \u003cp\u003eSimulating the Exposure Parameters 169\u003c\/p\u003e \u003cp\u003eAnalyzing the Simulating Extract 171\u003c\/p\u003e \u003cp\u003eCase Study: Modeling of the Impact of Solubilizing Agents on Leachables Accumulation 172\u003c\/p\u003e \u003cp\u003eCase Study: Accumulation of Organic Leachables from Plastic Biopharmaceutical Process Containers 174\u003c\/p\u003e \u003cp\u003eCase Study: Accumulation of Label-Related Leachables in a Solid Dosage Form 179\u003c\/p\u003e \u003cp\u003eCase Study: Accumulation of Caprolactam Oligomers Leached from Nylon-6 Material 180\u003c\/p\u003e \u003cp\u003eApplication of the Analytical Threshold 181\u003c\/p\u003e \u003cp\u003eThe Preliminary Toxicological Assessment 184\u003c\/p\u003e \u003cp\u003eCase Study: Assessment of Cyclohexanone Limits for Containers 188\u003c\/p\u003e \u003cp\u003eExiting the Prototype Stage 188\u003c\/p\u003e \u003cp\u003eReferences 189\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6. The Early Development Stage 191\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral Comments 191\u003c\/p\u003e \u003cp\u003eTarget Leachables 192\u003c\/p\u003e \u003cp\u003eMethod Development, Evaluation, and Validation 194\u003c\/p\u003e \u003cp\u003eMethod Development (Optimization) 195\u003c\/p\u003e \u003cp\u003ePrerequisites to Method Optimization 195\u003c\/p\u003e \u003cp\u003eOverview of the Method Optimization Process 197\u003c\/p\u003e \u003cp\u003eConduct of a Method Optimization Study 200\u003c\/p\u003e \u003cp\u003ePrimary Performance Assessment 201\u003c\/p\u003e \u003cp\u003eTroubleshooting Guide 202\u003c\/p\u003e \u003cp\u003eSecondary Performance Assessment 204\u003c\/p\u003e \u003cp\u003eSystem Suitability 205\u003c\/p\u003e \u003cp\u003eRobustness 205\u003c\/p\u003e \u003cp\u003eExiting Method Development–Optimization 206\u003c\/p\u003e \u003cp\u003eThe Method Evaluation Process 206\u003c\/p\u003e \u003cp\u003eGeneral 206\u003c\/p\u003e \u003cp\u003eAspects of the Evaluation and Validation Processes 207\u003c\/p\u003e \u003cp\u003eOverview of the Method Evaluation Process 207\u003c\/p\u003e \u003cp\u003eTemplate for the Conduct of a Method Evaluation Study 209\u003c\/p\u003e \u003cp\u003eValidation 214\u003c\/p\u003e \u003cp\u003eCase Study: Validation of an LC\/MS Method for the Quantitation of Leachables from a Packaging System 215\u003c\/p\u003e \u003cp\u003eGeneral 215\u003c\/p\u003e \u003cp\u003eExperimental 216\u003c\/p\u003e \u003cp\u003eValidation Study 218\u003c\/p\u003e \u003cp\u003eCase Study: Validation of an HPLC Method for Quantitating Stopper Leachables in a Complex Surfactant Vehicle 225\u003c\/p\u003e \u003cp\u003eGeneral 225\u003c\/p\u003e \u003cp\u003eValidation 225\u003c\/p\u003e \u003cp\u003eExiting the Early Development Stage 228\u003c\/p\u003e \u003cp\u003eReferences 228\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart D Construct Validation 229\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7. Late Stage Product Development 231\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral: The Migration Study 231\u003c\/p\u003e \u003cp\u003eDesign of the Migration Study 233\u003c\/p\u003e \u003cp\u003eEMEA Guideline on Plastic Immediate Packaging Materials 233\u003c\/p\u003e \u003cp\u003eFDA Guidance 233\u003c\/p\u003e \u003cp\u003eOptimal Design of a Migration Study 234\u003c\/p\u003e \u003cp\u003eInterpretation of the Migration Study: Toxicological Assessment 238\u003c\/p\u003e \u003cp\u003eDisaster Management 238\u003c\/p\u003e \u003cp\u003eClass A Disaster: Unusual or Unexpected Change in the Concentration of a Target Leachable 239\u003c\/p\u003e \u003cp\u003eClass B Disaster: A Previously Unobserved Response is Obtained During Testing 241\u003c\/p\u003e \u003cp\u003eDocumenting a Disaster Investigation 242\u003c\/p\u003e \u003cp\u003eSpecificity Check in Drug Product Analysis Methods 242\u003c\/p\u003e \u003cp\u003eProduct Stability Issues Associated with Leachables 244\u003c\/p\u003e \u003cp\u003eReferences 245\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8. Submission 249\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral Discussion 249\u003c\/p\u003e \u003cp\u003eDossier Format: The Common Technical Document 250\u003c\/p\u003e \u003cp\u003eContents of the CTD Sections Relevant to Container Closure Systems and Their Safety Assessment 252\u003c\/p\u003e \u003cp\u003eSection 3.2.P.7, Description 252\u003c\/p\u003e \u003cp\u003eSection 3.2.P.2.4, Suitability 254\u003c\/p\u003e \u003cp\u003eClosing Observations 262\u003c\/p\u003e \u003cp\u003eReferences 263\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9. Launch 265\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart E Product Maintenance 271\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10. Product Maintenance 273\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGeneral Discussion 273\u003c\/p\u003e \u003cp\u003eOngoing Quality Control 275\u003c\/p\u003e \u003cp\u003eGeneral 275\u003c\/p\u003e \u003cp\u003eIncoming Raw Materials 275\u003c\/p\u003e \u003cp\u003eManufactured In-Process Goods 278\u003c\/p\u003e \u003cp\u003eFinished Goods (Final Product) 279\u003c\/p\u003e \u003cp\u003eProcess of Developing–Implementing QC Extractables Specifications 281\u003c\/p\u003e \u003cp\u003eChange Control 282\u003c\/p\u003e \u003cp\u003eGeneral 282\u003c\/p\u003e \u003cp\u003eChange Control Impact Assessment 285\u003c\/p\u003e \u003cp\u003eEvaluation Recommendation 295\u003c\/p\u003e \u003cp\u003eFactors to Consider When Contemplating Changes to Registered Products 296\u003c\/p\u003e \u003cp\u003eCase Study: Differential Approach 297\u003c\/p\u003e \u003cp\u003eOverview 297\u003c\/p\u003e \u003cp\u003eGeneral Test Strategy 297\u003c\/p\u003e \u003cp\u003eExperimental 298\u003c\/p\u003e \u003cp\u003eResults and Discussion 299\u003c\/p\u003e \u003cp\u003ePrinciples for Judging Toxicological Equivalency 304\u003c\/p\u003e \u003cp\u003eDisaster Management During Product Maintenance 305\u003c\/p\u003e \u003cp\u003eAtypical Manufacturing During Product Maintenance 305\u003c\/p\u003e \u003cp\u003eProduct Use Field Issues Encountered During Product Maintenance 309\u003c\/p\u003e \u003cp\u003eChanges in Product Registration Requirements During Product Maintenance 312\u003c\/p\u003e \u003cp\u003eExiting the Product Maintenance Stage 313\u003c\/p\u003e \u003cp\u003eReferences 313\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11. Retirement 315\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12. Focus on Emerging Concepts 319\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eOverview 319\u003c\/p\u003e \u003cp\u003ePlastic Materials used in Manufacturing Applications 320\u003c\/p\u003e \u003cp\u003eGeneral 320\u003c\/p\u003e \u003cp\u003eRegulatory Requirements 321\u003c\/p\u003e \u003cp\u003eIndustry Recommendations 322\u003c\/p\u003e \u003cp\u003eCase Study: Leachables Evaluation for Bulk Drug Substance 326\u003c\/p\u003e \u003cp\u003eProcess for Performing Extractables and Leachables Assessments for Disposable Materials Used in Bioprocessing 327\u003c\/p\u003e \u003cp\u003eA Matter of Semantics 328\u003c\/p\u003e \u003cp\u003eBest Demonstrated Practices in Extractables Assessments 331\u003c\/p\u003e \u003cp\u003eThe Broader Context of Suitability for Use 337\u003c\/p\u003e \u003cp\u003eAn Important Practical Consideration 340\u003c\/p\u003e \u003cp\u003eFuture Considerations 342\u003c\/p\u003e \u003cp\u003eReferences 344\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix: Materials Used in Pharmaceutical Constructs and Their Associated Extractables 347\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eReferences 370\u003c\/p\u003e \u003cp\u003eIndex 371\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49402312524119,"sku":"9780470281765","price":109.76,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470281765.jpg?v=1730480032","url":"https:\/\/bookcurl.com\/products\/compatibility-of-pharmaceutical-solutions-and-contact-materials-9780470281765","provider":"Book Curl","version":"1.0","type":"link"}