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References Bear, Sterns & Co (2001). An assessment of the contract research marketplace to 2005. In: PAREXEL’s 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: PAREXEL’s 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 O’Neill, M (2002). Annual review of contract research organisations. In: European Pharmaceutical Contractor, Spring 2002, 16–27. 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, 28–30. The Malcolm Baldrige National Quality Improvement Act of Public Law 100–107. National Institute of Standards and Technology. www.nist.gov/ Nightingale, G (1989) Nightingale’s. Burson Marsteller. Pharmaceutical Research and Manufacturers of America. www.phrmafoundation.org PharmaNet: www.pharmanet.com Scrip’s Pharmaceutical R&D Databook: Benchmarks, Trends and Analysis (2002). PJB Publications. 101 © 2004 by CRC Press LLC

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Page 1: PH2084_REF

References

Bear, Sterns & Co (2001). An assessment of the contract research marketplace to 2005.In: PAREXEL’s Pharmaceutical R&D Statistical Sourcebook 2002.

Belbin, MR (1981). Management Teams – Why they succeed or fail. ButterworthHeinemann www.belbin.com/meredith.html

CMR International. www.cmr.orgCredit Suisse First Boston Health Care Research Group (2002). Measuring the contract

research organization market opportunity. In: PAREXEL’s Pharmaceutical R&DStatistical Sourcebook 2002.

EMEA, CPMP/ICH/286/95 modification; Note for Guidance on Non-Clinical SafetyStudies for the Conduct of Human Clinical Trials for Pharmaceuticals.

EMEA, CPMP/ICH/539/00; Note for Guidance on Safety Pharmacology Studies forHuman Pharmaceuticals.

EMEA, CPMP/ICH/174/95; Note for Guidance on Genotoxicity: A Standard Battery forGenotoxicity Testing of Pharmaceuticals.

EMEA, CPMP/ICH/386/95: Note for Guidance on Reproductive Toxicology: Detectionof Toxicity to Reproduction for Medicinal Products.

EMEA, CPMP/ICH/140/95; Note for Guidance on the need for Carcinogenicity Studiesof Pharmaceuticals.

EMEA, CPMP/ICH/299/95; Note for Guidance on Carcinogenicity: Testing forCarcinogenicity of Pharmaceuticals.

Eudralex (1998). The Rules Governing Medicinal Products in the European UnionEuropean Commission, Brussels.

Food and Drug Administration www.fda.gov/Hughes, G and O’Neill, M (2002). Annual review of contract research organisations. In:

European Pharmaceutical Contractor, Spring 2002, 16–27.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, 28–30.The Malcolm Baldrige National Quality Improvement Act of Public Law 100–107.

National Institute of Standards and Technology. www.nist.gov/Nightingale, G (1989) Nightingale’s. Burson Marsteller.Pharmaceutical Research and Manufacturers of America. www.phrmafoundation.orgPharmaNet: www.pharmanet.comScrip’s Pharmaceutical R&D Databook: Benchmarks, Trends and Analysis (2002). PJB

Publications.

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References 7/11/03 12:09 pm Page 101

© 2004 by CRC Press LLC

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Technomark Consulting Services: www.technomark.comTufts Center for the Study of Drug Development. www.tufts.edu/med/csddUS Government Printing Office (1949). Nuremberg Code: Trials of war criminals before

the Nuremberg Military Tribunals under Control Council Law No 10, Vol 2,181–182, Washington DC.

Windley, D (1999). Contract Research Organizations, The Outsourcing Advantage. JCBradford & Co Report.

World Medical Association (2000). Declaration of Helsinki: Ethical Principles forMedical Research Involving Human Subjects. www.wma.net/e/policyb3.html

102 Clinical Studies Management: A Practical Guide to Success

References 7/11/03 12:09 pm Page 102

© 2004 by CRC Press LLC