{"product_id":"integrated-pharmaceutics-isbn-9781119574699","title":"Integrated Pharmaceutics","description":"\u003cp\u003e\u003cb\u003eThis work is an examination of all aspects of the science in developing effective dosage form for drug delivery\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003ePharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug's performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. \u003c\/p\u003e\u003cp\u003eIntegrated Pharmaceutics provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. \u003c\/p\u003e\u003cp\u003eReaders of the second edition of \u003ci\u003eIntegrated Pharmaceutics \u003c\/i\u003ewill also find: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eA glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter\u003c\/li\u003e \u003cli\u003eEarlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products”\u003c\/li\u003e \u003cli\u003eSupplementary instructor guide with questions and solutions available online for registered professors\u003c\/li\u003e \u003cli\u003eUpdated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003ci\u003eIntegrated Pharmaceutics \u003c\/i\u003eis a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide. \u003c\/p\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  \u003cp\u003e\u003cb\u003eAntoine Al-Achi, PhD,\u003c\/b\u003e is a Professor of Pharmaceutical Sciences at the College of Pharmacy \u0026amp; Health Sciences at Campbell University in North Carolina. He is also a former track head of the Industrial Pharmacy graduate major and former Head of the Formulation Development Division of Campbell’s Pharmaceutical Sciences Institute. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eMali Ram Gupta, PhD,\u003c\/b\u003e is an Associate Professor Emeritus of Pharmaceutical Sciences and Director of Pharmaceutical Education \u0026amp; Research (PERC) in the College of Pharmacy \u0026amp; Health Sciences Campbell University. Prior to joining Campbell in 2005, he spent over 25 years managing QA\/QC departments of various pharma, cosmetic, and diagnostic companies. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eWilliam Craig Stagner, PhD,\u003c\/b\u003e is a Professor Emeritus of Pharmaceutical Sciences at the College of Pharmacy \u0026amp; Health Sciences Campbell University. In his time at Glaxo Research Institute (1987-95), he established the Pharmaceutics Department.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eThis work is an examination of all aspects of the science in developing effective dosage form for drug delivery\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003ePharmaceutics refers to the subfield of pharmaceutical sciences that develops drug delivery products or devices to optimize the drug’s performance once administered. This multidisciplinary field draws on physical chemistry, organic chemistry, and biophysics to generate and refine these crucial elements of medical care. Moreover, incorporating such disparate dimensions of drug product design as material properties and legal regulation bridges the gap between effective chemicals and viable medical treatments. \u003c\/p\u003e\u003cp\u003e\u003ci\u003eIntegrated Pharmaceutics\u003c\/i\u003e provides a comprehensive introduction to the creation and manufacture of effective dosage forms for drug delivery. It presents its subject following the principles of physical pharmacy, product design, and drug regulations. This tripartite structure allows readers to move from theory to practice, beginning from a firm foundation of physical pharmacy principles, including drug solubility and stability estimation, rheology, and interfacial properties. From there, it proceeds to discussions of drug product design and of harmonizing pharmaceutical design with the regulatory regimens and technological standards of the United States, European Union, and Japan. \u003c\/p\u003e\u003cp\u003eReaders of the second edition of \u003ci\u003eIntegrated Pharmaceutics\u003c\/i\u003e will also find: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eA glossary defining key terms, extensive informative appendices, and a list of references leading to the primary literature in the field for each chapter\u003c\/li\u003e \u003cli\u003eEarlier chapters are expanded, with additional new chapters including one entitled “Biotechnology Products”\u003c\/li\u003e \u003cli\u003eSupplementary instructor guide with questions and solutions available online for registered professors\u003c\/li\u003e \u003cli\u003eUpdated regulatory guidelines including quality by design, design space analysis, process analytical technology, polymorphism characterization, blend sample uniformity, and stability protocols\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eIntegrated Pharmaceutics\u003c\/i\u003e is a useful textbook for graduate students in pharmaceutical sciences, drug formulation and design, and biomedical engineering. In addition, professionals in the pharmaceutical industry, including regulatory bodies, will find it a helpful reference guide.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989437202661,"sku":"NP9781119574699","price":215.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781119574699.jpg?v=1761784096","url":"https:\/\/k12savings.com\/products\/integrated-pharmaceutics-isbn-9781119574699","provider":"K12savings","version":"1.0","type":"link"}