{"product_id":"pharmaceutical-dissolution-testing-bioavailability-and-bioequivalence-9781119634607","title":"Pharmaceutical Dissolution Testing","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003eExplore the cutting-edge of dissolution testing in an authoritative, one-stop resource\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eIn \u003ci\u003ePharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond\u003c\/i\u003e, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development.\u003c\/p\u003e \u003cp\u003eAfter discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle.\u003c\/p\u003e \u003cp\u003eOver 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety.\u003c\/p\u003e \u003cp\u003eThis volume offers a one-stop resourc\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eForeword xvii\u003c\/p\u003e \u003cp\u003eForeword xix\u003c\/p\u003e \u003cp\u003ePreface xxi\u003c\/p\u003e \u003cp\u003eAcknowledgments xxvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Pharmaceutical Dissolution Testing: Fundamentals and Essential Applications (An Overview) 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction and Objective(s) 1\u003c\/p\u003e \u003cp\u003e1.2 Science of Dissolution Over Past 120+ Years 3\u003c\/p\u003e \u003cp\u003e1.2.1 Journey from Quality Control (QC) to Development 5\u003c\/p\u003e \u003cp\u003e1.3 Fundamentals of Dissolution Testing (An Overview) 6\u003c\/p\u003e \u003cp\u003e1.4 Factors Influencing Dissolution Test(ing) 8\u003c\/p\u003e \u003cp\u003e1.5 Pharmaceutical Product Life Cycle: Role of Dissolution (An Overview) 12\u003c\/p\u003e \u003cp\u003e1.6 Dissolution Test(ing): What It Is and What It Is Not! 13\u003c\/p\u003e \u003cp\u003e1.7 Need for This Textbook 14\u003c\/p\u003e \u003cp\u003e1.8 Summary and Concluding Remarks 15\u003c\/p\u003e \u003cp\u003eReferences 16\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Bioavailability (BA) and Bioequivalence (BE): Fundamentals and Applications in Drug Product Development 20\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction and Objective(s) 20\u003c\/p\u003e \u003cp\u003e2.2 Definitions 21\u003c\/p\u003e \u003cp\u003e2.3 Bioequivalence (BE) Testing: Basics, Advances, and Global Perspectives 23\u003c\/p\u003e \u003cp\u003e2.3.1 BA\/BE Study Designs 26\u003c\/p\u003e \u003cp\u003e2.3.2 Sample Size, n 28\u003c\/p\u003e \u003cp\u003e2.3.3 BE (Acceptance) Criteria and Statistical Considerations 31\u003c\/p\u003e \u003cp\u003e2.3.4 Bioequivalence (BE) Studies: Role of Modeling and Simulations 33\u003c\/p\u003e \u003cp\u003e2.3.5 Surrogates to BE 35\u003c\/p\u003e \u003cp\u003e2.3.6 PD Endpoint-Based and Clinical Endpoint-Based BE Assessment 37\u003c\/p\u003e \u003cp\u003e2.3.7 Regulatory Requirements 40\u003c\/p\u003e \u003cp\u003e2.4 Current Challenges and Solutions (Insight into Chapter 14) 43\u003c\/p\u003e \u003cp\u003e2.5 Summary and Concluding Remarks 44\u003c\/p\u003e \u003cp\u003eReferences 44\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Solubility, Dissolution, Permeability, and Classification Systems 54\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction and Objective(s) 54\u003c\/p\u003e \u003cp\u003e3.2 Definitions 56\u003c\/p\u003e \u003cp\u003e3.3 Solubility Versus Solubilization: What Is Critical in Development? 58\u003c\/p\u003e \u003cp\u003e3.3.1 Theories of Solubilization 58\u003c\/p\u003e \u003cp\u003e3.3.2 Solubility: Challenges in Drug Development! 63\u003c\/p\u003e \u003cp\u003e3.3.3 Solubility Enhancement: Purpose, Theoretical and Practical Considerations! 68\u003c\/p\u003e \u003cp\u003e3.4 Dissolution: Intrinsic Versus Apparent! 70\u003c\/p\u003e \u003cp\u003e3.4.1 Theories of Dissolution 70\u003c\/p\u003e \u003cp\u003e3.4.1.1 Noyes–Whitney Theory (1897) 70\u003c\/p\u003e \u003cp\u003e3.4.1.2 Brunner and Tolloczko Theory (1900) 71\u003c\/p\u003e \u003cp\u003e3.4.1.3 Nernst and Brunner Theory (1904) 71\u003c\/p\u003e \u003cp\u003e3.4.2 Intrinsic Versus Apparent Dissolution 72\u003c\/p\u003e \u003cp\u003e3.5 Permeability Versus Permeation (Process): What Is Critical for Bioefficacy! 74\u003c\/p\u003e \u003cp\u003e3.6 Classification Systems: Theoretical Versus Pragmatic Considerations! 75\u003c\/p\u003e \u003cp\u003e3.7 Summary and Concluding Remarks 78\u003c\/p\u003e \u003cp\u003eReferences 79\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Understanding the Mechanics of Dissolution: Mathematical Models and Simulations 86\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction and Objective(s) 86\u003c\/p\u003e \u003cp\u003e4.2 Mechanics of Dissolution: Theories, Presumptions, and Reality Check 87\u003c\/p\u003e \u003cp\u003e4.3 Dissolution Theories\/Models 91\u003c\/p\u003e \u003cp\u003e4.4 Dissolution Mechanics (Model-Dependent Methods) 92\u003c\/p\u003e \u003cp\u003e4.4.1 Zero Order 92\u003c\/p\u003e \u003cp\u003e4.4.2 First-Order Model (Gibaldi–Feldman Model 1967) 93\u003c\/p\u003e \u003cp\u003e4.4.3 Makoid–Banakar Model (1993) 93\u003c\/p\u003e \u003cp\u003e4.4.4 Hixson and Crowell Model (1931) 95\u003c\/p\u003e \u003cp\u003e4.4.5 Higuchi Model (1961, 1963, 1967) 96\u003c\/p\u003e \u003cp\u003e4.4.6 Baker–Lonsdale (1974) 97\u003c\/p\u003e \u003cp\u003e4.4.7 Korsmeyer–Peppas Model (1983) 98\u003c\/p\u003e \u003cp\u003e4.4.8 Hopfenberg Model (1976) 98\u003c\/p\u003e \u003cp\u003e4.4.9 Gompertz Distribution Model 99\u003c\/p\u003e \u003cp\u003e4.4.10 El-Yazigi Model (1981) 100\u003c\/p\u003e \u003cp\u003e4.5 Dissolution Mechanics (Model-Independent Methods) 101\u003c\/p\u003e \u003cp\u003e4.5.1 Weibull Distribution Model (1951) 101\u003c\/p\u003e \u003cp\u003e4.5.2 Statistical Mean Time Concept\/Model (1982) 101\u003c\/p\u003e \u003cp\u003e4.5.3 (Other) Statistical Regression-Based Models 102\u003c\/p\u003e \u003cp\u003e4.5.4 Sequential Model 102\u003c\/p\u003e \u003cp\u003e4.5.5 Density Function Theory (DFT) 103\u003c\/p\u003e \u003cp\u003e4.6 Relevance of Mathematical Modeling of Dissolution 104\u003c\/p\u003e \u003cp\u003e4.7 Purposeful Modeling and Simulation 105\u003c\/p\u003e \u003cp\u003e4.8 Summary and Concluding Remarks 106\u003c\/p\u003e \u003cp\u003eReferences 107\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Dissolution Testing Methods: Necessity Is the Mother of Invention! 110\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction and Objective(s) 110\u003c\/p\u003e \u003cp\u003e5.2 Need for Dissolution Testing Method 112\u003c\/p\u003e \u003cp\u003e5.3 Dissolution Testing Methods 113\u003c\/p\u003e \u003cp\u003e5.3.1 Science of Dissolution 114\u003c\/p\u003e \u003cp\u003e5.3.2 Intrinsic and Apparent Dissolution Methods 116\u003c\/p\u003e \u003cp\u003e5.3.3 Compendial Methods Versus Regulatory Perspective 120\u003c\/p\u003e \u003cp\u003e5.3.4 Predictive Testing Methods and “Biorelevant Dissolution” Methods 124\u003c\/p\u003e \u003cp\u003e5.4 Necessity Is the Mother of Invention! 137\u003c\/p\u003e \u003cp\u003e5.4.1 Controlled Release Parenteral Systems Including Drug-Eluting Stents 138\u003c\/p\u003e \u003cp\u003e5.4.2 Pharmaceutical Formulations for the Oral Cavity 139\u003c\/p\u003e \u003cp\u003e5.4.2.1 Soft Gelatin Capsules (SGC): Oral Delivery and Rectal Inserts 144\u003c\/p\u003e \u003cp\u003e5.4.3 Inhalation Products 145\u003c\/p\u003e \u003cp\u003e5.4.4 Semisolid Pharmaceutical Systems Including Transdermal Drug Delivery Systems (TDDSs) 148\u003c\/p\u003e \u003cp\u003e5.4.5 Nanotechnology-Based Systems: Nanobiomedicine Formulations 149\u003c\/p\u003e \u003cp\u003e5.4.6 Others 150\u003c\/p\u003e \u003cp\u003e5.5 The Perpetual Struggle 152\u003c\/p\u003e \u003cp\u003e5.6 Concluding Remarks 154\u003c\/p\u003e \u003cp\u003eReferences 155\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Essentials of Dissolution Testing of Pharmaceutical Systems 166\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction and Objective(s) 166\u003c\/p\u003e \u003cp\u003e6.2 Objectives of Dissolution Testing of Pharmaceutical Systems 167\u003c\/p\u003e \u003cp\u003e6.3 Oral Solid Dosage Forms (SDFs) 168\u003c\/p\u003e \u003cp\u003e6.3.1 Immediate Release\/Rapid Release SDFs 170\u003c\/p\u003e \u003cp\u003e6.3.1.1 Conventional IR SDFs (Focus: Recent Advances in Solubility Enhancement!) 171\u003c\/p\u003e \u003cp\u003e6.3.1.2 Chewable: Tablets and Gums 175\u003c\/p\u003e \u003cp\u003e6.3.2 Modified Release (MR) SDFs 179\u003c\/p\u003e \u003cp\u003e6.3.3 Advanced\/Innovative MR-SDFs 193\u003c\/p\u003e \u003cp\u003e6.4 Oral Liquid Dosage Forms 197\u003c\/p\u003e \u003cp\u003e6.4.1 Rapid Release Systems (RRSs) 198\u003c\/p\u003e \u003cp\u003e6.5 Non-oral Dosage Forms 201\u003c\/p\u003e \u003cp\u003e6.5.1 Topical Dosage Forms 202\u003c\/p\u003e \u003cp\u003e6.5.1.1 Traditional Topical Dosage Forms 203\u003c\/p\u003e \u003cp\u003e6.5.1.2 Transdermal Drug Delivery Systems 204\u003c\/p\u003e \u003cp\u003e6.5.1.3 Nasal, Ocular, Otic, Vaginal, and Rectal Dosage Forms 205\u003c\/p\u003e \u003cp\u003e6.5.2 Parenteral Dosage Forms 213\u003c\/p\u003e \u003cp\u003e6.6 Nanotechnology-Based Pharmaceutical Systems 220\u003c\/p\u003e \u003cp\u003e6.7 Nutraceuticals and Natural Products 221\u003c\/p\u003e \u003cp\u003e6.8 Concluding Remarks: Need for Purposeful Dissolution\/Release Testing! 225\u003c\/p\u003e \u003cp\u003eReferences 226\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Dissolution\/Release Test Data (Profile): Requirements, Analyses, and Regulatory Expectations 237\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction and Objective(s) 237\u003c\/p\u003e \u003cp\u003e7.2 Academic Curiosity 239\u003c\/p\u003e \u003cp\u003e7.3 Early Development 241\u003c\/p\u003e \u003cp\u003e7.4 Product Development Stage 242\u003c\/p\u003e \u003cp\u003e7.5 Comparative Analyses 244\u003c\/p\u003e \u003cp\u003e7.6 Summary and Concluding Remarks 248\u003c\/p\u003e \u003cp\u003eReferences 250\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Automation in Dissolution Testing: Recent Advances and Continuing Challenges! 254\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction and Objective(s) 254\u003c\/p\u003e \u003cp\u003e8.2 Automated Dissolution Testing: Why and What to Automate? 255\u003c\/p\u003e \u003cp\u003e8.3 Challenges in Automation of Dissolution Test(ing) 263\u003c\/p\u003e \u003cp\u003e8.4 Automation in Dissolution Testing: Looking Forward! 264\u003c\/p\u003e \u003cp\u003e8.5 Concluding Remarks 266\u003c\/p\u003e \u003cp\u003eReferences 267\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 In vitro–In vivo Correlations (IVIVCs): What Makes Them Challenging! 269\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction and Objective(S) 269\u003c\/p\u003e \u003cp\u003e9.2 Basic Model, Scheme, and Assumptions 270\u003c\/p\u003e \u003cp\u003e9.3 Mechanics for Determination of IVIVC 277\u003c\/p\u003e \u003cp\u003e9.4 BCS and IVIVC 280\u003c\/p\u003e \u003cp\u003e9.5 IVIVC in New Drug Development vis-à-vis Generic Drug Development 283\u003c\/p\u003e \u003cp\u003e9.6 IVIVCs in Topical\/Transdermal Drug Delivery Systems (TDDSs) 284\u003c\/p\u003e \u003cp\u003e9.7 Nonlinear IVIVCs 286\u003c\/p\u003e \u003cp\u003e9.8 Validation of IVIVC Prediction Error (PE) 286\u003c\/p\u003e \u003cp\u003e9.9 IVIVC in Drug Product Life Cycle: What Is the Ultimate Objective? 287\u003c\/p\u003e \u003cp\u003e9.10 Summary and Conclusions 289\u003c\/p\u003e \u003cp\u003eReferences 289\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Biorelevant Dissolution\/Release Test Method Development for Pharmaceutical Dosage Forms 294\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction and Objective(s) 294\u003c\/p\u003e \u003cp\u003e10.2 General Considerations in BDM Development 295\u003c\/p\u003e \u003cp\u003e10.3 Oral Drug Delivery Systems 296\u003c\/p\u003e \u003cp\u003e10.3.1 Challenges in the Simulation of GI Biorelevant Factors: Motility and Hydrodynamics 299\u003c\/p\u003e \u003cp\u003e10.3.2 Biorelevant Dissolution Media for Oral Drug Delivery Systems 301\u003c\/p\u003e \u003cp\u003e10.4 Inhalation Drug Delivery Systems 303\u003c\/p\u003e \u003cp\u003e10.5 Parenteral Drug Delivery Systems 306\u003c\/p\u003e \u003cp\u003e10.6 Other Drug Delivery Systems 308\u003c\/p\u003e \u003cp\u003e10.7 The Roadmap 309\u003c\/p\u003e \u003cp\u003e10.8 Summary and Concluding Remarks 310\u003c\/p\u003e \u003cp\u003eReferences 311\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Bioavailability Prediction Software: Hype or Reality! 320\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction and Objective(s) 320\u003c\/p\u003e \u003cp\u003e11.2 The Need for Simulations and Predictions in Drug Product Development 322\u003c\/p\u003e \u003cp\u003e11.3 Simulation and Prediction of In Vivo Performance: The Catch- 22 Situation!325\u003c\/p\u003e \u003cp\u003e11.4 Bioavailability (BA)\/Bioequivalence (BE) Simulation Software: What They Do and Do Not! 327\u003c\/p\u003e \u003cp\u003e11.5 Appreciating and Depreciating Potential Utility of BA Prediction Software 335\u003c\/p\u003e \u003cp\u003e11.6 Concluding Remarks 336\u003c\/p\u003e \u003cp\u003eReferences 337\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Challenges and Unique Applications of IVIVC in Drug Development 340\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction and Objective(s) 340\u003c\/p\u003e \u003cp\u003e12.2 USP \u0026lt;1088\u0026gt; and US FDA Guidance for Industry (1997): Operational Challenges 342\u003c\/p\u003e \u003cp\u003e12.3 Applications of IVIVC(s) 347\u003c\/p\u003e \u003cp\u003e12.4 Prospective IVIVC(s) 349\u003c\/p\u003e \u003cp\u003e12.4.1 Background 349\u003c\/p\u003e \u003cp\u003e12.4.2 Process 349\u003c\/p\u003e \u003cp\u003e12.4.3 Application 352\u003c\/p\u003e \u003cp\u003e12.4.3.1 Unique Application of IVIVC 353\u003c\/p\u003e \u003cp\u003e12.5 Retrospective IVIVC(s): Responding to Agency Queries! 355\u003c\/p\u003e \u003cp\u003e12.6 Summary and Concluding Remarks 361\u003c\/p\u003e \u003cp\u003eReferences 362\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Dissolution Testing in Generic Drug Development: Methods, Requirements, and Regulatory Expectations\/Requirements 366\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction and Objective(s) 366\u003c\/p\u003e \u003cp\u003e13.2 Generic Drug Development Process: Role of Dissolution Testing 368\u003c\/p\u003e \u003cp\u003e13.2.1 Preformulation 369\u003c\/p\u003e \u003cp\u003e13.2.2 Prototype Formulation 371\u003c\/p\u003e \u003cp\u003e13.2.3 Prospective Development: IVIVC with BE as the Objective! 372\u003c\/p\u003e \u003cp\u003e13.2.4 Pilot BE to Pivotal BE 375\u003c\/p\u003e \u003cp\u003e13.3 Generic Pharmaceutical Systems: Role of Dissolution 375\u003c\/p\u003e \u003cp\u003e13.3.1 Traditional: Para III Formulations – Rush to “First to File” 376\u003c\/p\u003e \u003cp\u003e13.3.2 Para IV Formulations 377\u003c\/p\u003e \u003cp\u003e13.3.3 Exploring 505(b)(2) Opportunities 380\u003c\/p\u003e \u003cp\u003e13.3.4 Differentiated Products and\/or Incremental Innovations 384\u003c\/p\u003e \u003cp\u003e13.3.5 Supergenerics: Are They? 385\u003c\/p\u003e \u003cp\u003e13.3.6 Complex Generics 386\u003c\/p\u003e \u003cp\u003e13.4 Generics: Finished Products – Role of Dissolution Testing 388\u003c\/p\u003e \u003cp\u003e13.4.1 Tentative Approval to Final Approval: Setting QC Specifications! 388\u003c\/p\u003e \u003cp\u003e13.4.2 Biowaivers: Global Considerations and Perspectives! 389\u003c\/p\u003e \u003cp\u003e13.4.3 Regulatory Queries and Responses 392\u003c\/p\u003e \u003cp\u003e13.5 Summary and Concluding Remarks 396\u003c\/p\u003e \u003cp\u003eReferences 396\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Successful Bioequivalence Investigations: Current Challenges and Possible Solutions! 400\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction and Objective(s) 400\u003c\/p\u003e \u003cp\u003e14.2 Understanding Challenges and Approaches to Overcome Them! 402\u003c\/p\u003e \u003cp\u003e14.2.1 Oral Dosage Forms 404\u003c\/p\u003e \u003cp\u003e14.2.1.1 Highly Variable Drugs (HVDs) 405\u003c\/p\u003e \u003cp\u003e14.2.1.2 Oral Dosage Forms: Locally Acting 406\u003c\/p\u003e \u003cp\u003e14.2.2 Narrow Therapeutic Index (NTI) Drugs 409\u003c\/p\u003e \u003cp\u003e14.2.3 Topical Dosage Forms 411\u003c\/p\u003e \u003cp\u003e14.2.3.1 Ophthalmic Dosage Forms 413\u003c\/p\u003e \u003cp\u003e14.2.4 Oral Inhalation Products 417\u003c\/p\u003e \u003cp\u003e14.2.5 Complex Generics 420\u003c\/p\u003e \u003cp\u003e14.2.6 Nutraceuticals and Natural Products 422\u003c\/p\u003e \u003cp\u003e14.3 Concluding Remarks 423\u003c\/p\u003e \u003cp\u003eReferences 424\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Beyond Guidance(s): Convincing Regulatory Authorities Through Creative Dissolution Data Interpretation 434\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction and Objective(s) 434\u003c\/p\u003e \u003cp\u003e15.2 Regulatory Guidance(s): Reading Versus Understanding! 435\u003c\/p\u003e \u003cp\u003e15.3 Regulatory Submission: Premise and Expectation(s) 438\u003c\/p\u003e \u003cp\u003e15.4 Handling Regulatory Query\/Deficiency: Efficient and Satisfying Response 440\u003c\/p\u003e \u003cp\u003e15.5 Winning an Argument: Three Cs to Succeed! 443\u003c\/p\u003e \u003cp\u003e15.6 Sample Case Study(ies) 444\u003c\/p\u003e \u003cp\u003e15.7 Summary and Concluding Remarks 447\u003c\/p\u003e \u003cp\u003eReferences 447\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Biosimilars: The Emerging Frontier for Generics – Role of Dissolution Testing! 449\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction and Objective(s) 449\u003c\/p\u003e \u003cp\u003e16.2 Generics, (Bio)betters, and Biosimilars: What Are They? 451\u003c\/p\u003e \u003cp\u003e16.3 Regulatory Approval Process (Brief): Focus on Efficacy! 453\u003c\/p\u003e \u003cp\u003e16.4 Role of Solubility and Dissolution 456\u003c\/p\u003e \u003cp\u003e16.5 Concluding Remarks 458\u003c\/p\u003e \u003cp\u003eReferences 459\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Patentability of Drug Product Based on Dissolution Data: Intellectual Property Considerations! 461\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction and Objective(s) 461\u003c\/p\u003e \u003cp\u003e17.2 Patentability and the Patent Process (Brief): Scientist’s Perspective 462\u003c\/p\u003e \u003cp\u003e17.2.1 Is Solubility and Dissolution Patentable: Scientist’s Perspective 465\u003c\/p\u003e \u003cp\u003e17.3 Pharmaceutical Product: Patentability and Role of Dissolution Testing 466\u003c\/p\u003e \u003cp\u003e17.4 Patentability: Double-Edged Sword! 468\u003c\/p\u003e \u003cp\u003e17.5 Concluding Remarks 471\u003c\/p\u003e \u003cp\u003eReferences 471\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Setting Up Clinical Therapeutics Safety-Based QC Specifications for Dissolution Testing of a Finished Product 473\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction and Objective(s) 473\u003c\/p\u003e \u003cp\u003e18.2 Critical Quality Attributes (CQA): Role of In vitro Dissolution as a QC Test! 475\u003c\/p\u003e \u003cp\u003e18.3 Clinical Drug Product Performance: Adequate or Predictable! 476\u003c\/p\u003e \u003cp\u003e18.4 Clinically Relevant Specifications (CRS): Basics and Challenges! 478\u003c\/p\u003e \u003cp\u003e18.4.1 Setting Up CRDS or CRS 481\u003c\/p\u003e \u003cp\u003e18.5 Idealism and Pragmatism Versus Realism! 484\u003c\/p\u003e \u003cp\u003e18.6 Concluding Remarks 489\u003c\/p\u003e \u003cp\u003eReferences 490\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Unlocking the Mystery(ies) While Predicting Bioavailability from Dissolution 493\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction and Objective(s) 493\u003c\/p\u003e \u003cp\u003e19.2 The IVIVC Model and Objective(s) of IVIVC 494\u003c\/p\u003e \u003cp\u003e19.3 Challenges Encountered in Predicting Bioavailability from Dissolution 495\u003c\/p\u003e \u003cp\u003e19.4 What Are We Doing Now? 499\u003c\/p\u003e \u003cp\u003e19.4.1 Mathematical Modeling: Limitations and Feel Good Phenomena! 499\u003c\/p\u003e \u003cp\u003e19.4.2 BCS and Its Relation to Drug Formulation’s Dissolution Performance 500\u003c\/p\u003e \u003cp\u003e19.4.3 The Application (or the Lack) of f 1 and f 2 Parameters 501\u003c\/p\u003e \u003cp\u003e19.4.4 Dissolution Data Banks, Agency Recommendations, and Compendial Monographs 502\u003c\/p\u003e \u003cp\u003e19.4.5 Dissolution Testing Apparatuses (Choice Versus Selection!) 503\u003c\/p\u003e \u003cp\u003e19.4.6 Advent of Biophysiologically Relevant Dissolution Media(um) 504\u003c\/p\u003e \u003cp\u003e19.4.7 What Are We Missing in This Picture? 505\u003c\/p\u003e \u003cp\u003e19.5 What We Should Be Doing! The Way Forward: The Missing Link! 506\u003c\/p\u003e \u003cp\u003e19.6 Advent of IVRT, IVPT, PBPK, and PBAM 508\u003c\/p\u003e \u003cp\u003e19.6.1 Role of IVRT, IVPT, and PBAM in Predicting In Vivo Absorption of Drug from Oral Solid Dosage Forms 510\u003c\/p\u003e \u003cp\u003e19.7 Summary and Concluding Remarks 511\u003c\/p\u003e \u003cp\u003eReferences 512\u003c\/p\u003e \u003cp\u003eIndex 515\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49407105237335,"sku":"9781119634607","price":146.66,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781119634607.jpg?v=1730498193","url":"https:\/\/bookcurl.com\/products\/pharmaceutical-dissolution-testing-bioavailability-and-bioequivalence-9781119634607","provider":"Book Curl","version":"1.0","type":"link"}