{"product_id":"integrated-pharmaceutics-applied-preformulation-product-design-and-regulatory-science-2nd-edition-9781119574699","title":"Integrated Pharmaceutics  Applied Preformulation  Product Design and Regulatory Science 2nd Edition","description":"\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eForeword to Second Edition xv\u003c\/p\u003e \u003cp\u003eForeword to First Edition xvi\u003c\/p\u003e \u003cp\u003ePreface to Second Edition xvii\u003c\/p\u003e \u003cp\u003ePreface to First Edition xviii\u003c\/p\u003e \u003cp\u003eAbout the Companion Website xx\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Applied Preformulation \u003c\/b\u003e\u003cb\u003e1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Mathematical Concepts \u003c\/b\u003e\u003cb\u003e3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 3\u003c\/p\u003e \u003cp\u003e1.2 Significant Figures and Rounding off Numbers 3\u003c\/p\u003e \u003cp\u003e1.3 The Simple Linear Relationship 4\u003c\/p\u003e \u003cp\u003e1.4 Exponential Rules 6\u003c\/p\u003e \u003cp\u003e1.5 Logarithmic Rules 6\u003c\/p\u003e \u003cp\u003e1.6 Differential Equations 7\u003c\/p\u003e \u003cp\u003e1.7 Expanding and Reducing Formulas 9\u003c\/p\u003e \u003cp\u003e1.8 Weights and Measures 9\u003c\/p\u003e \u003cp\u003eReferences 10\u003c\/p\u003e \u003cp\u003eGlossary 10\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Thermodynamics \u003c\/b\u003e\u003cb\u003e11\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 11\u003c\/p\u003e \u003cp\u003e2.2 The Zeroth Law of Thermodynamics 11\u003c\/p\u003e \u003cp\u003e2.3 The First Law of Thermodynamics 11\u003c\/p\u003e \u003cp\u003e2.4 The Second Law of Thermodynamics 12\u003c\/p\u003e \u003cp\u003e2.5 The Third Law of Thermodynamics 13\u003c\/p\u003e \u003cp\u003e2.6 Polymorphism 13\u003c\/p\u003e \u003cp\u003e2.7 Physical Stability of Crystal Forms 14\u003c\/p\u003e \u003cp\u003e2.8 Solubility 14\u003c\/p\u003e \u003cp\u003eReferences 15\u003c\/p\u003e \u003cp\u003eGlossary 16\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Solubility and Dissolution \u003c\/b\u003e\u003cb\u003e18\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 18\u003c\/p\u003e \u003cp\u003e3.2 Methods of API Solubility Enhancement 19\u003c\/p\u003e \u003cp\u003e3.3 Nonionic, Ionic, and Acid–Base Concepts Related to Solubility and Dissolution 29\u003c\/p\u003e \u003cp\u003e3.4 The Solubility of Gas in Liquid 29\u003c\/p\u003e \u003cp\u003e3.5 The Solubility of Liquid in Liquid 30\u003c\/p\u003e \u003cp\u003e3.6 The Solubility of Solid in Liquid 30\u003c\/p\u003e \u003cp\u003e3.7 Disintegration and Dissolution 31\u003c\/p\u003e \u003cp\u003e3.8 Concentration Units 34\u003c\/p\u003e \u003cp\u003e3.9 The Partition Coefficient 39\u003c\/p\u003e \u003cp\u003e3.10 Concluding Remarks 41\u003c\/p\u003e \u003cp\u003eReferences 41\u003c\/p\u003e \u003cp\u003eGlossary 44\u003c\/p\u003e \u003cp\u003eAppendix 45\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Biological Aspects of Formulations \u003c\/b\u003e\u003cb\u003e46\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 46\u003c\/p\u003e \u003cp\u003e4.2 Bioavailability and Bioequivalence 46\u003c\/p\u003e \u003cp\u003e4.3 Protocols for Determining Bioequivalence 48\u003c\/p\u003e \u003cp\u003e4.4 Bioequivalence Procedure 49\u003c\/p\u003e \u003cp\u003e4.5 FDA-Approved Methods for Bioequivalence Studies 49\u003c\/p\u003e \u003cp\u003e4.6 Approaches to Improving Bioavailability 50\u003c\/p\u003e \u003cp\u003eReferences 52\u003c\/p\u003e \u003cp\u003eGlossary 53\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Interfacial Properties \u003c\/b\u003e\u003cb\u003e54\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 54\u003c\/p\u003e \u003cp\u003e5.2 Liquid–Solid Interface 54\u003c\/p\u003e \u003cp\u003e5.3 Liquid–Liquid Interface 55\u003c\/p\u003e \u003cp\u003e5.4 Dosage-Form Applications 55\u003c\/p\u003e \u003cp\u003e5.5 Case Study: HLB Determination 58\u003c\/p\u003e \u003cp\u003e5.6 Case Study: Determination of Required HLB (rHLB) 58\u003c\/p\u003e \u003cp\u003eReferences 58\u003c\/p\u003e \u003cp\u003eGlossary 59\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Adsorption Phenomenon \u003c\/b\u003e\u003cb\u003e60\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 60\u003c\/p\u003e \u003cp\u003e6.2 Adsorption on Filters 66\u003c\/p\u003e \u003cp\u003e6.3 Adsorption of Proteins 66\u003c\/p\u003e \u003cp\u003eReferences 66\u003c\/p\u003e \u003cp\u003eGlossary 68\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Rheological Principles \u003c\/b\u003e\u003cb\u003e69\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 69\u003c\/p\u003e \u003cp\u003e7.2 Newtonian Systems 69\u003c\/p\u003e \u003cp\u003e7.3 Non-Newtonian Systems 70\u003c\/p\u003e \u003cp\u003e7.4 Viscoelasticity 72\u003c\/p\u003e \u003cp\u003e7.5 Reynolds Number 74\u003c\/p\u003e \u003cp\u003e7.6 Concluding Remarks 76\u003c\/p\u003e \u003cp\u003eReferences 76\u003c\/p\u003e \u003cp\u003eGlossary 77\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Chemical Stability and Shelf-Life Determination \u003c\/b\u003e\u003cb\u003e78\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 78\u003c\/p\u003e \u003cp\u003e8.2 Shelf-Life Determination 79\u003c\/p\u003e \u003cp\u003e8.3 Stability of Biotechnology Products 84\u003c\/p\u003e \u003cp\u003e8.4 Compounded Products and Their Beyond-Use Dates 86\u003c\/p\u003e \u003cp\u003eReferences 102\u003c\/p\u003e \u003cp\u003eGlossary 107\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Particle Science \u003c\/b\u003e\u003cb\u003e108\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 108\u003c\/p\u003e \u003cp\u003e9.2 Miromeritics 108\u003c\/p\u003e \u003cp\u003e9.3 Micronization 113\u003c\/p\u003e \u003cp\u003e9.4 Particle Size Preparation and Reduction for Pulmonary Delivery 114\u003c\/p\u003e \u003cp\u003e9.5 Polymeric Particulate Matter 115\u003c\/p\u003e \u003cp\u003e9.6 Nanoparticles 116\u003c\/p\u003e \u003cp\u003e9.7 Segregation of Particles 121\u003c\/p\u003e \u003cp\u003e9.8 Case Studies: Microscopic Particle Size Analysis, Determining Statistically Valid Sample Size, and Comparison of Sieve and Focused Beam Reflectance Measurement Chord Length Particle Size Distributions 122\u003c\/p\u003e \u003cp\u003eReferences 126\u003c\/p\u003e \u003cp\u003eGlossary 129\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Basic Statistics and Design of Experimental Concepts \u003c\/b\u003e\u003cb\u003e130\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Descriptive Statistics 130\u003c\/p\u003e \u003cp\u003e10.2 Inferential Statistics 131\u003c\/p\u003e \u003cp\u003e10.3 Statistical Applications in Quality Control Testing 135\u003c\/p\u003e \u003cp\u003e10.4 Design of Experiment 136\u003c\/p\u003e \u003cp\u003e10.5 Multivariate Analysis (MVA) 140\u003c\/p\u003e \u003cp\u003e10.6 Reliability and Validity Assessment 152\u003c\/p\u003e \u003cp\u003eReferences 155\u003c\/p\u003e \u003cp\u003eGlossary 155\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Formulation Development Concepts \u003c\/b\u003e\u003cb\u003e157\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Preformulation 157\u003c\/p\u003e \u003cp\u003e11.2 Scale-up Considerations 164\u003c\/p\u003e \u003cp\u003e11.3 Combination Products 168\u003c\/p\u003e \u003cp\u003e11.4 Rate-Controlled Drug Delivery 170\u003c\/p\u003e \u003cp\u003e11.5 Drug Delivery Technologies for Improving Oral Delivery 172\u003c\/p\u003e \u003cp\u003e11.6 Drug Delivery Technologies for Improving Transmucosal Delivery 173\u003c\/p\u003e \u003cp\u003e11.7 Drug Delivery Technologies for Transdermal Delivery 173\u003c\/p\u003e \u003cp\u003e11.8 Special Considerations for Biotechnology and Protein Delivery Systems 174\u003c\/p\u003e \u003cp\u003e11.9 Drug–Excipient and Excipient–Excipient Interactions 177\u003c\/p\u003e \u003cp\u003e11.10 The Presence of Contaminants in a Formulation 178\u003c\/p\u003e \u003cp\u003e11.11 Other Considerations 179\u003c\/p\u003e \u003cp\u003eReferences 179\u003c\/p\u003e \u003cp\u003eGlossary 184\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Product Design \u003c\/b\u003e\u003cb\u003e187\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 The Product Design Process \u003c\/b\u003e\u003cb\u003e189\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 189\u003c\/p\u003e \u003cp\u003e12.2 Formulation Design 191\u003c\/p\u003e \u003cp\u003e12.3 Process Design 194\u003c\/p\u003e \u003cp\u003e12.4 Container Closure System Design 195\u003c\/p\u003e \u003cp\u003eReferences 196\u003c\/p\u003e \u003cp\u003eGlossary 198\u003c\/p\u003e \u003cp\u003e12.A Appendix 199\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Tablet Product Design \u003c\/b\u003e\u003cb\u003e214\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 214\u003c\/p\u003e \u003cp\u003e13.2 Formulation Design 220\u003c\/p\u003e \u003cp\u003e13.3 Process Design 225\u003c\/p\u003e \u003cp\u003e13.4 Container Closure System Design 249\u003c\/p\u003e \u003cp\u003e13.5 Risk Management 255\u003c\/p\u003e \u003cp\u003e13.6 Attribute Tests 256\u003c\/p\u003e \u003cp\u003e13.7 New Drug Application Stability Assessment 257\u003c\/p\u003e \u003cp\u003eReferences 259\u003c\/p\u003e \u003cp\u003eGlossary 264\u003c\/p\u003e \u003cp\u003e13.A Appendix 265\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Capsule Product Design \u003c\/b\u003e\u003cb\u003e274\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 274\u003c\/p\u003e \u003cp\u003e14.2 Hard-Shell Capsules 274\u003c\/p\u003e \u003cp\u003e14.3 Soft-Shell Capsules 288\u003c\/p\u003e \u003cp\u003e14.4 Formulation and Process Optimization 291\u003c\/p\u003e \u003cp\u003e14.5 Container Closure System Design 292\u003c\/p\u003e \u003cp\u003e14.6 Risk Management 292\u003c\/p\u003e \u003cp\u003e14.7 Attribute Tests 292\u003c\/p\u003e \u003cp\u003e14.8 New Drug Application Stability Assessment 293\u003c\/p\u003e \u003cp\u003eReferences 293\u003c\/p\u003e \u003cp\u003eGlossary 295\u003c\/p\u003e \u003cp\u003e14.A Appendix 296\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Dispersed System Product Design \u003c\/b\u003e\u003cb\u003e298\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 298\u003c\/p\u003e \u003cp\u003e15.2 Formulation Design 298\u003c\/p\u003e \u003cp\u003e15.3 Process Design 322\u003c\/p\u003e \u003cp\u003e15.4 Container Closure System Design 325\u003c\/p\u003e \u003cp\u003e15.5 Risk Management 325\u003c\/p\u003e \u003cp\u003e15.6 Attribute Tests 326\u003c\/p\u003e \u003cp\u003e15.7 New Drug Application Stability Assessment 327\u003c\/p\u003e \u003cp\u003eReferences 328\u003c\/p\u003e \u003cp\u003eGlossary 330\u003c\/p\u003e \u003cp\u003eAppendices 331\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Aerosol Product Design \u003c\/b\u003e\u003cb\u003e336\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 336\u003c\/p\u003e \u003cp\u003e16.2 Inhalation Formulation Design 338\u003c\/p\u003e \u003cp\u003e16.3 Nasal, Buccal, Lingual, and Sublingual Aerosol Formulation Design 351\u003c\/p\u003e \u003cp\u003e16.4 Container Closure System Design 354\u003c\/p\u003e \u003cp\u003e16.5 Risk Management 356\u003c\/p\u003e \u003cp\u003e16.6 Attribute Tests 356\u003c\/p\u003e \u003cp\u003e16.7 New Drug Application Stability Assessment 359\u003c\/p\u003e \u003cp\u003eReferences 363\u003c\/p\u003e \u003cp\u003eGlossary 366\u003c\/p\u003e \u003cp\u003e16.A Appendix 367\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Sterile Injectable Product Design \u003c\/b\u003e\u003cb\u003e369\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 369\u003c\/p\u003e \u003cp\u003e17.2 Formulation Design 370\u003c\/p\u003e \u003cp\u003e17.3 Process Design 393\u003c\/p\u003e \u003cp\u003e17.4 Container Closure System Design 404\u003c\/p\u003e \u003cp\u003e17.5 Risk Management 407\u003c\/p\u003e \u003cp\u003e17.6 Attribute Tests 407\u003c\/p\u003e \u003cp\u003e17.7 New Drug Application Stability Assessment 408\u003c\/p\u003e \u003cp\u003eReferences 409\u003c\/p\u003e \u003cp\u003eGlossary 415\u003c\/p\u003e \u003cp\u003e17.A Appendix 416\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Ophthalmic Product Design \u003c\/b\u003e\u003cb\u003e426\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction – Eye Anatomy and Physiology 426\u003c\/p\u003e \u003cp\u003e18.2 Formulation Design 429\u003c\/p\u003e \u003cp\u003e18.3 Process Design 436\u003c\/p\u003e \u003cp\u003e18.4 Container Closure System Design 436\u003c\/p\u003e \u003cp\u003e18.5 Attribute Tests 436\u003c\/p\u003e \u003cp\u003e18.6 New Drug Application Stability Assessment 436\u003c\/p\u003e \u003cp\u003eReferences 436\u003c\/p\u003e \u003cp\u003eGlossary 438\u003c\/p\u003e \u003cp\u003e18.A Appendix 438\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Transdermal Product Design \u003c\/b\u003e\u003cb\u003e442\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction – Skin Anatomy and Physiology 442\u003c\/p\u003e \u003cp\u003e19.2 Formulation Design 444\u003c\/p\u003e \u003cp\u003e19.3 Conclusions 457\u003c\/p\u003e \u003cp\u003eReferences 457\u003c\/p\u003e \u003cp\u003eGlossary 459\u003c\/p\u003e \u003cp\u003e19.A Appendix 459\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Oral Modified-Release Product Design \u003c\/b\u003e\u003cb\u003e462\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 462\u003c\/p\u003e \u003cp\u003e20.2 FDA and U.S.P. Nomenclature 462\u003c\/p\u003e \u003cp\u003e20.3 Modified-Release Mechanisms 464\u003c\/p\u003e \u003cp\u003e20.4 \u003ci\u003eIn Vitro–In Vivo \u003c\/i\u003eCorrelations (IVIVC) 465\u003c\/p\u003e \u003cp\u003e20.5 Coatings 466\u003c\/p\u003e \u003cp\u003e20.6 Matrix Systems 467\u003c\/p\u003e \u003cp\u003e20.7 Gastroretentive Devices 470\u003c\/p\u003e \u003cp\u003e20.8 Osmotic-Controlled Release Systems 470\u003c\/p\u003e \u003cp\u003e20.9 Conclusions 471\u003c\/p\u003e \u003cp\u003eReferences 471\u003c\/p\u003e \u003cp\u003eGlossary 472\u003c\/p\u003e \u003cp\u003e20.A Appendix 473\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Regulatory Science \u003c\/b\u003e\u003cb\u003e475\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Regulatory Practices and Guidelines \u003c\/b\u003e\u003cb\u003e477\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e21.1 Worldwide Regulatory Agencies 477\u003c\/p\u003e \u003cp\u003e21.2 Good Manufacturing Practice (GMP) 484\u003c\/p\u003e \u003cp\u003e21.3 FDA Inspection and Regulatory Actions (FDA 2020b, 2020d) 503\u003c\/p\u003e \u003cp\u003eReferences 510\u003c\/p\u003e \u003cp\u003eGlossary 511\u003c\/p\u003e \u003cp\u003e21.A Appendix 519\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Regulations for Compounding Pharmacies \u003c\/b\u003e\u003cb\u003e525\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e22.1 Introduction 525\u003c\/p\u003e \u003cp\u003e22.2 Sections 503A and 503B and Their Differences (FDA 2018a) 526\u003c\/p\u003e \u003cp\u003e22.3 Compounding Guidelines 526\u003c\/p\u003e \u003cp\u003e22.4 Good Compounding Practices (FDA 2007; Skoloff 2009; U.S.P \u0026lt;795\u0026gt; 2020: U.S.P \u0026lt;797\u0026gt; 2020); U.S.P. \u0026lt;1191\u0026gt; 2018; USP29 2006; USP29NF24 2006; OSBP 2017; NDBOPH 2020; NV 2020a; OR 2020; CPE 2017; OK 2020; KY 2016a; WA 2020a; FDA 2020a, 2020b) 527\u003c\/p\u003e \u003cp\u003e22.5 Compounding Sterile Preparations (U.S.P. \u0026lt;797\u0026gt; 2020; WA 2020b; CT 2020; OR 2020; NV 2020b; OK 2020; KY 2016b; NYBOP (n.d.); ASPH 2003, 2020; TU n.d.) 532\u003c\/p\u003e \u003cp\u003e22.6 Stability Criteria and Beyond-Use Dating of Compounded Non-Sterile Preparations (U.S.P. \u0026lt;797\u0026gt; 2020; WA 2020b; CT 2020; OR 2020; NV 2020b; OK 2020; KY 2016b; NYBOP (n.d.); ASPH 2003, 2020; TU n.d.) 536\u003c\/p\u003e \u003cp\u003e22.7 Verification (U.S.P. \u0026lt;795\u0026gt; 2020; U.S.P. \u0026lt;797\u0026gt; 2020; WA 2020a, 2020b) 537\u003c\/p\u003e \u003cp\u003e22.8 Patient Counseling (U.S.P. \u0026lt;795\u0026gt; 2020; U.S.P. \u0026lt;797\u0026gt; 2020; WA 2020a, 2020b) 537\u003c\/p\u003e \u003cp\u003e22.9 Patient Monitoring and Adverse Events Reporting (U.S.P. \u0026lt;797\u0026gt; 2020; WA 2020b) 537\u003c\/p\u003e \u003cp\u003e22.10 Pharmacy Compounding Accreditation 537\u003c\/p\u003e \u003cp\u003e22.11 Compounding: Inspections, Recalls, and Other Actions (FDA 2018b; FDA 2018c) 538\u003c\/p\u003e \u003cp\u003eReferences 538\u003c\/p\u003e \u003cp\u003eGlossary 540\u003c\/p\u003e \u003cp\u003e22.A Appendix 541\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 IND and NDA Phase-Appropriate New Drug Development Process \u003c\/b\u003e\u003cb\u003e554\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e23.1 Introduction 554\u003c\/p\u003e \u003cp\u003e23.2 Preclinical Development Overview (FDA 1998) 555\u003c\/p\u003e \u003cp\u003e23.3 Phase-Appropriate Clinical Trials Overview (FDA 1998) 556\u003c\/p\u003e \u003cp\u003e23.4 Investigational New Drugs 558\u003c\/p\u003e \u003cp\u003e23.5 Good Laboratory Practice for Nonclinical Laboratories Studies [21CFR58] (FDA 2020c) 564\u003c\/p\u003e \u003cp\u003e23.6 CGMP for Phase 1 Investigational Drugs – Guidance for Industry (FDA 2008) 566\u003c\/p\u003e \u003cp\u003e23.7 Good Clinical Practice [E6(R2)] Guidance for Industry (FDA 2016, 2018, 2019a) 568\u003c\/p\u003e \u003cp\u003e23.8 NDA Review Process (FDA 1998) 570\u003c\/p\u003e \u003cp\u003eReferences 574\u003c\/p\u003e \u003cp\u003eGlossary 575\u003c\/p\u003e \u003cp\u003e23.A Appendix 576\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 Biological, Biosimilar, Generic, and OTC Products \u003c\/b\u003e\u003cb\u003e584\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24.1 Biologicals (FDA 2015a, 2015b, 2016b 2018a, 2018b, 2019a, 2019b, 2019c, 2020a; EMA 2019) 584\u003c\/p\u003e \u003cp\u003e24.2 Biosimilars (EMA n.d.-a, n.d.-b; FDA n.d.-a, n.d.-b; Christl n.d.; FDA n.d.-c; Lim n.d., 2013; FDA 2017a, 2017b, 2017c,\u003c\/p\u003e \u003cp\u003e2018c, 2020b, 2020c; EMA 2019) 586\u003c\/p\u003e \u003cp\u003e24.3 Generic Drugs (FDA 1998a, 2014b, 2017f, 2017g, 2018e, 2018g, 2019d) 588\u003c\/p\u003e \u003cp\u003e24.4 Over-the-Counter Drugs (FDA 1998b, 2016a, 2018g, 2019f, 2020e, 2020f, 2020g) 593\u003c\/p\u003e \u003cp\u003eReferences 598\u003c\/p\u003e \u003cp\u003eGlossary 600\u003c\/p\u003e \u003cp\u003e24.A Appendix 602\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 Accelerated New Drug Approval and Expedited Access of New Therapies \u003c\/b\u003e\u003cb\u003e605\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e25.1 Introduction 605\u003c\/p\u003e \u003cp\u003e25.2 Expedited Review and Approval of New Therapies (HIV n.d.; IOM 1991; FDA 2009a, 2010a, 2011b, 2014) 605\u003c\/p\u003e \u003cp\u003e25.3 Expanded Access to New Therapies (HIV n.d.; FDA 2009a) 607\u003c\/p\u003e \u003cp\u003e25.4 Orphan Drugs (EMA n.d.-a, n.d.-b; WebMD n.d.; FDA 1998a, 2005a, 2018, 2018b, 2020c; IOM 2010) 608\u003c\/p\u003e \u003cp\u003e25.5 Pediatric Drugs (FDA 1998b, 2005b) 610\u003c\/p\u003e \u003cp\u003e25.6 Pediatric Drug Development and the Orphan Drug Act Incentives (FDA 2010c) 612\u003c\/p\u003e \u003cp\u003e25.7 Common EMEA\/FDA Application for Orphan Medicinal Product Designation (EMA n.d.-a, n.d.-b;\u003c\/p\u003e \u003cp\u003eFDA 2009b; FDA 2018) 612\u003c\/p\u003e \u003cp\u003eReferences 613\u003c\/p\u003e \u003cp\u003eGlossary 614\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 Post–Drug Approval Activities \u003c\/b\u003e\u003cb\u003e617\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e26.1 Postmarket Requirements and Commitments (FDA 2016b, 2018f, 2020a, 2020e) 617\u003c\/p\u003e \u003cp\u003e26.2 Postapproval Manufacturing Changes (FDA 2018d, 2020b) 618\u003c\/p\u003e \u003cp\u003e26.3 Clinical Phase 4 Studies: Postmarketing Surveillance and Risk Assessment (FDA 2018d, 2019b) 619\u003c\/p\u003e \u003cp\u003e26.4 Prescription Drug Advertising and Promotional Labeling Direct to Consumers (FDA 1998c) 622\u003c\/p\u003e \u003cp\u003eReferences 623\u003c\/p\u003e \u003cp\u003eGlossary 624\u003c\/p\u003e \u003cp\u003e26.A Appendix 626\u003c\/p\u003e \u003cp\u003e\u003cb\u003e27 Drug Master Files, EU Dossiers, and API GMP Guidance \u003c\/b\u003e\u003cb\u003e627\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e27.1 Drug Master Files (FDA 2001, 2011a, 2011b, 2011c, 2011d, 2011e) 627\u003c\/p\u003e \u003cp\u003e27.2 European Marketing Authorization Dossiers 633\u003c\/p\u003e \u003cp\u003e27.3 Good Manufactruing Practice (GMP) Guidance for Active Pharmaceutical Ingredients (Q7) (FDA 2016) 636\u003c\/p\u003e \u003cp\u003eReferences 641\u003c\/p\u003e \u003cp\u003eGlossary 643\u003c\/p\u003e \u003cp\u003e\u003cb\u003e28 Commissioning and Qualification \u003c\/b\u003e\u003cb\u003e646\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e28.1 Regulatory Requirements (Health Canada 2009; EU 2015; FDA 2017, 2018a, 2020) 646\u003c\/p\u003e \u003cp\u003e28.2 Preliminary C\u0026amp;Q Activities 647\u003c\/p\u003e \u003cp\u003e28.3 Commissioning 649\u003c\/p\u003e \u003cp\u003e28.4 Qualification and Validation 651\u003c\/p\u003e \u003cp\u003e28.5 Qualification Protocols (ISPE 2001; Health Canada 2009; PIC\/S 2018) 653\u003c\/p\u003e \u003cp\u003e28.6 Process Validation (FDA 2014, 2019; PIC\/S 2018) 657\u003c\/p\u003e \u003cp\u003e28.7 Cleaning Validation (Health Canada 2008; FDA 2014, 2017; PIC\/S 2018) 659\u003c\/p\u003e \u003cp\u003e28.8 Computer Systems Validation (ISPE 2001; EU 2011) 660\u003c\/p\u003e \u003cp\u003e28.9 Change Control (EU 2015; PIC\/S 2018) 660\u003c\/p\u003e \u003cp\u003e28.10 Revalidation (CDRH 1995; EU 2015; FDA 2015; PIC\/S 2018) 661\u003c\/p\u003e \u003cp\u003eReferences 661\u003c\/p\u003e \u003cp\u003eGlossary 663\u003c\/p\u003e \u003cp\u003e\u003cb\u003e29 Quality Systems and Controls \u003c\/b\u003e\u003cb\u003e666\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e29.1 Pharmaceutical Quality System (FDA 2019a) 666\u003c\/p\u003e \u003cp\u003e29.2 Quality Systems Approach to CGMP Regulations 669\u003c\/p\u003e \u003cp\u003e29.3 Inspection of Pharmaceutical Quality Control Laboratories (FDA 2014) 672\u003c\/p\u003e \u003cp\u003e29.4 Pharmacopeias (U.S.P. 2014) 673\u003c\/p\u003e \u003cp\u003e29.5 Analytical Instrument Qualification (U.S.P. \u0026lt;1058\u0026gt; 2019a; FDA 2010) 676\u003c\/p\u003e \u003cp\u003e29.6 Validation of Analytical Procedures (U.S.P. \u0026lt;1225\u0026gt; 2019b; FDA 2000, 2015, 2019b) 679\u003c\/p\u003e \u003cp\u003e29.7 Stability Testing of New Drug Substances and Products (U.S.P. \u0026lt;1150\u0026gt; 2006; ICH 1996; FDA 2018b, 2018c, 2018d) 680\u003c\/p\u003e \u003cp\u003e29.8 Electronic Records; Electronic Signatures (Part 11) (FDA 2019) 682\u003c\/p\u003e \u003cp\u003eReferences 684\u003c\/p\u003e \u003cp\u003eGlossary 686\u003c\/p\u003e \u003cp\u003e29.A Appendix 690\u003c\/p\u003e \u003cp\u003e\u003cb\u003e30 Safety, Toxicology, and Pharmacogenomics \u003c\/b\u003e\u003cb\u003e696\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e30.1 Nonclinical Safety Studies (ICH 2009; FDA 2010) 696\u003c\/p\u003e \u003cp\u003e30.2 Safety Pharmacology Studies (ICH 2000) 697\u003c\/p\u003e \u003cp\u003e30.3 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals – (FDA 1997; EMA 2011a) 700\u003c\/p\u003e \u003cp\u003e30.4 Carcinogenicity Studies of Pharmaceuticals (ICH 1995) 701\u003c\/p\u003e \u003cp\u003e30.5 Genotoxicity Testing (ICH 1998, 2008) 702\u003c\/p\u003e \u003cp\u003e30.6 Immunotoxicity Studies (ICH 2005b) 704\u003c\/p\u003e \u003cp\u003e30.7 Safety Reporting Requirements 705\u003c\/p\u003e \u003cp\u003e30.8 Pharmacogenomics (NIGMS 2005; ICH 2005b; ORNL 2010) 706\u003c\/p\u003e \u003cp\u003e30.9 Pharmacovigilance (EMA 2011b, 2015, 2021; Eudro n.d.; FDA 2005c, 2005d) 709\u003c\/p\u003e \u003cp\u003e30.10 FDA’s Predictive Toxicology Roadmap (FDA 2017, 2020) 711\u003c\/p\u003e \u003cp\u003eReferences 711\u003c\/p\u003e \u003cp\u003eGlossary 713\u003c\/p\u003e \u003cp\u003eAppendix 716\u003c\/p\u003e \u003cp\u003e\u003cb\u003e31 Regulatory Science Initiatives for Advancing Public Health \u003c\/b\u003e\u003cb\u003e719\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e31.1 Introduction 719\u003c\/p\u003e \u003cp\u003e31.2 Advancing Regulatory Science for Public Health – A Framework for FDA’s Regulatory Science Initiatives (FDA 2010) 719\u003c\/p\u003e \u003cp\u003e31.3 Advancing Regulatory Science at FDA – A Strategic Plan (FDA 2018b, 2018c, 2018d, 2018e, 2018f, 2018g, 2018h, 2018i, 2018j, 2018k, 2018l) 719\u003c\/p\u003e \u003cp\u003e31.4 A Collaborative Implementation Framework (FDA 2010, 2011, 2018n) 723\u003c\/p\u003e \u003cp\u003eReferences 724\u003c\/p\u003e \u003cp\u003e\u003cb\u003e32 Medical Devices \u003c\/b\u003e\u003cb\u003e726\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e32.1 Introduction (FDA 2018a, 2019a, 2020a) 726\u003c\/p\u003e \u003cp\u003e32.2 Device Determination Steps (FDA 2019a, 2020a) 726\u003c\/p\u003e \u003cp\u003e32.3 Classification and Regulatory Requirements (FDA 2018b, 2020b) 727\u003c\/p\u003e \u003cp\u003e32.4 Current Good Manufacturing Practices (CGMPs) and Quality System Regulation (QSR Regulation) Requirements 729\u003c\/p\u003e \u003cp\u003e32.5 Medical Device Complaint Reporting and Recalls (FDA 2019h, 2019i) 731\u003c\/p\u003e \u003cp\u003eReferences 731\u003c\/p\u003e \u003cp\u003eGlossary 732\u003c\/p\u003e \u003cp\u003e\u003cb\u003e33 Combination Products \u003c\/b\u003e\u003cb\u003e735\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e33.1 Introduction (FDA 2018, 2019e, 2020) 735\u003c\/p\u003e \u003cp\u003e33.2 Product Jurisdiction\/Assignment of Combination and Non-Combination Products (FDA 2019a, 2020) 736\u003c\/p\u003e \u003cp\u003e33.3 Premarket and Marketing Applications (21 CFR Parts 312 and 812) (FDA 2019b, 2019c, 2020) 736\u003c\/p\u003e \u003cp\u003e33.4 Current Good Manufacturing Practice – Subpart A (21CFR4) (FDA 2019d) 737\u003c\/p\u003e \u003cp\u003e33.5 Postmarkeing Safety Reporting for Combination Products [21CFR4\/Part 4 Regulation of Combination Products\/Subpart B] (FDA 2019d) 737\u003c\/p\u003e \u003cp\u003eReferences 738\u003c\/p\u003e \u003cp\u003e33.A Appendix 739\u003c\/p\u003e \u003cp\u003e\u003cb\u003e34 Dietary Supplements \u003c\/b\u003e\u003cb\u003e740\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e34.1 Introduction (FDA 2017a, 2019a, 2019b) 740\u003c\/p\u003e \u003cp\u003e34.2 Dietary Ingredients (FDA 2019a, 2019b, 2019c) 740\u003c\/p\u003e \u003cp\u003e34.3 Dietary Supplement Ingredient Advisory List (FDA 2019d) 741\u003c\/p\u003e \u003cp\u003e34.4 DS Labeling: Claims Types and Requirements (FDA 2017b, 2018, 2019e) 741\u003c\/p\u003e \u003cp\u003e34.5 Current Good Manufacturing Practice in Manufacturing, Packaging, Lableing, or Holding Operations for Dietary Supplements (21 CFR Part 111) (FDA 2019f) 741\u003c\/p\u003e \u003cp\u003e34.6 FDA Inspection and Regulatory Actions (see – 21.3 FDA Inspection and Regulatory Actions – see Chapter 21 for details) 745\u003c\/p\u003e \u003cp\u003eReferences 745\u003c\/p\u003e \u003cp\u003eGlossary 745\u003c\/p\u003e \u003cp\u003e34.A Appendix 746\u003c\/p\u003e \u003cp\u003e\u003cb\u003e35 Animal Drugs and Devices \u003c\/b\u003e\u003cb\u003e751\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e35.1 FDA Center For Veterinary Medicine (CVM) (FDA 2019a) 751\u003c\/p\u003e \u003cp\u003e35.2 Animal Drug Availability Act of 1996 (FDA 2019b) 751\u003c\/p\u003e \u003cp\u003e35.3 Development and Approval Process (FDA 2017, 2020a) 752\u003c\/p\u003e \u003cp\u003e35.4 CGMP and Others Compliance Requirements 756\u003c\/p\u003e \u003cp\u003e35.5 Animal Drug Manufacturing Inspection – Pre-Approval (FDA 2006) 756\u003c\/p\u003e \u003cp\u003e35.6 PostMarketing Survellance (FDA 2017, 2019d, 2020a) 756\u003c\/p\u003e \u003cp\u003eReferences 757\u003c\/p\u003e \u003cp\u003eIndex 759\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":53186831384919,"sku":"9781119574699","price":999.99,"currency_code":"GBP","in_stock":false}],"url":"https:\/\/bookcurl.com\/products\/integrated-pharmaceutics-applied-preformulation-product-design-and-regulatory-science-2nd-edition-9781119574699","provider":"Book Curl","version":"1.0","type":"link"}