Early Drug Development: Strategies and Routes to First-in-Human Trials - ISBN:0470170867

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

Date: 15 April 2011, 13:13

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Learn how to improve your odds of developing a successful drug candidate
Drug development is a highly resource intensive effort. The high attrition rate during nonclinical and especially clinical evaluation demands that the candidate drug selection process be as cost and time effective as possible. Focusing on the critical early stages of drug development, this book guides investigators through the continuum of disciplines that play a role in determining whether a new chemical entity with demonstrated pharmacological activity should progress to clinical evaluation in human subjects. Moreover, it will help them prepare and submit an Investigational New 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 Regulatory Submission
Each chapter, written by a leading expert, examines a specific discipline, such as ADME and pharmacokinetics, bioanalysis, safety pharmacology, toxicology and toxicokinetics, chemistry/manufacturing and controls (CMC), and exploratory INDs. Authors explore strategies, study designs, challenges, and decision-making criteria for both small molecules and, where relevant, biopharmaceutics, offering specific examples for illustration. They also discuss the interdisciplinary coordination needed to develop a candidate drug that has the best potential of demonstrating a high level of efficacy and safety in its target patient population. In addition, most chapters guide readers through relevant international regulatory guidelines and requirements to help streamline the approval process.
This book is recommended for all investigators involved in nonclinical and clinical drug development, helping them focus their scientific efforts and resources on the best drug candidates and mini

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