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Early Drug Development Strategies and Routes to First in Human Trials 1st Edition by Mitchell Cayen ISBN 0470170867 9780470170861

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Early Drug Development Strategies and Routes to First in Human Trials 1st Edition Mitchell N. Cayen Digital Instant Download

Author(s): Mitchell N. Cayen
ISBN(s): 9780470613177, 0470613173
Edition: 1
File Details: PDF, 3.16 MB
Year: 2010
Language: english
SKU: EB-1789048 Category: Tag:

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Product details:
ISBN 10: 0470170867
ISBN 13: 9780470170861
Author:  Mitchell Cayen

The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Early Drug Development Strategies and Routes to First in Human Trials 1st Edition Table of contents:

  • Chapter 1: The Drug Development Process

    • Overview of the pharmaceutical development lifecycle.
    • Phases of drug development from preclinical research to clinical trials.
    • Importance of regulatory agencies and their role in drug development.

  • Chapter 2: Drug Discovery and Preclinical Development

    • The process of identifying drug candidates: target identification, screening, and lead optimization.
    • Animal studies, in vitro assays, and safety pharmacology.
    • Toxicology and the transition from preclinical to clinical trials.

  • Chapter 3: Regulatory Considerations for Early Development

    • Role of agencies like the FDA, EMA, and other global regulators in early-stage drug development.
    • Investigational New Drug (IND) applications and regulatory submissions.
    • Guidance for initiating clinical trials and early clinical development.

  • Chapter 4: Designing Early Clinical Trials

    • Objectives and structure of Phase I clinical trials.
    • Defining safe dosage ranges, pharmacokinetics, and pharmacodynamics.
    • First-in-human (FIH) trials: ethical considerations, patient recruitment, and risk management.

  • Chapter 5: Selecting the Right Route of Administration

    • Routes to administer a drug: oral, intravenous, subcutaneous, etc.
    • Factors influencing the choice of drug delivery method.
    • The importance of formulation in early drug development.

  • Chapter 6: Biomarkers and Surrogate Endpoints

    • Role of biomarkers in assessing drug efficacy and safety.
    • Use of surrogate endpoints in early trials to predict clinical outcomes.
    • Advancements in personalized medicine and precision therapeutics.

  • Chapter 7: Pharmacokinetics and Pharmacodynamics in Early Trials

    • Understanding absorption, distribution, metabolism, and excretion (ADME) profiles.
    • Exploring the relationship between drug concentration and therapeutic effects.
    • Modeling and simulation in early-phase clinical trials.

  • Chapter 8: Safety Assessment and Risk Management

    • Adverse event reporting, monitoring, and analysis in Phase I trials.
    • Assessing long-term safety risks and mitigating potential issues.
    • Safety concerns in special populations (e.g., pediatric, elderly, pregnant women).

  • Chapter 9: Case Studies in First-in-Human Trials

    • Real-world examples of successful and challenging First-in-Human trials.
    • Key lessons learned from early drug development and trial outcomes.
    • How case studies shape the approach to future drug development.

  • Chapter 10: Ethical Considerations in Early Drug Development

    • Ethical dilemmas in human trials: informed consent, participant safety, and regulatory oversight.
    • Balancing scientific progress with the protection of trial participants.
    • The role of institutional review boards (IRBs) and ethics committees.

  • Chapter 11: Advancements in Early Drug Development Technologies

    • Innovations in drug development tools: high-throughput screening, in silico models, and organ-on-a-chip technologies.
    • The role of artificial intelligence and machine learning in predicting outcomes.
    • The future of biomarker discovery and diagnostic tools for drug development.

  • Chapter 12: Global Perspectives on Early Drug Development

    • Differences in regulatory requirements across regions.
    • The challenges and opportunities of conducting multinational clinical trials.
    • Harmonization of regulatory processes and international collaboration.

  • Chapter 13: Challenges and Future Trends in Early Drug Development

    • Current challenges in early drug development: cost, time, and attrition rates.
    • Emerging trends in personalized medicine, gene therapy, and biologics.
    • The evolving landscape of early-stage clinical trials.

  • Conclusion: Pathways to Success in Early Drug Development

    • Summary of key takeaways and recommendations for pharmaceutical professionals.
    • The importance of continued innovation and adaptation in drug development strategies.
    • Preparing for the future of clinical trials and drug approval.

  • Appendices

    • Glossary of terms and definitions.
    • Sample documents (e.g., trial protocols, IND application templates).
    • Additional resources for further reading.

  • References

    • Comprehensive list of all scientific and regulatory sources cited throughout the book.

  • Index

    • An alphabetical listing of key terms, methodologies, and concepts discussed in the book.

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