Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing

Pharmaceutical Sciences Encyclopedia: Drug Discovery, Development, and Manufacturing

Online ISBN: 9780470571224

DOI: 10.1002/9780470571224

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  1. Drug Discovery
    1. 1 Introduction: Drug Discovery in the 21st Century
    2. 2 Natural Products
    3. 3 Cancer Cell Proteomics using Molecular Aptamers
    4. 4 Molecular Similarity Methods and QSAR Models As Tools for Virtual Screening
    5. 5 Systems Biology: Applications in Drug Discovery
    6. 6 High-Throughput Flow Cytometry
    7. 7 Combining NMR Spectral Information with Associated Structural Features to form Computationally Nonintensive, Rugged, and Objective Models of Biological Activity
    8. 8 Using Microsoft Excel® as a Laboratory Data Management Tool
    9. 9 Age of Regulation
    10. 10 Simultaneous Screening of Multiple Cell Lines Using the CellCard System
    11. 11 Protein X-Ray Crystallography in Drug Discovery
    12. 12 Biological and Chemistry Assays Available During Drug Discovery And Developability Assessment
    13. 13 Strategies and Methods in Monitoring and Targeting Protein–Protein Interactions
    14. 14 High-Throughput Screening: Evolution of Technology and Methods
    15. 15 Metal-Enhanced Fluorescence: Application to High-Throughput Screening and Drug Discovery
    16. 16 Methods for the Design and Analysis of Replicate-Experiment Studies to Establish Assay Reproducibility and the Equivalence of Two Potency Assays
    17. 17 Coupled Luminescent Methods in Drug Discovery: 3-min Assays for Cytotoxicity and Phosphatase Activity
    18. 18 Design and Pharmaceutical Applications of Prodrugs
    19. 19 GABA and Glutamate Receptor Ligands and their Therapeutic Potential in CNS Disorders
    20. 20 Cardiac Sarcolemmal ATP-Sensitive Potassium Channel Antagonists: Novel Ischemia-Selective Antiarrhythmic Agents
    21. 21 Factors Influencing the Efficacy of Mediator-Specific Anti-Inflammatory, Glucocorticoid, and Anticoagulant Therapies for Sepsis
    22. 22 Combinatorial Chemistry in the Drug Discovery Process
    23. 23 Herbal Medicines and Animal Models of Gastrointestinal Diseases
    24. 24 Endocrine and Metabolic Agents
    25. 25 Respiratory Viruses
    26. 26 Strategies in the Design of Antiviral Drugs
    27. 27 Protein Kinase Inhibitors in Drug Discovery
    28. 28 RNA-Based Therapies
    29. 29 Novel Imaging Agents for Molecular MR Imaging of Cancer
    30. 30 Targets and Approaches for Cancer Drug Discovery
  2. Development of Therapeutic Agents Handbook
    1. 416 Current Needs for New Therapeutic Agents and Discovery Strategies—A Systems Pharmacology Approach
    2. 419 Target Selection in Drug Discovery
    3. 420 New Drug Applications
    4. 421 From Concept to the Clinics: Development of Cancer Therapeutics
    5. 422 Development of Countermeasures for Bioterrorism in the United States
    6. 423 Development and Application of Conformation-Selective Integrin Antibodies
    7. 424 Pain Management Market Overview
    8. 425 Antiviral Market Overview
    9. 426 High-Throughput Screening for Small-Molecule Drug Discovery
    10. 427 Mass Spectrometry
    11. 428 Molecular Screening for Therapeutic Agents
    12. 429 Accelerator Mass Spectrometry and Positron Emission Tomography in Human Microdosing
    13. 430 Development of Antimicrobial Peptides as Therapeutic Agents
    14. 431 Antibodies for Human Diseases
    15. 432 Combinatorial Compounds and Drug Discovery
    16. 433 Locoregional Chemoradiotherapy of Cancer Using Hydrogel
    17. 434 RNAi-Mediated Therapeutics
    18. 435 Crystallography
    19. 436 PEGylation
    20. 437 Gold Standard Animal Models
    21. 438 Discovery of Vaccine Adjuvants
    22. 439 Oral Delivery of Macromolecules for the Development of Therapeutic Agents
    23. 440 Aerosol Drug Delivery to the Lungs
    24. 441 Resistance to Antiplatelet Therapy
    25. 442 Antibiotic Development
    26. 443 Antimicrobial Resistance in Biofilms: A Sticky Situation
    27. 444 Drotrecogin Alfa Activated (Recombinant Human Activated Protein C, Xigris)
    28. 445 Anti-Inflammatory Therapeutics
    29. 446 Anti-Inflammatory/Analgesics: An In-Depth Look at p38 MAP Kinases
    30. 447 Cardiovascular Disease: In-Depth Look
    31. 448 Ezetimibe and Cholesterol Absorption
    32. 449 Cardiology—In-Depth Look: Kinases as Therapeutic Targets in the Heart
    33. 450 Statins in the Reduction of Cardiovascular Events
    34. 451 Cardiology—In-Depth Look: Advances in Antiplatelet Therapy
    35. 452 Gastrointestinal Disorders: A Focus on Acid-Suppressive Agents
    36. 453 Pharmacology of Vasopressin and the Renin–Angiotensin–Aldosterone System
    37. 454 New Drugs and Nutraceuticals in the Treatment of Osteoarthritis
    38. 455 Development of Anticytokine Agents for Rheumatoid Arthritis
    39. 456 Overview of CNS Neuropharmaceuticals
    40. 457 Thinking Outside the Box in Alzheimer Disease Treatment
    41. 458 Neurotrophic Factors as Novel Therapeutic Targets
    42. 459 Oncology
    43. 460 Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
    44. 461 Aromatase Inhibitors for Breast Cancer
    45. 462 Evolution of Selective Estrogen and Androgen Receptor Modulators: Status of Current Therapy and New Drug Development
    46. 463 In-Depth Look: Anti-TNF-α Therapies
    47. 464 Development of Therapeutic Agents: The Maternal–Fetal Perspective
    48. 465 History of Antipsychotic Drug Development
    49. 466 Radiopharmaceuticals and Medical Imaging: Development of Radioimmumoconjugates for Radioimmunoimaging and Radioimmunotherapy of Malignant Diseases
    50. 467 Therapeutic Drug Development for Kidney Diseases
    51. Targeting Chemokines and Angiogenesis in Rheumatoid Arthritis
    52. 469 Development of Therapeutic Agents: Methods and Approaches in the Development of Vaccines Against Protozoan Parasites
    53. 470 Toxicology
    54. 471 Development of Phosphodiesterase 4 Inhibitors for Allergic and Nonallergic Inflammatory Diseases of the Airways
  3. Preclinical Development: ADME and Biopharmaceutical Properties
    1. 31 Modeling and Informatics in Drug Design
    2. 32 Computer Techniques: Identifying Similarities Between Small Molecules
    3. 33 Protein–Protein Interactions
    4. 34 Method Development for Preclinical Bioanalytical Support
    5. 35 Analytical Chemistry Methods: Developments and Validation
    6. 36 Chemical and Physical Characterizations of Potential New Chemical Entity
    7. 37 Permeability Assessment
    8. 38 How and Where are Drugs Absorbed?
    9. 39 Absorption of Drugs after Oral Administration
    10. 40 Distribution: Movement of Drugs through the Body
    11. 41 The Blood – Brain Barrier and its Effect on Absorption and Distribution
    12. 42 Transporter Interactions in the ADME Pathway of Drugs
    13. 43 Accumulation of Drugs in Tissues
    14. 44 Salt and Cocrystal Form Selection
    15. 45 Dissolution
    16. 46 Stability: Physical and Chemical
    17. 47 Dosage Formulation
    18. 48 Cytochrome P450 Enzymes
    19. 49 Metabolism Kinetics
    20. 50 Drug Clearance
    21. 51 In Vitro Metabolism in Preclinical Drug Development
    22. 52 Utilization of In Vitro Cytochrome P450 Inhibition Data for Projecting Clinical Drug–Drug Interactions
    23. 53 In Vivo Metabolism in Preclinical Drug Development
    24. 54 In Vitro Evaluation of Metabolic Drug–Drug Interactions: Scientific Concepts and Practical Considerations
    25. 55 Mechanisms and Consequences of Drug–Drug Interactions
    26. 56 Species Comparison of Metabolism in Microsomes and Hepatocytes
    27. 57 Metabolite Profiling and Structural Identification
    28. 58 Linkage Between Toxicology of Drugs and Metabolism
    29. 59 Allometric Scaling
    30. 60 Interrelationship between Pharmacokinetics and Metabolism
    31. 61 Experimental Design Considerations in Pharmacokinetic Studies
    32. 62 Bioavailability and Bioequivalence Studies
    33. 63 Mass Balance Studies
    34. 64 Pharmacodynamics
    35. 65 Physiologically Based Pharmacokinetic Modeling
    36. 66 Mathematical Modeling as a New Approach for Improving the Efficacy/Toxicity Profile of Drugs: The Thrombocytopenia Case Study
    37. 67 Regulatory Requirements for INDs/FIH (First in Human) Studies
    38. 68 Data Analysis
  4. Preclinical Development: Toxicology
    1. 69 Preclinical Drug Development Planning
    2. 70 Use of Project Teams in Preclinical Development
    3. 71 Relationship between Animal Models and Clinical Research: Using Mucositis As A Practical Example
    4. 72 Bacterial Mutation Assay
    5. In Vitro Mammalian Cell Mutation Assays
    6. 74 In Vitro Mammalian Cytogenetic Tests
    7. 75 In vivo Genotoxicity Assays
    8. 76 Repeat Dose Toxicity Studies
    9. 77 Irritation and Local Tissue Tolerance Studies in Pharmacetical Safety Assessment
    10. 78 Safety Assessment Studies: Immunotoxicity
    11. 79 Immunotoxicity Testing: ICH Guideline S8 and Related Aspects
    12. 80 Reproductive and Developmental Toxicology
    13. 81 Carcinogenicity Studies
    14. 82 Toxicokinetics: An Integral Component of Preclinical Toxicity Studies
    15. 83 In Vitro Toxicokinetics and Dynamics: Modeling and Interpretation of Toxicity Data
    16. 84 Toxicologic Pathology
    17. 85 Secondary Pharmacodynamic Studies and In vitro Pharmacological Profiling
    18. 86 Current Practices in Safety Pharmacology
    19. 87 Safety Assessment of Biotechnology-derived Therapeutics
    20. 88 Preclinical Development of Protein Pharmaceuticals: An overview
    21. 89 The Pharmacogenomics of Personalized Medicine
    22. 90 Genomics
    23. 91 Proteomics
    24. 92 Toxicogenomics in Preclinical Development
    25. 93 Toxicoproteomics: Preclinical Studies
    26. 94 Regulatory Considerations
    27. 95 Regulatory Issues in Preclinical Safety Studies (U.S. FDA)
    28. 96 Selection and Utilization of CROs for Safety Assessment
    29. 97 Auditing and Inspecting Preclinical Research and Compliance with Good Laboratory Practice (GLP)
    30. 98 Drug Impurities and Degradants and Their Safety Qualification
    31. 99 Bridging Studies in Preclinical Pharmaceutical Safety Assessment
  5. Analysis and Pharmaceutical Quality
    1. 399 Applications of High Performance Ion-Exchange Chromatography in the Pharmaceutical Industry
    2. 400 Automation in Quality
    3. 401 Capillary Electrophoresis of Dendrimer-Related Medical Nanodevices
    4. 402 From Concept to the Clinics: Development of Novel Large Molecule Cancer Therapeutics
    5. 403 Karl Fischer Titration: Determination of Water Content in Pharmaceuticals
    6. 404 EDTA Titrations
    7. 405 Electronic Circular Dichroism Spectroscopy
    8. 406 Good Manufacturing Practices—Steps to Improve Quality
    9. 407 High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis
    10. 408 Microdialysis
    11. 409 Handbook of Analysis and Pharmaceutical Quality: Nano-Methods
    12. 410 Quality by Design for the Pharmaceutical Industry
    13. 411 X-Ray Fluorescence Spectrometry in Medicine
    14. 412 Statistical Tools
    15. 413 Systems-Based Approach to Laboratory Compliance with the Current Good Manufacturing Practice (CGMP) Regulations
    16. 414 Uses of X-Ray Powder Diffraction In the Pharmaceutical Industry
    17. 415 Water Determination By Karl Fischer Titration
    18. 417 Vibrational Circular Dichroism: Ensuring Quality of Pharmaceutical Products
  6. Pharmaceutical Formulation
    1. 418 New Approaches to the Characterization of Drug Candidates by Solid-State NMR
  7. Drug Metabolism: Concepts and Applications
    1. 100 Historical Perspective
    2. 101 Factors Affecting Metabolism
    3. 102 Biotransformations in Drug Metabolism
    4. 103 In Vivo Metabolite Kinetics
    5. 104 Pharmacogenetics and Pharmacogenomics
    6. 105 Introduction to Drug Transporters
    7. 106 Automated Drug Screening for ADMET Properties
    8. 107 Mass Spectrometry
    9. 108 Approaches to Performing Metabolite Elucidation: One Key to Success in Drug Discovery and Development
    10. 109 Structural Modifications of Drug Candidates: How Useful Are They in Improving Metabolic Stability of New Drugs? Part I: Enhancing Metabolic Stability
    11. 110 Structural Modifications of Drug Candidates: How Useful Are They in Improving PK Parameters of New Drugs? Part II: Drug Design Strategies
    12. 111 Minimizing the Potential for Drug Bioactivation of Drug Candidates to Success in Clinical Development
    13. 112 Screening for Reactive Metabolites Using Genotoxicity Arrays and Enzyme/DNA Biocolloids
    14. 113 Enzyme Inhibition
    15. 114 Evaluating and Predicting Human Cytochrome P450 Enzyme Induction
    16. 115 An Introduction to Metabolic Reaction Phenotyping
    17. 116 Nuclear Receptor-Mediated Gene Regulation in Drug Metabolism
    18. 117 Characterization of Cytochrome P450 Mechanism-Based Inhibition
    19. 118 Clinical Drug–Drug Interactions
    20. 119 Pharmaceutical Excipients in Drug–Drug Interaction
    21. 120 The Role of Drug Metabolism in Toxicity
    22. 121 Allergic Reactions to Drugs
    23. 122 Chemical Mechanisms in Toxicology
    24. 123 Mechanisms of Reproductive Toxicity
    25. 124 An Introduction to Toxicogenomics
    26. 125 Role of Bioactivation Reactions in Chemically Induced Nephrotoxicity
    27. 126 Drug Metabolism in Regulatory Guidances, Clinical Trials, and Product Labeling
  8. Drug Safety Evaluation, 2nd Edition
    1. 127 Drug Development Process and Global Pharmaceutical Marketplace
    2. 128 Regulation of Human Pharmaceutical Safety
    3. 129 Prior Art and Its Use in Safety Assessment Process
    4. 130 Screens in Safety and Hazard Assessment
    5. 131 Formulations, Routes, and Dosage Design
    6. 132 Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation
    7. 133 Genotoxicity
    8. 134 Repeat-Dose Toxicity Studies
    9. 135 Immunotoxicology in Drug Development
    10. 136 Nonrodent Animal Studies
    11. 137 Developmental and Reproductive Toxicity Testing
    12. 138 Carcinogenicity Studies
    13. 139 Histopathology in Nonclinical Pharmaceutical Safety Assessment
    14. 140 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment
    15. 141 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation
    16. 142 Safety Pharmacology
    17. 143 Special Concerns for Preclinical Evaluation of Biotechnology Products
    18. 144 Safety Assessment of Inhalant and Dermal Route Drugs
    19. 145 Special-Case Products: Imaging Agents and Oncology Drugs
    20. 146 Occupational Toxicology in Pharmaceutical Industry
    21. 147 Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals
    22. 148 Application of In Vitro Techniques in Drug Safety Assessment
    23. 149 Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond
    24. 150 Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses
    25. 151 Statistics in Pharmaceutical Safety Assessment
    26. 152 Combination Products: Drugs and Devices
    27. 153 Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals
    28. 154 Selected Regulatory and Toxicological Acronyms
    29. 155 Definition of Terms and Lexicon of Clinical Observations in Nonclinical? (Animal) Studies
    30. 156 Notable Regulatory Internet Addresses
    31. 157 Glossary of Terms Used in Clinical Evaluation of Therapeutic Agents
    32. 158 Common Vehicles for Nonclinical Evaluation of Therapeutic Agents
    33. 159 Global Directory of Contract Toxicology Laboratories
  9. Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials
    1. 160 Biopharmaceuticals: Definition and Regulation
    2. 161 Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact
    3. 162 The Principles of ICH S6 and the Case-by-Case Approach
    4. 163 Implementation of ICH S6: EU Perspective
    5. 164 Implementation of ICH S6: Japanese Perspective
    6. 165 Implementation of ICH S6: US Perspective
    7. 166 Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies, Timing, Materials, and Costs
    8. 167 Demonstration of Comparability of a Licensed Product after a Manufacturing Change
    9. 168 Selection of Relevant Species
    10. 169 Tissue Cross-Reactivity Studies for Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species for Toxicity Testing
    11. 170 Physiologic IgG Biodistribution, Transport, and Clearance: Implications for Monoclonal Antibody Products
    12. 171 The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species
    13. 172 Use of Animal Models of Disease in the Preclinical Safety Evaluation of Biopharmaceuticals
    14. 173 Safety Pharmacology: Similarities and Differences between Small Molecules and Novel Biopharmaceuticals
    15. 174 Genetic Toxicology Testing of Biopharmaceuticals
    16. 175 General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals
    17. 176 Reproductive Toxicity Testing for Biopharmaceuticals
    18. 177 Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates
    19. 178 Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals
    20. 179 Immunogenicity of Therapeutic Proteins and the Assessment of Risk
    21. 180 Assessment of Autoimmunity and Hypersensitivity
    22. 181 Current Practices in the Preclinical Safety Assessment of Peptides
    23. 182 Enzyme Replacement Therapies
    24. 183 Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities
    25. 184 Preclinical Safety Evaluation of Biological Oncology Drugs
    26. 185 Preclinical Safety Evaluation of Monoclonal Antibodies
    27. 186 Immunomodulatory Biopharmaceuticals and Risk of Neoplasia
    28. 187 Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold Therapeutics
    29. 188 Preclinical Safety Evaluation of Immunotoxins
    30. 189 Preclinical Safety Evaluation of Blood Products
    31. 190 Preclinical Safety Evaluation of Viral Vaccines
    32. 191 Preclinical Safety Evaluation of Biopharmaceuticals
    33. 192 Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies
    34. 193 Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products (Biologic/Device)
    35. 194 Tissue Engineered Products: Preclinical Development of Neo-Organs
    36. 195 GLP Requirements and Current Practices
    37. 196 Preclinical Safety Study Design Templates and Estimated Costs
    38. 197 Practical Considerations in the Design of Preclinical Safety Assessments for Biopharmaceuticals
    39. 198 Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals
    40. 199 Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals
  10. Clinical Trials
    1. 200 Introduction to Clinical Trials
    2. 201 Regulatory Requirements for Investigational New Drug
    3. 202 Preclinical Assessment of Safety in Human Subjects
    4. 203 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies
    5. 204 History of Clinical Trial Development and the Pharmaceutical Industry
    6. 205 Adaptive Research
    7. 206 Organization and Planning
    8. 207 Process of Data Management
    9. 208 Clinical Trials Data Management
    10. 209 Clinical Trials and the Food and Drug Administration
    11. 210 Phase I Clinical Trials
    12. 211 Phase II Clinical Trials
    13. 212 Designing and Conducting Phase III Studies
    14. 213 Phase IV: Postmarketing Trials
    15. 214 Phase IV and Postmarketing Clinical Trials
    16. 215 Regulatory Approval
    17. New Paradigm for Analyzing Adverse Drug Events
    18. 217 Clinical Trials in Interventional Cardiology: Focus on XIENCE V Drug-Eluting Stent
    19. 218 Clinical Trials Involving Oral Diseases
    20. 219 Dermatology Clinical Trials
    21. 220 Emergency Clinical Trials
    22. 221 Gastroenterology
    23. 222 Gynecology Randomized Control Trials
    24. 223 Special Population Studies (Healthy Patient Studies)
    25. 224 Musculoskeletal Disorders
    26. 225 Oncology
    27. 226 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration
    28. 227 Paediatrics
    29. 228 Clinical Trials in Dementia
    30. 229 Clinical Trials in Urology
    31. 230 Clinical Trials on Cognitive Drugs
    32. 231 Bridging Studies in Pharmaceutical Safety Assessment
    33. 232 Brief History of Clinical Trials on Viral Vaccines
    34. 233 Methods of Randomization
    35. 234 Randomized Controlled Trials
    36. 235 Cross-Over Designs
    37. You have free access to this content
      236 Biomarkers
    38. 237 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis
    39. 238 Review Boards
    40. 239 Size of Clinical Trials
    41. 240 Blinding and Placebo
    42. 241 Pharmacology
    43. 242 Modeling and Simulation in Clinical Drug Development
    44. 243 Monitoring
    45. 244 Inference Following Sequential Clinical Trials
    46. 245 Statistical Methods for Analysis of Clinical Trials
    47. 246 Explanatory and Pragmatic Clinical Trials
    48. 247 Ethics of Clinical Research in Drug Trials
    49. 248 Ethical Issues in Clinical Research
    50. 249 Regulations
    51. 250 Future Challenges in Design and Ethics of Clinical Trials
    52. 251 Proof-of-Principle/Proof-of-Concept Trials in Drug Development
  11. Biomarkers in Drug Development: Practice, Application, and Strategy
    1. 252 Biomarkers Are Not New
    2. 253 Biomarkers: Facing the Challenges at the Crossroads of Research and Health Care
    3. 254 Enabling Go/No Go Decisions
    4. 255 Imaging as a Localized Biomarker: Opportunities and Challenges
    5. 256 Protein Biomarker Discovery Using Mass Spectrometry–Based Proteomics
    6. 257 Quantitative Multiplexed Patterning of Immune-Related Biomarkers
    7. 258 Gene Expression Profiles as Preclinical and Clinical Cancer Biomarkers of Prognosis, Drug Response, and Drug Toxicity
    8. 259 Use of High-Throughput Proteomic Arrays for the Discovery of Disease-Associated Molecules
    9. 260 Characterization and Validation Biomarkers in Drug Development: Regulatory Perspective
    10. 261 Fit-for-Purpose Method Validation and Assays for Biomarker Characterization to Support Drug Development
    11. 262 Molecular Biomarkers from a Diagnostic Perspective
    12. 263 Strategies for the Co-Development of Drugs and Diagnostics: FDA Perspective on Diagnostics Regulation
    13. 264 Importance of Statistics in the Qualification and Application of Biomarkers
    14. 265 Qualification of Safety Biomarkers for Application to Early Drug Development
    15. 266 Development of Serum Calcium and Phosphorus as Clinical Biomarkers for Drug-Induced Systemic Mineralization: Case Study with a MEK Inhibitor
    16. 267 Biomarkers for the Immunogenicity of Therapeutic Proteins and Its Clinical Consequences
    17. 268 New Markers of Kidney Injury
    18. 269 Translational Medicine—a Paradigm Shift in Modern Drug Discovery and Development: The Role of Biomarkers
    19. 270 Clinical Validation and Biomarker Translation
    20. 271 Predicting and Assessing an Inflammatory Disease and Its Complications: Example from Rheumatoid Arthritis
    21. 272 Pharmacokinetic and Pharmacodynamic Biomarker Correlations
    22. 273 Validating In Vitro Toxicity Biomarkers Against Clinical Endpoints
    23. 274 Opportunities and Pitfalls Associated with Early Utilization of Biomarkers: Case Study in Anticoagulant Development
    24. 275 Integrating Molecular Testing into Clinical Applications
    25. 276 Biomarkers for Lysosomal Storage Disorders
    26. 277 Value Chain in the Development of Biomarkers for Disease Targets
    27. 278 Biomarkers in Pharmaceutical Development: The Essential Role of Project Management and Teamwork
    28. 279 Integrating Academic Laboratories Into Pharmaceutical Development
    29. 280 Funding Biomarker Research and Development through the Small Business Innovative Research Program
    30. 281 Novel and Traditional Nonclinical Biomarker Utilization in the Estimation of Pharmaceutical Therapeutic Indices
    31. 282 Anti-Unicorn Principle: Appropriate Biomarkers Don't Need to be Rare or Hard to Find
    32. 283 Biomarker Patent Strategies: Opportunities and Risks
    33. 284 IT Supporting Biomarker-Enabled Drug Development
    34. 285 Redefining Disease and Pharmaceutical Targets Through Molecular Definitions and Personalized Medicine
    35. 286 Ethics of Biomarkers: the Borders of Investigative Research, Informed Consent, and Patient Protection
    36. 287 Pathodynamics: Improving Biomarker Selection by Getting More Information from Changes Over Time
    37. 288 Optimizing the Use of Biomarkers for Drug Development: A Clinician's Perspective
    38. 289 Nanotechnology-Based Biomarker Detection
  12. Pharmaceutical Biotechnology
    1. 290 From Gene to Product: the Advantage of Integrative Biotechnology
    2. 291 Sequencing the Human Genome: Was it Worth It?
    3. 292 Overview: Differentiating Issues in the Development of Macromolecules Compared with Small Molecules
    4. 293 Integrated Development of Glycobiologics: from Discovery to Applications in the Design of Nanoparticular Drug Delivery Systems
    5. 294 R&D Paradigm Shift and Billion-Dollar Biologics
    6. 295 From Defining Bioinformatics and Pharmacogenomics to Developing Information-Based Medicine and Pharmacotyping in Health Care
    7. 296 Toxicogenomics
    8. 297 Preclinical Pharmacokinetics
    9. 298 Strategies for the Cytosolic Delivery of Macromolecules: An Overview
    10. 299 Basic Issues in the Manufacture of Macromolecules
    11. 300 Process Validation for Biopharmaceuticals
    12. 301 Stability Assessment and Formulation Characterization
    13. 302 Protein Posttranslational Modification: A Potential Target in Pharmaceutical Development
    14. 303 Pegylation: Camouflage of Proteins, Cells, and Nanoparticles Against Recognition by the Body's Defense Mechanism
    15. 304 Unexpected Benefits of a Formulation: Case Study with Erythropoetin
    16. 305 Capillary Separation Techniques
    17. 306 Pharmaceutical Bioassay
    18. 307 Analytical Considerations for Immunoassays for Macromolecules
    19. 308 Chromatography-Based Separation of Proteins, Peptides, and Amino Acids
    20. 309 Bioanalytical Method Validation for Macromolecules
    21. 310 Microarrays in Drug Discovery and Development
    22. 311 Genetic Markers and Genotyping Analyses for Genetic Disease Studies
    23. 312 Proteins: Hormones, Enzymes, and Monoclonal Antibodies—Background
    24. 313 Formulation and Delivery Issues of Therapeutic Proteins
    25. 314 Pharmacokinetics
    26. 315 Immunogenicity of Therapeutic Proteins
    27. 316 Development and Characterization of High-Affinity Anti-Topotecan IgG and Fab Fragments
    28. 317 Recombinant Antibodies for Pathogen Detection and Immunotherapy
    29. 318 The Radiopharmaceutical Science of Monoclonal Antibodies and Peptides for Imaging and Targeted In Situ Radiotherapy of Malignancies
    30. 319 Gene Therapy—Basic Principles and the Road from Bench to Bedside
    31. 320 Plasmid DNA and Messenger RNA for Therapy
    32. 321 Formulations and Delivery Limitations of Nucleic-Acid-Based Therapies
    33. 322 Pharmacokinetics Of Nucleic-Acid-Based Therapeutics
    34. 323 Case Studies—Development of Oligonucleotides
    35. 324 RNA Interference: The Next Gene-Targeted Medicine
    36. 325 Delivery Systems For Peptides/Oligonucleotides And Lipophilic Nucleoside Analogs
    37. 326 Growth Factors and Cytokines
    38. 327 Growth Factors, Cytokines, and Chemokines: Formulation, Delivery, and Pharmacokinetics
    39. 328 Protein Engineering with Noncoded Amino Acids: Applications to Hirudin
    40. 329 Production and Purification of Adenovirus Vectors for Gene Therapy
    41. 330 Assessing Gene Therapy By Molecular Imaging
    42. 331 Overview of Stem and Artificial Cells
    43. 332 Regulation of Small-Molecule Drugs Versus Biologicals Versus Biotech Products
    44. 333 Intellectual Property and Biotechnology
    45. 334 Comparability Studies for Later-Generation Products—Plant-Made Pharmaceuticals
    46. 335 Biosimilars
    47. 336 The Promise of Individualized Therapy
    48. 337 Enhanced Proteomic Analysis by HPLC Prefractionation
    49. 338 An Overview of Metabonomics Techniques and Applications
    50. Bioterrorism
  13. Pharmaceutical Manufacturing: Production and Processes
    1. 340 Manufacturing Specialties
    2. 341 Regulatory Considerations in Approval of Follow-On Protein Drug Products
    3. 342 Radiopharmaceutical Manufacturing
    4. 343 Sterile Product Manufacturing
    5. 344 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors
    6. 345 Packaging and Labeling
    7. 346 Clean-Facility Design, Construction, and Maintenance Issues
    8. 347 Solid Dosage Forms
    9. 348 Semisolid Dosages: Ointments, Creams, and Gels
    10. 349 Liquid Dosage Forms
    11. 350 Controlled-Release Dosage Forms
    12. 351 Progress in Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein
    13. 352 Liposomes and Drug Delivery
    14. 353 Biodegradable Nanoparticles
    15. 354 Recombinant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation
    16. 355 Nasal Delivery of Peptide and Nonpeptide Drugs
    17. 356 Nasal Powder Drug Delivery
    18. 357 Aerosol Drug Delivery
    19. 358 Ocular Drug Delivery
    20. 359 Microemulsions as Drug Delivery Systems
    21. 360 Transdermal Drug Delivery
    22. 361 Vaginal Drug Delivery
    23. 362 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powders and Tablet Characterization
    24. 363 Role of Preformulation in Development of Solid Dosage Forms
    25. 364 Tablet Design
    26. 365 Modeling and Informatics in Drug Design
    27. 366 Controlled Release of Drugs from Tablet Coatings
    28. 367 Tablet Compression
    29. 368 Effects of Grinding in Pharmaceutical Tablet Production
    30. 369 Oral Extended-Release Formulations
    31. 370 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field
    32. 371 Nanotechnology in Pharmaceutical Manufacturing
    33. 372 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety
    34. 373 Oil-in-Water Nanosized Emulsions: Medical Applications
  14. Pharmaceutical Manufacturing: Regulations and Quality
    1. 374 Good Manufacturing Practices (GMP) and Related FDA Guidelines
    2. 375 Enforcement of Current Good Manufacturing Practices
    3. 376 Scale-Up and Postapproval Changes (SUPAC) Regulations
    4. 377 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells
    5. 378 National GMP Regulations and Codes and International GMP Guides and Guidelines: Correspondences and Differences
    6. 379 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems
    7. 380 Role of Quality Systems and Audits in Pharmaceutical Manufacturing Environment
    8. 381 Creating and Managing a Quality Management System
    9. 382 Quality Process Improvement
    10. 383 Case for Process Analytical Technology: Regulatory and Industrial Perspectives
    11. 384 Process Analytical Technology
    12. 385 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology
    13. 386 Personnel Training in Pharmaceutical Manufacturing
    14. 387 Origin of Contamination
    15. 388 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatogaphy–Tandem Mass Spectrometry
    16. 389 Microbiology of Nonsterile Pharmaceutical Manufacturing
    17. 390 Stability and Shelf Life of Pharmaceutical Products
    18. 391 Drug Stability
    19. 392 Effect of Packaging on Stability of Drugs and Drug Products
    20. 393 Pharmaceutical Product Stability
    21. 394 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics
    22. 395 Analytical Method Validation: Principles and Practices
    23. 396 Analytical Method Validation and Quality Assurance
    24. 397 Validation of Laboratory Instruments
    25. 398 Pharmaceutical Manufacturing Validation Principles
  15. Drug-Drug Interactions for Therapeutic Biologics
    1. 1 Drug Interactions for Therapeutic Proteins: A Journey Just Beginning
    2. 2 Pharmacokinetic and Pharmacodynamic-Based Drug Interactions for Therapeutic Proteins
    3. 3 Drug Interaction Assessment Strategies: Small Molecules versus Therapeutic Proteins
    4. 4 Model-Independent and Model-Based Methods to Assess Drug–Drug Interactions for Therapeutic Proteins
    5. 5 Utility of In Vitro Methods in Drug–Drug Interaction Assessment and Prediction for Therapeutic Biologics
    6. 6 Use of Animal Models for Projection of Clinical Drug–Drug Interactions for Therapeutic Proteins
    7. 7 The Cocktail Approach and Its Utility in Drug–Drug Interaction Assessments for Therapeutic Proteins
    8. 8 Logistic Considerations in Study Design for Biologic Drug–Drug Interaction Assessments
    9. 9 Statistical Considerations in Assessing Drug–Drug Interactions for Therapeutic Biologics
    10. Scientific Perspectives on Therapeutic Protein Drug–Drug Interaction Assessments
    11. 11 Disease–Drug–Drug Interaction Assessments for Tocilizumab—A Monoclonal Antibody against Interleukin-6 Receptor to Treat Patients with Rheumatoid Arthritis
    12. 12 Drug–Drug Interactions for Etanercept—A Fusion Protein
    13. 13 Drug Interactions of Cytokines and Anticytokine Therapeutic Proteins
    14. 14 Drug Interactions for Growth Factors and Hormones
    15. 15 Drug–Drug Interactions for Nucleic Acid-Based Derivatives
    16. 16 Monographs for Drug-Drug Interactions of Therapeutics Biologics
  16. Nanoparticulate Drug Delivery Systems: Strategies, Technologies, and Applications
    1. 1 Tumor-Targeted Nanoparticles: State-of-the-Art and Remaining Challenges
    2. 2 Applications of Ligand-Engineered Nanomedicines
    3. 3 Lipid Nanoparticles for the Delivery of Nucleic Acids
    4. 4 Photosensitive Liposomes as Potential Targeted Therapeutic Agents
    5. 5 Multifunctional Dendritic Nanocarriers: The Architecture and Applications in Targeted Drug Delivery
    6. 6 Chitosan-Based Nanoparticles for Biomedical Applications
    7. 7 Polymer–Drug Nanoconjugates
    8. 8 Nanocrystals Production, Characterization, and Application for Cancer Therapy
    9. 9 Clearance of Nanoparticles During Circulation
    10. 10 Drug Delivery Strategies for Combating Multiple Drug Resistance
    11. 11 Intracellular Trafficking of Nanoparticles: Implications for Therapeutic Efficacy of the Encapsulated Drug
    12. 12 Toxicological Assessment of Nanomedicine
  17. Biological Drug Products: Development and Strategies
    1. An Overview of the Discovery and Development Process for Biologics
    2. Nonclinical Safety Assessment of Biologics, Including Vaccines
    3. Clinical Assessment of Biologic Agents
    4. Key Regulatory Guidelines for the Development of Biologics in the United States and Europe1
    5. Landscape and Consideration of Intellectual Property for Development of Biosimilars
    6. Scientific Aspects of Sterility Assurance, Sterility, Asepsis, and Sterilization
    7. Cell Culture Processes in Monoclonal Antibody Production
    8. Protein and Peptide Purification
    9. Chemical and Genetic Modification
    10. Analytical Characterization of Proteins and Peptides
    11. Protein and Peptide Formulation Development
    12. Regulatory Strategies and Lessons in the Development of Biosimilars
    13. Vaccine Development: History, Current Status, and Future Trends
    14. Role and Application of Adjuvants and Delivery Systems in Vaccines
    15. Methods for Characterizing Proteins in Aluminum Adjuvant Formulations
    16. The State of the Art and Future of Gene Medicines
    17. Nucleic Acid Vaccines
    18. Multifunctional Polymeric Nanosystems for RNA Interference Therapy
    19. Advent and Maturation of Regenerative Medicine
    20. Conventional and Novel Container Closure and Delivery Systems
    21. Controlled-Release Systems for Biologics
    22. Routes of Delivery for Biological Drug Products

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