Early Drug Development: Strategies and Routes to First-in-Human Trials

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9780470170861: Early Drug Development: Strategies and Routes to First-in-Human Trials
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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.

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From the Back Cover:

Learn how to improve your odds of developing a successful drugcandidate

Drug development is a highly resource intensive effort. The highattrition rate during nonclinical and especially clinicalevaluation demands that the candidate drug selection process be ascost and time effective as possible. Focusing on the critical earlystages of drug development, this book guides investigators throughthe continuum of disciplines that play a role in determiningwhether a new chemical entity with demonstrated pharmacologicalactivity should progress to clinical evaluation in human subjects.Moreover, it will help them prepare and submit an InvestigationalNew Drug (IND) application.

The book is divided into five parts:

  • Part I: Introduction
  • Part II: Lead Optimization Strategies
  • Part III: Bridging from Discovery to Development
  • Part IV: Pre-IND Drug Development
  • Part V: Planning the First-in-Human Study and RegulatorySubmission

Each chapter, written by a leading expert, examines a specificdiscipline, such as ADME and pharmacokinetics, bioanalysis, safetypharmacology, toxicology and toxicokinetics,chemistry/manufacturing and controls (CMC), and exploratory INDs.Authors explore strategies, study designs, challenges, anddecision-making criteria for both small molecules and, whererelevant, biopharmaceutics, offering specific examples forillustration. They also discuss the interdisciplinary coordinationneeded to develop a candidate drug that has the best potential ofdemonstrating a high level of efficacy and safety in its targetpatient population. In addition, most chapters guide readersthrough relevant international regulatory guidelines andrequirements to help streamline the approval process.

This book is recommended for all investigators involved innonclinical and clinical drug development, helping them focus theirscientific efforts and resources on the best drug candidates andmini

About the Author:

MITCHELL N. CAYEN, PhD, is Principal of Cayen Pharmaceutical Consulting, LLC, a firm that advises pharmaceutical companies in nonclinical and clinical drug develop-ment, with specific focus on candidate drug selection, discovery, drug metabolism and pharmacokinetics, drug development strategies, and regulatory submissions. Previously, he was senior director of drug metabolism and pharmacokinetics at Schering-Plough Research Institute.

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