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Publish a Book Chapter in "Advances in Drugs Research for Discovery, Development and Safety (Volume - 1)"
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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.
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Indexed In
Invited Topics
Preclinical Toxicology Programs
for First-in-Human Readiness
Safety Pharmacology and
Cardiovascular Risk Assessment
Genotoxicity Testing and
Regulatory Decision Making
Carcinogenicity Evaluation and
Long-Term Safety Requirements
Reproductive and Developmental
Toxicology in Drug Development
Immunotoxicity and
Hypersensitivity Risks in Therapeutics
Drug–Drug Interaction Evaluation
and Clinical Management Strategies
CYP Enzymes and Metabolic
Pathways in Interaction Risk
Transporters and Their Roles in
Drug Absorption and Clearance
Selecting Starting Doses for
First-in-Human Trials
Phase I Trial Designs,
Biomarkers, and Safety Monitoring
Phase II Proof-of-Concept Studies
and Endpoint Selection
Phase III Pivotal Trials: Design,
Execution, and Interpretation
Adaptive Trial Designs and
Platform Trials in Modern Development
Decentralized and Hybrid Clinical
Trials: Opportunities and Limitations
Patient Safety Monitoring, DSMBs,
and Trial Governance
Statistical Methods for Clinical
Development and Decision Making
Real-World Evidence: Data Sources
and Regulatory Use Cases
Benefit–Risk Assessment
Frameworks for Regulatory Decisions
Pharmacovigilance Systems and
Global Safety Reporting Requirements
Signal Detection Methods in
Spontaneous Reporting Databases
Risk Management Plans and
Post-Authorization Safety Studies
Medication Errors and Safety-by-Design
in Product Development
Quality by Design in Drug
Development and Manufacturing
GMP Compliance and Quality
Systems in Pharmaceutical Production
Analytical Method Development and
Validation for New Drugs
Stability Studies and Shelf-Life
Determination
Impurity Profiling, Genotoxic
Impurities, and Control Strategies
Detecting Counterfeit and
Substandard Medicines in Supply Chains
Regulatory Submissions: CTD
Structure and Common Pitfalls
Translational Medicine and
Bridging Preclinical to Clinical Evidence
Model-Informed Drug Development
and Regulatory Interactions
Pediatric Drug Development and
Ethical Considerations
Geriatric Pharmacology and Dosing
Considerations in Trials
Sex Differences in Drug Response
and Clinical Trial Design
Ethnopharmacology and Population
PK Across Diverse Groups
Orphan Drugs and Development
Pathways for Rare Diseases
Accelerated Approval Pathways and
Conditional Marketing Authorizations
Companion Diagnostics and
Targeted Therapy Co-Development
Drug Repurposing Strategies and Evidence
Standards
Computational Chemistry Tools for
Lead Discovery and Optimization
Chemical Biology Approaches for
Target Validation
Toxicogenomics and Biomarkers of
Organ Toxicity
In Vitro Models, Organoids, and
Microphysiological Systems
Animal Model Selection and
Translational Relevance
Bioequivalence Studies and
Generic Drug Development
Biopharmaceutics and In Vitro–In
Vivo Correlation Models
Nanomedicine and Safety
Assessment for Novel Delivery Platforms
Immuno-Oncology Drug Development:
Special Safety Considerations
Antimicrobial Drug Development
and Resistance Challenges
Antiviral Drug Development and
Emerging Pathogens
CNS Drug Development: Blood–Brain
Barrier Challenges
Cardiometabolic Drug Development
and Long-Term Outcomes
Safety Endpoints and Surrogate
Endpoints in Clinical Development
Patient-Reported Outcomes and
Their Use in Labeling Claims
Clinical Trial Diversity and
Inclusive Recruitment Strategies
Data Integrity, Audits, and
Inspection Readiness in Trials
Ethics, Informed Consent, and
Participant Protection in Research
Pharmacoeconomics and Value
Demonstration for New Drugs
Health Technology Assessment and
Market Access Evidence
Drug Pricing, Access, and Policy
Considerations for Innovation
Post-Marketing Effectiveness
Studies Using Observational Methods
Pregnancy Registries and Safety
Monitoring in Special Populations
Signal Management and Safety
Communication to Stakeholders
Benefit–Risk Communication and
Patient Information Leaflets
Post-Approval Manufacturing
Changes and Comparability Studies
Continuous Manufacturing and
Modern Quality Approaches
Supply Chain Resilience and
Shortage Prevention Strategies
Lifecycle Management: New
Indications and Formulation Line Extensions
Intellectual Property Strategy
and Patent Landscape Considerations
Regulatory Science Trends and
Harmonization Initiatives
Artificial Intelligence for
Clinical Trial Design and Recruitment
Digital Biomarkers and Novel
Endpoints in Drug Development
Wearables and Remote Monitoring
for Safety Data Collection
Standards for Data Sharing and
Transparency in Drug Development
Reproducibility and Robustness in
Preclinical Research
Case Studies in Successful Drug
Development Programs
Failure Analysis in Drug
Development and Risk Mitigation
Future Trends in Drug Discovery,
Development, and Safety
Roadmap for Responsible and Patient-Centered
Drug Innovation