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Pharmaceutical Book from C.H.I.P.S.

Early Drug Development
Strategies and Routes to First-in-Human Tials
edited by Mitchell N. Cayen

Early Drug Development 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.

Contents

Part 1: Introduction

1. Drug Discovery and Early Drug Development

  • The Drug Discovery and Development Scene
  • Drug Discovery
  • Pre-FIH Drug Development
  • The FIH Trial
  • The Regulatory Landscape
  • Contract Research Organizations (CROs)
  • Concluding Remairs to Introductory Perspectives

Part 2: Lead Optimization Strategies

2. ADME Strategies in Lead Optimization

  • Introduction
  • Absorption
  • Distribution
  • Metabolism
  • Excretion
  • Pharmacokinetics
  • Prioritizing ADME Screens
  • In Silico ADME Screening
  • The Promise of Metabolomics

3. Prediction of Pharmacokinetics and Drug Safety in Humans
  • Introduction
  • Prediction of Human Pharmacokinetic Behavior
  • Prediction of Drug Safety

4. Bioanalytical Strategies
  • Introduction
  • Basic Bioanalytical Techniques and Method Development
  • Bioanalytical Method Validation
  • Special Issues with Ligand Binding Assay
  • Partial and Cross Validations
  • Application of Validated Methods to Sample Analyses: Some
  • Risk Based Paradigms: Discovery and Development Support
  • Road to "First in Human"
  • International Perspectives

Part 3: Bridging from Discovery to Development

5. Chemistry, Manufacturing and Controls - The Drug Substance and Formulated Drug Product

  • Introduction
  • Pre-NCE Activities and NCE Development
  • CMC Consideration at the NCE Stage
  • NCE to GLP Transition (Bridging from Discovery to Pre-FIH Development)
  • CMCs to Meet Clinical Trial Material (CTM) Requirements
  • CMC Strategic Considerations
  • Case Studies
  • Evolution of Drug Development in the 21st Century: Implications for CMCs in the Future

6. Preclinical Safety Pharmacology Studies Recommended for Supporting First-in-Human (FIH) Clinical Trials
  • Introduction and Overview
  • Timing of Safety Pharmacology Studies
  • CNS Safety Pharmacology
  • Cardiovascular Safety Pharmacology
  • Respiratory System Safety Pharmacology
  • Renal/Urinary Safety Pharmacology
  • Gastrointestinal System Safety Pharmacology
  • Autonomic Nervous System Safety Pharmacology
  • Other Systems
  • Discussion and Conclusion

Part 4: Pre-IND Drug Development

7. Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine

  • Toxicology Support of Discovery
  • Goals of the Pre-FIH Toxicology Program
  • Importance of a Clinical Review of the Nonclinical Pharmacology Data
  • Take the Time to Plan Appropriately
  • The Active Pharmaceutical Ingredient (API)
  • Timely Conduct of In Vitro Assays
  • Development of Validated Bioanalytical and Analytical Assays
  • Planning for the Conduct of Toxicity Studies
  • The Pre-IND Meeting

8. Toxicokinetics in Support of Drug Development
  • Introduction
  • Historical Perspectives
  • Regulatory Considerations
  • Factors to Consider in the Design of Toxicokinetic Studies
  • Toxicokinetic Parameter Estimates and Calculations
  • Interpretation of Toxicokinetic Data
  • Role of Toxicokinetics in Different Types of Toxicity Studies
  • Role of Toxicokinetics in Integrated Safety Assessment

9. Good Laboratory Practices
  • Introduction
  • Hazard and Risk
  • The US GLP Regulations
  • GLPs in the Bioanalytical Laboratory
  • Moving into the Future: a Closing Overview

10. Estimation of Starting Dose for Phase I Clinical Programs
  • Introduction
  • Characteristics of Well Behaved Therapeutic Candidates
  • Regulatory Guidances for FIH-Enabling Preclinical Safety Assessment: General Principles
  • Preclinical Pharmacokinetics (PK) and Pharmacodynamics (PD) for Human Dose Projection
  • Establishing the First-in-Human Dose
  • Phase I Clinical Trial Support: Use of MABEL or Pharmacologically Active Dose (PAD)
  • Support of ?Exploratory? Clinical Studies
  • Considerations in the Design of Phase I Trials
  • Interdisciplinary Partnerships
  • Beyond the FIH Dose
  • Concluding Perspective
  • Four Case Studies

Part 5: Planning the First-in-Human Study and Regulatory Submission

11. Exploratory INDs/CTAs

  • Introduction
  • Regulatory Background
  • Experience and Various Perspectives on ExpINDs or ExpCTAs
  • Some Reactions and Perspectives on the ExpIND/ExpCTA Initiative
  • What is an Ideal Candidate for an ExpIND/ExpCTA

12. Unique Considerations for Biopharmaceutics
  • Introduction and Background
  • election of the Molecule: Contrasts to Small Molecule Considerations
  • Production and Process Considerations in Pre-FIH Development
  • Bioanalytical Assay Considerations
  • Objectives and Implementation of Pre-FIH Safety Assessment Programs
  • Post-IND Considerations: Support of Phase II, III and Registration
  • The TeGenero Incident and Implications for Biopharmaceutic Preclinical Safety Evaluation Programs

13. Project Management and International Regulatory Requirements for First-in-Human Trials
  • Introduction: Initiate Product Development with the "End in Mind"
  • Importance of Project Management
  • FDA Input Early and Often
  • The (US) IND Submission
  • Global Clinical Trials
  • The Clinical Trial Application (CTA)

14: First-in-Human Regulatory Submissions
  • Introduction
  • Submission Strategies
  • First-in-Human Dossiers
  • United States: Investigational New Drug Application (IND)
  • European Union: Clinical Trial Application (CTA)
  • Japan: Clinical Trial Protocol Notification (CTPN)
  • Emerging Regions
  • Biopharmaceuticals
  • Final Considerations

Appendix 1: List of Abbreviations

Appendix 2: Definitions and Glossary of Terms

Appendix 3: Some Relevant Government and Regulatory Documents

Appendix 4: Some Relevant Resources with Web Sites

Index

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Early Drug Development
Strategies and Routes to First-in-Human Trials
edited by Mitchell N. Cayen

2010 • 630 pages • $148.95 + shipping
Texas residents please add 6.75 % sales tax

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