Toxicology and Pharmacology

Outsourcing, History, Process and Regulation; Technical, Political and Economic Challenges

Publication Date January 2010
ISBN n/a
Pages 150
Tables n/a
Figures n/a

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This report is essential reading for everyone involved in clinical trials and drug development including senior staff in pharmaceutical companies and CROs.

Toxicology and pharmacology are challenging areas in the clinical trial process. Although the results gained are vital for the safety of medicines and are required by regulatory bodies around the world, the processes involved, especially animal testing, remain controversial. Almost all of the work is outsourced and the major companies involved have come under considerable pressure from activist groups.

This 150 page report gives a detailed analysis of the market and of the issues involved. Contents include:

  • The development of toxicology
  • A review of the major companies involved
  • Principles and practices in outsourcing
  • Essentials of a contract
  • Negotiation
  • Regulatory environment
  • USA
  • Europe
  • Japan
  • ICH
  • GLP
  • The pre-clinical market
  • Non-animal testing
  • Validating organisations
  • Validation studies
  • Future Challenges
  • Technical
  • Economic

Written by industry experts Dr Graham Hughes and Dr Richard Barrett the report will enable you to:

  • Understand the processes and issues
  • Manage the outsourcing process
  • Assess the toxicology market
  • Analyse challenges for the future
  • Understand the global regulatory environment
  • Assess the major providers

Outsourcing Toxicology and Pharmacology is essential reading for everyone involved in clinical trials and drug development including senior staff in pharmaceutical companies and CROs, trial managers and staff and those staff directly involved in toxicology and pharmacology testing, product, process and analytical development, R&D, and regulatory affairs. It is aimed at biotech, big pharma, CROs, providers of analytical services and regulatory agencies. The report gives an authoritative, detailed and clear explanation of the issues surrounding toxicology testing, its implications for the market and for the biotech and pharmaceutical industries.

Preface

Chapter 1: Introduction to Toxicology and its Outsourcing
     Pre-Industrial Toxicology
     Toxicology & the Chemical Industrial Revolution
     Toxicity Testing
     Toxicology Terminology

Chapter 2: Principles and Practices in Outsourcing Toxicology
     Introduction
     How to Outsource
     Essentials of a Contract
     Negotiation

Chapter 3: Outsourcing of Toxicology - A Potted History
     Covance Inc
     Life Science Research Inc (Huntingdon Laboratories)
     Charles River
     Harlan
     NOTOX
     Sequani
     Laboratory of Pharmacology & Toxicology (LPT)
     CIT

Chapter 4: Review of Selected Major CROs


Chapter 5: Summary of the Regulatory Environment
     USA
     Europe
     Japan
     Good Laboratory Practice (GLP)
     GLP & Outsourcing

Chapter 6: The Preclinical Market
     REACH
     Preclinical CROs by Country
     Rate of Formation of Toxicology CROs
     Market Size Analysis

Chapter 7: The Use of Non Animal Testing in Toxicology
     Introduction
     Validation Organisations
     Validation Studies
    The Validation Process

Chapter 8: Conclusions and Future Challenges
     Introduction
     Technical Challenges
     Genomics
     Proteomics
     Metabolomics
     Biomarkers
     Biopharmaceuticals
     Political Challenges
     Afterword

Appendix: Profiles of Preclinical and Toxicology CROs
     Accelera (Italy)
     Advinus (India)
     Aptuit (USA)
     Charles River (Edinburgh)
     CIT (France)
     Covance (USA)
     Harlan (USA) (Including SafePharm (UK) and RCC (Switzerland})
     LSR (Huntingdon)
     ITR (Canada)
     LAB Research (Including ScanTox (Denmark) and TRC Hungary)
     Laboratory of Pharmacology and Toxicology (Germany)
     Maccine (Singapore)
     MPI (USA)
     NOTOX (Netherlands)
     Quotient Bioresearch (UK)
     Ricerca (USA)
     Sequani (UK)
     TNO (Netherlands)
     WIL (USA)
     WuXi (China)