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Rubicon Publications

Publish a Book Chapter in "Advances in Drugs Research for Discovery, Development and Safety (Volume - 1)"

Call for Book Chapters: Submissions Now Open

978-1-80433-859-9

Drugs Edited Book | Edited Book on Pharmaceutical Science


This edited book on drugs titled "Advances in Drugs Research for Discovery, Development and Safety" mainly focuses on various topics such as drug discovery pipelines, target identification, target validation etc., and the rest are given below in the Scope of the book. This pharmaceutical science edited book will be published with ISBN numbers after following a proper double blind peer reviewed process. All the chapters of this drugs edited book will be published in a proper style, so that reader can easily understand and learn.

Author can download this drugs edited book titled "Advances in Drugs Research for Discovery, Development and Safety" authorship responsibility and copyright form: Click Here

Indexed In


Indexed in Crossref Indexed in Dimensions Indexed in Bowker
Invited Topics

  1. Preclinical Toxicology Programs for First-in-Human Readiness
  2. Safety Pharmacology and Cardiovascular Risk Assessment
  3. Genotoxicity Testing and Regulatory Decision Making
  4. Carcinogenicity Evaluation and Long-Term Safety Requirements
  5. Reproductive and Developmental Toxicology in Drug Development
  6. Immunotoxicity and Hypersensitivity Risks in Therapeutics
  7. Drug–Drug Interaction Evaluation and Clinical Management Strategies
  8. CYP Enzymes and Metabolic Pathways in Interaction Risk
  9. Transporters and Their Roles in Drug Absorption and Clearance
  10. Selecting Starting Doses for First-in-Human Trials
  11. Phase I Trial Designs, Biomarkers, and Safety Monitoring
  12. Phase II Proof-of-Concept Studies and Endpoint Selection
  13. Phase III Pivotal Trials: Design, Execution, and Interpretation
  14. Adaptive Trial Designs and Platform Trials in Modern Development
  15. Decentralized and Hybrid Clinical Trials: Opportunities and Limitations
  16. Patient Safety Monitoring, DSMBs, and Trial Governance
  17. Statistical Methods for Clinical Development and Decision Making
  18. Real-World Evidence: Data Sources and Regulatory Use Cases
  19. Benefit–Risk Assessment Frameworks for Regulatory Decisions
  20. Pharmacovigilance Systems and Global Safety Reporting Requirements
  21. Signal Detection Methods in Spontaneous Reporting Databases
  22. Risk Management Plans and Post-Authorization Safety Studies
  23. Medication Errors and Safety-by-Design in Product Development
  24. Quality by Design in Drug Development and Manufacturing
  25. GMP Compliance and Quality Systems in Pharmaceutical Production
  26. Analytical Method Development and Validation for New Drugs
  27. Stability Studies and Shelf-Life Determination
  28. Impurity Profiling, Genotoxic Impurities, and Control Strategies
  29. Detecting Counterfeit and Substandard Medicines in Supply Chains
  30. Regulatory Submissions: CTD Structure and Common Pitfalls
  31. Translational Medicine and Bridging Preclinical to Clinical Evidence
  32. Model-Informed Drug Development and Regulatory Interactions
  33. Pediatric Drug Development and Ethical Considerations
  34. Geriatric Pharmacology and Dosing Considerations in Trials
  35. Sex Differences in Drug Response and Clinical Trial Design
  36. Ethnopharmacology and Population PK Across Diverse Groups
  37. Orphan Drugs and Development Pathways for Rare Diseases
  38. Accelerated Approval Pathways and Conditional Marketing Authorizations
  39. Companion Diagnostics and Targeted Therapy Co-Development
  40. Drug Repurposing Strategies and Evidence Standards
  41. Computational Chemistry Tools for Lead Discovery and Optimization
  42. Chemical Biology Approaches for Target Validation
  43. Toxicogenomics and Biomarkers of Organ Toxicity
  44. In Vitro Models, Organoids, and Microphysiological Systems
  45. Animal Model Selection and Translational Relevance
  46. Bioequivalence Studies and Generic Drug Development
  47. Biopharmaceutics and In Vitro–In Vivo Correlation Models
  48. Nanomedicine and Safety Assessment for Novel Delivery Platforms
  49. Immuno-Oncology Drug Development: Special Safety Considerations
  50. Antimicrobial Drug Development and Resistance Challenges
  51. Antiviral Drug Development and Emerging Pathogens
  52. CNS Drug Development: Blood–Brain Barrier Challenges
  53. Cardiometabolic Drug Development and Long-Term Outcomes
  54. Safety Endpoints and Surrogate Endpoints in Clinical Development
  55. Patient-Reported Outcomes and Their Use in Labeling Claims
  56. Clinical Trial Diversity and Inclusive Recruitment Strategies
  57. Data Integrity, Audits, and Inspection Readiness in Trials
  58. Ethics, Informed Consent, and Participant Protection in Research
  59. Pharmacoeconomics and Value Demonstration for New Drugs
  60. Health Technology Assessment and Market Access Evidence
  61. Drug Pricing, Access, and Policy Considerations for Innovation
  62. Post-Marketing Effectiveness Studies Using Observational Methods
  63. Pregnancy Registries and Safety Monitoring in Special Populations
  64. Signal Management and Safety Communication to Stakeholders
  65. Benefit–Risk Communication and Patient Information Leaflets
  66. Post-Approval Manufacturing Changes and Comparability Studies
  67. Continuous Manufacturing and Modern Quality Approaches
  68. Supply Chain Resilience and Shortage Prevention Strategies
  69. Lifecycle Management: New Indications and Formulation Line Extensions
  70. Intellectual Property Strategy and Patent Landscape Considerations
  71. Regulatory Science Trends and Harmonization Initiatives
  72. Artificial Intelligence for Clinical Trial Design and Recruitment
  73. Digital Biomarkers and Novel Endpoints in Drug Development
  74. Wearables and Remote Monitoring for Safety Data Collection
  75. Standards for Data Sharing and Transparency in Drug Development
  76. Reproducibility and Robustness in Preclinical Research
  77. Case Studies in Successful Drug Development Programs
  78. Failure Analysis in Drug Development and Risk Mitigation
  79. Future Trends in Drug Discovery, Development, and Safety
  80. Roadmap for Responsible and Patient-Centered Drug Innovation
Book Scope

  • Drug Discovery Pipelines
  • Target Identification
  • Target Validation
  • Hit Screening Methods
  • Lead Optimization
  • Structure-Based Design
  • QSAR Modeling
  • AI in Drug Discovery
  • Omics-Driven Targets
  • Biomarker Discovery
  • ADME Screening
  • PK Studies
  • PD Modeling
  • Dose Selection
  • Formulation Design
  • Drug Delivery Systems
  • Prodrugs Development
  • Biologics Development
  • Biosimilars Pathways
  • Gene Therapy Basics
  • Vaccine Development
  • Preclinical Toxicology
  • Safety Pharmacology
  • Genotoxicity Testing
  • Carcinogenicity Studies
  • Reproductive Toxicology
  • Immunotoxicity
  • Drug–Drug Interactions
  • CYP Enzyme Studies
  • Transporter Studies
  • First-in-Human Trials
  • Phase I Design
  • Phase II Endpoints
  • Phase III Methods
  • Adaptive Trial Design
  • Real-World Evidence
  • Pharmacovigilance Systems
  • Signal Detection
  • Risk Management Plans
  • Benefit–Risk Assessment
  • Quality by Design
  • GMP Compliance
  • Analytical Validation
  • Stability Studies
  • Impurity Profiling
  • Counterfeit Detection
  • Regulatory Submissions
  • Ethics in Trials
  • Patient Safety Monitoring
  • Post-Marketing Studies


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Deadline

31 Jan 2026