Professional Documents
Culture Documents
References
Bear, Sterns & Co (2001). An assessment of the contract research marketplace to 2005.
In: PAREXELs Pharmaceutical R&D Statistical Sourcebook 2002.
Belbin, MR (1981). Management Teams Why they succeed or fail. Butterworth
Heinemann www.belbin.com/meredith.html
CMR International. www.cmr.org
Credit Suisse First Boston Health Care Research Group (2002). Measuring the contract
research organization market opportunity. In: PAREXELs Pharmaceutical R&D
Statistical Sourcebook 2002.
EMEA, CPMP/ICH/286/95 modification; Note for Guidance on Non-Clinical Safety
Studies for the Conduct of Human Clinical Trials for Pharmaceuticals.
EMEA, CPMP/ICH/539/00; Note for Guidance on Safety Pharmacology Studies for
Human Pharmaceuticals.
EMEA, CPMP/ICH/174/95; Note for Guidance on Genotoxicity: A Standard Battery for
Genotoxicity Testing of Pharmaceuticals.
EMEA, CPMP/ICH/386/95: Note for Guidance on Reproductive Toxicology: Detection
of Toxicity to Reproduction for Medicinal Products.
EMEA, CPMP/ICH/140/95; Note for Guidance on the need for Carcinogenicity Studies
of Pharmaceuticals.
EMEA, CPMP/ICH/299/95; Note for Guidance on Carcinogenicity: Testing for
Carcinogenicity of Pharmaceuticals.
Eudralex (1998). The Rules Governing Medicinal Products in the European Union
European Commission, Brussels.
Food and Drug Administration www.fda.gov/
Hughes, G and ONeill, M (2002). Annual review of contract research organisations. In:
European Pharmaceutical Contractor, Spring 2002, 1627.
ICH Guideline (1996). Topic E6: Good Clinical Practice Consolidated Guideline.
International Federation of Pharmaceutical Manufacturers Associations, Geneva.
Jones, D (1999) Blinded feedback on cerivastatin mock costing. Personal
communication.
Kermani, F and Findlay, G (2002). Understanding recent trends in pharmaceutical R&D.
In: European Pharmaceutical Contractor, Spring 2002, 2830.
The Malcolm Baldrige National Quality Improvement Act of Public Law 100107.
National Institute of Standards and Technology. www.nist.gov/
Nightingale, G (1989) Nightingales. Burson Marsteller.
Pharmaceutical Research and Manufacturers of America. www.phrmafoundation.org
PharmaNet: www.pharmanet.com
Scrips Pharmaceutical R&D Databook: Benchmarks, Trends and Analysis (2002). PJB
Publications.
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