17. From the Lab to the Clinic: Filing a Phase I IND for an Investigational Vaccine

  1. Manmohan Singh and
  2. Indresh K. Srivastava
  1. Kenneth G. Surowitz

Published Online: 6 JUN 2011

DOI: 10.1002/9781118023648.ch17

Development of Vaccines: From Discovery to Clinical Testing

Development of Vaccines: From Discovery to Clinical Testing

How to Cite

Surowitz, K. G. (2011) From the Lab to the Clinic: Filing a Phase I IND for an Investigational Vaccine, in Development of Vaccines: From Discovery to Clinical Testing (eds M. Singh and I. K. Srivastava), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9781118023648.ch17

Editor Information

  1. Novartis Vaccines, Cambridge, Massachusetts, USA

Author Information

  1. Merck Research Laboratories, North Wales, Pennsylvania, USA

Publication History

  1. Published Online: 6 JUN 2011
  2. Published Print: 18 JUL 2011

ISBN Information

Print ISBN: 9780470256374

Online ISBN: 9781118023648

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Keywords:

  • lab to clinic, filing phase I investigational new drug (IND) - trials for vaccine in United States;
  • general investigational plan (GIP), and pre-IND meeting package needs - 4 weeks before the meeting;
  • chemistry, manufacturing, and control (CMC) information - FDA and “quality, purity and strength of investigational drug”

Summary

This chapter contains sections titled:

  • Introduction

  • The Pre-IND Meeting

  • Request Letter for a Pre-IND Meeting

  • Pre-IND Meeting Package (Background Package)

  • Conduct of the Pre-IND Meeting

  • Filing the IND

  • General Investigational Plan

  • Investigator's Brochure

  • Chemistry, Manufacturing, and Control (CMC) Information

  • Pharmacology and Toxicology Information

  • Other Information

  • After Filing the IND

  • References