Biomedical Engineering Reference
In-Depth Information
Chow, S. and Liu, J. 2004. Design and Analysis of Clinical Trials . Wiley.
Crommelin, D. 2002. Pharmaceutical Biotechnology . Routledge.
De Jong, M. 1998. FAQs on EU Pharmaceutical Regulatory Affairs . Brookwood Medical Publications.
Desalli, R. 2002. The Genomics Revolution . Joseph Henry Press.
Everitt, B. and George, S. 2004. Textbook of Clinical Trials . Wiley.
Ferraiolo, B. 1992. Protein Pharmacokinetics and Metabolism . Plenum Publishers.
Goldberg, R. 2001. Pharmaceutical Medicine, Biotechnology and European Patent Law . Cambridge University
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Grindley, J. and Ogden, J. 2000. Understanding Biopharmaceuticals. Manufacturing and regulatory Issues .
Interpharm Press.
Knight, H. 2001. Patent Strategy . Wiley.
Krogsgaard, L. 2002. Textbook of Drug Design and Discovery . Taylor and Francis.
McNally, E. (ed.). 2000. Protein Formulation and Delivery . Marcel Dekker.
Oxender, D. and Post, L. 1999. Novel Therapeutics from Modern Biotechnology . Springer Verlag.
Pennington, S. 2000. Proteomics . BIOS Scientifi c Publishers.
Pisano, D. and Mantus, D. 2003. FDA Regulatory Affairs, a Guide for prescription Drugs, Medical Devices and
Biologics . CRC Press.
Poste, G. 1999. The Impact of Genomics on Healthcare . Royal Society of Medicine Press.
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Articles and websites
Clinical trials, development and regulatory
Chirino, A.J., Ary, M.L., and Marshall, S.A. 2004. Minimizing the immunogenicity of protein therapeutics.
Drug Discovery Today 9 , 82-90.
European Medicines Agency Website: http://www.emea.eu.int.
FDA Website: http://www.fda.gov.
Graffeo, A. 1994. The do's and don'ts of preclinical development. Bio/Technology 12 , 865.
Helms, P. 2002. Real world pragmatic clinical trials: what are they and what do they tell us? Pediatric Allergy
and Immunology 13 (1), 4 -9.
Hermeling, S., Crommelin, D.J.A., Schellekens, H., and Jiskoot, W. 2004. Structure-immunogenicity relation-
ships of therapeutic proteins. Pharmaceutical research, 21 , 897-903.
Jefferys, D. and Jones, K. 1995. EMEA and the new pharmaceutical procedures for Europe. European Journal
of Clinical Pharmacology 47 , 471-476.
Lubiniecki, A. 1997. Potential infl uence of international harmonization of pharmaceutical regulations on biop-
harmaceutical development. Current Opinion in Biotechnology 8 (3), 350-356.
Mahmood, I. and Green, M. 2005. Pharmacokinetic and pharmacodynamic considerations in the development of
therapeutic proteins. Clinical Pharmacokinetics 44 (4), 331-347.
Pignatti, F., Aronsson, B., Vamvakas, S., Wade, G., Papadouli, I., Papaluca, M., Moulon, I., and Courtois, P.L.
2002. Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology. Critical
Reviews in Oncology Haematology 42 (2), 123-135.
Schwardt, O., Kolb, H., and Ernst, B. 2003. Drug discovery today. Current Topics in Medicinal Chemistry 3 (1),
1-9.
Shankar, G., Shores, E., Wagner, C., and Mire-Sluis, A. 2006. Scientifi c and regulatory considerations on the
immunogenicity of biologics. Trends in Biotechnology 24 , 274-280.
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