21st Century Drug Development: Advances,Opportunities and Challenges

FDA (2004). Introduction or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. Silver Spring, MD, USA: US Department of Health and Human Services, Food and Drug Administration. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm (Accessed 26.08.09).

Thomas J. , Moore A.B. , Michael R. , Cohen R. , Curt D. & Furberg M.D. (2007). Serious adverse drug events reported to the Food and Drug Administration, 1998–2005. Archives of Internal Medicine 167, 1752–1759.

Fung M. , Thornton A. , Mybeck K. , Wu J.H-H. , Hornbuckle K. & Muniz E. (2001). Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets — 1960 to 1999. Drug Information Journal 35, 293–317.

Kola I. & Landis J. (2004). Can the pharmaceutical industry reduce attrition rates? Nature Reviews. Drug Discovery 3, 711–715.

Walker I. & Newell H. (2009). Do molecularly targeted agents in oncology have reduced attrition rates? Nature Reviews. Drug Discovery 8, 15–16.

Pereira S.P. , Pereira G.C. , Moreno A.J. & Oliveira P.J. (2009). Can drug safety be predicted and animal experiments reduced by using isolated mitichondrial fractions? ATLA 37, 355–365.

Greaves P. , Williams A. & Eve M. (2004). First dose of potential new medicines to humans: How animals help. Nature Reviews. Drug Discovery 3, 226–236.

Smith R.A. (2009). Twenty-first century challenges for in vitro neurotoxicity. ATLA 37, 367–375.

Li A.P. (2009). The use of the Integrated Discrete Multiple Organ Co-culture (IdMOC^®) system for the evaluation of multiple organ toxicity. ATLA 37, 377–385.

Overington J.P. , Al-Lazikani B. & Hopkins A.L. (2006). How many drug targets are there? Nature Reviews. Drug Discovery 5, 993–996.

Lawrence S. (2005). Biotech drug market steadily expands. Nature Biotechnology 23, 1466.

Corsini E. & Roggen E.L. (2009). Immunotoxicology: Opportunities for non-animal test development. ATLA 37, 387–397.

Giese C. , Demmler C.D. , Ammer R. , Haartmann S. , Lubitz A. , Miller L. , Muller R. & Marx U. (2006). A human lymph node in vitro — challenges and progress. Artificial Organs 10, 803–808.

Gaucher D. , Therrien R. , Kettaf N. , Angermann B.R. , Boucher G. , Filali-Mouhim A. , Moser J.M. , Mehta R.S. , Drake D.R. III , Castro E. , Akondy R. , Rinfret A. , Yassine-Diab B. , Said E.A. , Chouikh Y. , Cameron M.J. , Clum R. , Kelvin D. , Somogyi R. , Greller L.D. , Balderas R.S. , Wilkinson P. , Pantaleo G. , Tartaglia J. , Haddad E.K. & Sékaly R-P. (2008). Yellow fever vaccine induces integrated multilineage and polyfunctional immune responses. Journal of Experimental Medicine 205, 3119–3131.