Clinical development of therapeutic recombinant proteins.
作者： Janice M. Reichert , Cherie Paquette
DOI: 10.2144/03351DD01
关键词:
摘要: Only a small subset of the therapeutics that enter clinical studies will prove to be safe and effective in humans gain approval for marketing. The success products and, by inference, sponsoring companies can measured tracking advancement through phase review transitions marketing approval. To determine transition probabilities rates recombinant protein (rDNA) therapeutics, Tufts Center Study Drug Development collected data 271 rDNA entered study between 1980 2002. were stratified into eight therapeutic categories. Approval calculated with two possible fates: (i) any country (ii) U.S. only. Global ranged from 23% 63%, 17% 58%. Trends lengths over five time periods an overview currently under Food Administration are discussed.
future-science.com
unirioja.es
biotechniques.com 参考文章(10)
Janice M. Reichert, Monoclonal antibodies in the clinic. Nature Biotechnology. ,vol. 19, pp. 819- 822 ,(2001) , 10.1038/NBT0901-819
Christopher-Paul Milne, Orphan products--pain relief for clinical development headaches. Nature Biotechnology. ,vol. 20, pp. 780- 784 ,(2002) , 10.1038/NBT0802-780
Hamish S. Scott, Susanna Bunge, Andreas Gal, Lome A. Clarke, C. Phillip Morris, John J. Hopwood, Molecular genetics of muccpolysaccharidosis type I: Diagnostic, clinical, and biological implications Human Mutation. ,vol. 6, pp. 288- 302 ,(1995) , 10.1002/HUMU.1380060403
Raphael Schiffmann, Jeffrey B. Kopp, Howard A. Austin III, Sharda Sabnis, David F. Moore, Thais Weibel, James E. Balow, Roscoe O. Brady, Enzyme replacement therapy in Fabry disease: a randomized controlled trial. JAMA. ,vol. 285, pp. 2743- 2749 ,(2001) , 10.1001/JAMA.285.21.2743
J DiMasi, Risks in new drug development: approval success rates for investigational drugs. Clinical Pharmacology & Therapeutics. ,vol. 69, pp. 297- 307 ,(2001) , 10.1067/MCP.2001.115446
Janice M. Reichert, CLINICAL DEVELOPMENT OF THERAPEUTIC MEDICINES: A BIOPHARMACEUTICAL VERSUS PHARMACEUTICAL PRODUCT COMPARISON Drug Information Journal. ,vol. 35, pp. 337- 346 ,(2001) , 10.1177/009286150103500203
K. Hermansen, S. Madsbad, H. Perrild, A. Kristensen, M. Axelsen, Comparison of the Soluble Basal Insulin Analog Insulin Detemir With NPH Insulin: A randomized open crossover trial in type 1 diabetic subjects on basal-bolus therapy Diabetes Care. ,vol. 24, pp. 296- 301 ,(2001) , 10.2337/DIACARE.24.2.296
Emil D. Kakkis, Joseph Muenzer, George E. Tiller, Lewis Waber, John Belmont, Merry Passage, Barbara Izykowski, Jeffrey Phillips, Robin Doroshow, Irv Walot, Richard Hoft, Kian Ti Yu, Susie Okazaki, Dave Lewis, Ralph Lachman, Jerry N. Thompson, Elizabeth F. Neufeld, Enzyme-replacement therapy in mucopolysaccharidosis I. The New England Journal of Medicine. ,vol. 344, pp. 182- 188 ,(2001) , 10.1056/NEJM200101183440304
Christine M. Eng, Nathalie Guffon, William R. Wilcox, Dominique P. Germain, Philip Lee, Steve Waldek, Louis Caplan, Gabor E. Linthorst, Robert J. Desnick, Safety and efficacy of recombinant human alpha-galactosidase A replacement therapy in Fabry's disease. The New England Journal of Medicine. ,vol. 345, pp. 9- 16 ,(2001) , 10.1056/NEJM200107053450102
M. E Ng, S Teve W Aldek, N Athalie G Uffon, P Hilip L Ee, W Illiam R. W Ilcox, R Obert J. D Esnick, E. L Inthorst, P. G Ermain, L Ouis C Aplan, SAFETY AND EFFICACY OF RECOMBINANT HUMAN a -GALACTOSIDASE A REPLACEMENT THERAPY IN FABRY'S DISEASE ,(2001)