Early Drug Development Strategies and Routes to First-in-Human Trials [Hardcover]

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.Contributors.

Foreward.

Preface.

PART I INTRODUCTION.

1 Drug Discovery and Early Drug Development (Mitchell N. Cayen).

1.1 The Drug Discovery and Development Scene.

1.2 Drug Discovery.

1.3 Pre-FIH Drug Development.

1.4 The FIH Trial.

1.5 The Regulatory Landscape.

1.6 Contract Research Organizations.

1.7 Concluding Remairs to Introductory Perspectives.

References.

PART II LEAD OPTIMIZATION STRATEGIES.

2 ADME Strategies in Lead Optimization (Amin A. Nomeir).

2.1 Introduction.

2.2 Absorption.

2.3 Distribution.

2.4 Metabolism.

2.5 Excretion.

2.6 Pharmacokinetics.

2.7 Prioritizing ADME Screens.

2.8 In Silico ADME Screening.

2.9 The Promise of Metabolomics.

2.10 Conclusions.

References.

3 Prediction of Pharmacokinetics and Dl3^