The IND Application

John W. Ferkany1, Michael Williams2

1 Surface Logix, Brighton, Massachusetts, 2 Cephalon, Inc., West Chester, Pennsylvania
Publication Name:  Current Protocols in Pharmacology
Unit Number:  Unit 9.10
DOI:  10.1002/0471141755.ph0910s42
Online Posting Date:  September, 2008
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Abstract

Translational biomedical research is often directed to the introduction of a new drug or biologic intended to treat unmet medical need in humans. This unit describes the timing and content of the investigational new drug (IND) application, the primary document required by the U.S. FDA for the initiation of clinical trials in humans with any new chemical entity (NCE) or biologic. The IND application contains all the information necessary for the FDA to make an assessment of the risks and benefits of the proposed clinical trials for the NCE/biologic, containing a detailed but succinct description of the biology, safety, toxicology, chemistry and manufacturing process, and the proposed clinical plan. This unit is geared for those with little or no experience with the IND process and is intended as a global introduction to this, the initial stage of the drug development process for drugs used in humans. Curr. Protoc. Pharmacol. 42:9.10.1‐9.10.23. © 2008 by John Wiley & Sons, Inc.

Keywords: CMC; GLP; GMP; drug development; clinical trials; QT prolongation; ICH; efficacy; side effects; investigator's brochure; IRB; FDA; animal models

     
 
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Table of Contents

  • Investigational New Drug Applications
  • Types Of INDs
  • Timing of the IND
  • The Pre‐IND Meeting
  • Format and Contents of the IND (21 CFR 312.23)
  • Filing the IND
  • Follow‐Up to the IND
  • Exploratory INDs
  • Regulations and Laws Governing The IND
  • Useful Links
  • Tables
     
 
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Materials

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Literature Cited

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