Table of contents

  1. Front Matter
    Pages i-xii
  2. Jan Willem van der Laan, Joseph J. DeGeorge
    Pages 1-12
  3. Spiros Vamvakas
    Pages 13-21
  4. Jan Willem van der Laan, Joseph J. DeGeorge, Frank Sistare, Jonathan Moggs
    Pages 37-75
  5. Lutz Müller, David Tweats, Sheila Galloway, Makoto Hayashi
    Pages 77-118
  6. Per Spindler, Herman Van Cauteren
    Pages 159-174
  7. John E. Koerner, Peter K. S. Siegl
    Pages 243-265
  8. Kenneth L. Hastings
    Pages 267-281
  9. Back Matter
    Pages 311-315

About this book

Introduction

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the US and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA). In Europe, the members are the EU (Representatives of the European Commission and the European Medicines Agency [EMA]), and the European Federation of Pharmaceutical Industries and Associations (EFPIA). In the United States, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). The International Federation of Pharmaceutical Manufacturers Associations (IFPMA)  is the secretariat of the ICH. Additional members include Observers from WHO, European Free Trade Association (EFTA), and Canada. The Observers represent non-ICH countries and regions.

 

This volume considers one of  ICH’s major categories, Safety,  covering topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but  in most cases  there is a lack of awareness of the many issues that were addressed during the development of the consensus guidances. Further, just as it is important to understand what the guidances state, it is also important to understand the thoughts, debates, and intent of the experts involved, which are not included in the guidance documents. Why has the guideline been written as it is written,  why are some topics ignored, and  why have some initial guidance proposals have  been deleted. These and other related questions and answers are the contents of this book, written by experts who were directly involved in writing the ICH guidances that drive drug development today.

Keywords

DeGeorge Guideline ICH Laan Safety

Editors and affiliations

  • Jan Willem van der Laan
    • 1
  • Joseph J. DeGeorge
    • 2
  1. 1., Section on Pharmacology, Toxicology, andMedicines Evaluation BoardUtrechtNetherlands
  2. 2., Drug Safety TestingMerck Research LaboratoriesWest PointUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4614-5950-7
  • Copyright Information American Association of Pharmaceutical Scientists 2013
  • Publisher Name Springer, New York, NY
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-1-4614-5949-1
  • Online ISBN 978-1-4614-5950-7
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • About this book

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