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:

FDA Website:

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 relationships 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 influence 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. Scientific and regulatory considerations on the immunogenicity of biologics. Trends in Biotechnology 24, 274-280.

Streatfield, S. 2005. Regulatory issues for plant-made pharmaceuticals and vaccines. Expert Review of Vaccines 4(4), 591-601.

Tang, L., Persky, A.M., Hochhaus, G., and Meibohm, B. 2004. Pharmacokinetic aspects of biotechnology products. Journal of Pharmaceutical Sciences 93(9), 2184-2204. Walsh, G. 1999. Drug approval in Europe. Nature Biotechnology, 17, 237-240.

Walsh, G. 2006. Drug approval in the European Union and United States. In An Introduction to Molecular Biotechnology, Wink, M. (ed.). Wiley-VCH; pp. 651-662.

Drug delivery

Davis, S. 2001. Nasal vaccines. Advanced Drug Delivery Reviews 51, 21-42.

Hamman, J.H., Enslin, G.M., and Kotze, A.F. 2005. Oral delivery of peptide drugs - barriers and developments. Biodrugs 19(3), 165-177.

Kompella, U.B. and Lee, V.H.L. 2001. Delivery systems for penetration enhancement of peptide and protein drugs: design considerations. Advanced Drug Delivery Reviews 46, 211-245.

Hussain, A., Arnold, J.J., Khan, M.A., and Ahsan, F. 2004. Absorption enhancers in pulmonary drug delivery. Journal of Controlled Release 94(1), 15-24.

Orive, G., Hernandez, R.M., Gascon, A.R., Dominguez-Gil, A., and Pedraz, J.L. 2003. Drug delivery in biotechnology: present and future. Current Opinion in Biotechnology 14(6), 659-664.

Patton, J. 1996. Mechanisms of macromolecule absorption by the lungs. Advanced Drug Delivery Reviews 19, 3-36.

Patton, J.S., Bukar, J.G., and Eldon, M.A. 2004. Clinical pharmacokinetics and pharmacodynamics of inhaled insulin. Clinical Pharmacokinetics 43(12), 781-801.

Quattrin, T. 2004. Inhaled insulin: recent advances in the therapy of type 1 and 2 diabetes. Expert Opinion on Pharmacotherapy. 5(12), 2597-2604.

Shah, R.B., Ahsan, F., and Khan, M.A. 2002. Oral delivery of proteins: progress and prognostication. Critical Reviews in Therapeutic Drug Carrier Systems 19(2), 135-169.

Shaikh, I.M., Jadhav, K.R., Ganga, S., Kadam, V.J., and Pisal, S.S. 2005. Advanced approaches in insulin delivery. Current Pharmaceutical Biotechnology 6(5), 387-395.

Veronese, F.M. and Pasut, G. 2005. PEGylation, successful approach to drug delivery. Drug Discovery Today 10, 1451-1458.

Genomics, proteomics and related technologies

Baba, Y. 2001. Development of novel biomedicine based on genome science. European Journal of Pharmaceutical Sciences 13(1), 3-4.

Brenner, S. 2001. A tour of structural genomics. Nature Reviews Genetics 2(10), 801-809.

Cunningham, M. 2000. Genomics and proteomics, the new millennium of drug discovery and development. Journal of Pharmacological and Toxicological Methods 44(1), 291-300.

Debouck, C. and Goodfellow, P. 1999. DNA microarrays in drug discovery and development. Nature Genetics 21, 48-50.

Gabig, M. and Wegrzyn, G. 2001. An introduction to DNA chips: principles, technology, applications and analysis. Acta Biochimica Polonica 48(3), 615-622.

Jain, K. 2001. Proteomics: new technologies and their applications. Drug Discovery Today 6(9), 457-459.

Jain, K. 2001. Proteomics: delivering new routes to drug discovery, part 2. Drug Discovery Today. 6(16), 829-832.

Kassel, D. 2001. Combinatorial chemistry and mass spectrometry in the 21st century drug development laboratory. Chemical Reviews 101(2), 255-267.

Lesley, S. 2001. High-throughput proteomics: protein expression and purification in the post-genomic world. Protein Expression and Purification 22(2), 159-164.

McLeod, H. and Evans, W. 2001. Pharmacogenomics: unlocking the human genome for better drug therapy. Annual Review of Pharmacology and Toxicology 41, 101-121.

Page, M.J., Amess, B., Rohlff, C., Stubberfield, C., and Parekh, R. 1999. Proteomics: a major new technology for the drug discovery process. Drug Discovery Today 4(2), 55-62.

Ramsay, G. 1998. DNA chips: state of the art. Nature Biotechnology 16(1), 40-44.

Roses, A. 2000. Pharmacogenetics and the practice of medicine. Nature. 405, (6788), 857-865.

Schmitz, G., Aslanidis, C., and Lackner, K.J. 2001. Pharmacogenomics: implications for laboratory medicine. Clinica Chemica Acta 308(1-2), 43-53.

Searls, D. 2000. Using bioinformatics in gene and drug discovery. Drug Discovery Today 5(4), 135-143.

Terstappen, G. and Reggiani, A. 2001. In silico research in drug discovery. Trends in Pharmacological Sciences 22(1), 23-26.

Wamg, J. and Hewick, R. 1999. Proteomics in drug discovery. Drug Discovery Today 4(3), 129-133.

Wieczorek, S. and Tsongalis, G. 2001. Pharmacogenomics: will it change the field of medicine? Clinica Chimica Acta 308(1-2), 1-8.

Wilgenbus, K. and Lichter, P. 1999. DNA chip technology ante portas. Journal of Molecular Medicine 77(11), 761-768.

Wolf, C.R., Smith, G., and Smith, R.I. 2000. Science, medicine and the future - pharmacogenetics. British Medical Journal 320(7240), 987-990.


Allison, J. and Lemley, M. 2002. The growing complexity of the United States patenting system. Boston University Law Review 82(1), 77-144. Barton, J. 1991. Patenting life. Scientific American (March), 18-24.

Berks, A. 1994. Patent information in biotechnology. Trends in Biotechnology 12, 352-364.

Farnley, S., Morey-Nase, P., and Sternfeld, D. 2004. Biotechnology - a challenge to the patent system. Current

Opinion in Biotechnology 15(3), 254-257. Johnson, E. 1996. A benchside guide to patents and patenting. Nature Biotechnology 14, 288-291. Orr, R. and O'Neill, C. 2000. Patent review: therapeutic applications of antisense oligonucleotides, 1999-2000.

Current Opinion in Molecular Therapeutics 2(3), 325-331. Schellekens, H. 2004. When biotech products go off patent. Trends in Biotechnology 22(8), 406-410. Yeh, J., and Fernandez, D. 2004. Patent protection strategies for biotechnological inventions. Assay and Drug Development Technologies 2(6), 697-702.

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