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Toxicology and Pharmacology
Biopharm Knowledge Publishing, Jan 2010, Pages: 150
Toxicology and Pharmacology: Outsourcing, History, Process and Regulation; Technical, Political and Economic Challenges
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
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.
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