-
2
-
-
3843149585
-
Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans
-
Bugelski, P.J. & Treacy, G. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. Curr. Opin. Mol. Ther. 6, 10-16 (2004).
-
(2004)
Curr. Opin. Mol. Ther
, vol.6
, pp. 10-16
-
-
Bugelski, P.J.1
Treacy, G.2
-
3
-
-
0035793375
-
Immunogenicity of biopharmaceuticals in laboratory animals
-
Wierda, D., Smith, H.W. & Zwickl, C.M. Immunogenicity of biopharmaceuticals in laboratory animals. Toxicology 158, 71-74 (2001).
-
(2001)
Toxicology
, vol.158
, pp. 71-74
-
-
Wierda, D.1
Smith, H.W.2
Zwickl, C.M.3
-
4
-
-
80053352042
-
Translational research: 4 ways to fix the clinical trial
-
Ledford, H. Translational research: 4 ways to fix the clinical trial. Nature 477, 526-528 (2011).
-
(2011)
Nature
, vol.477
, pp. 526-528
-
-
Ledford, H.1
-
5
-
-
83655197118
-
Microdosing studies using accelerated mass spectrometry as exploratory investigational new drug trials
-
Bae, S.K. & Shon, J.H. Microdosing studies using accelerated mass spectrometry as exploratory investigational new drug trials. Arch. Pharm. Res. 34, 1789-1798 (2011).
-
(2011)
Arch. Pharm. Res
, vol.34
, pp. 1789-1798
-
-
Bae, S.K.1
Shon, J.H.2
-
7
-
-
33748167008
-
Use of microdosing to predict pharmacokinetics at the therapeutic dose: Experience with 5 drugs
-
Lappin, G., et al. Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs. Clin. Pharmacol. Ther. 80, 203-215 (2006).
-
(2006)
Clin. Pharmacol. Ther
, vol.80
, pp. 203-215
-
-
Lappin, G.1
-
8
-
-
78649237052
-
Human microdosing for the prediction of patient response
-
Henderson, P.T. & Pan, C.X. Human microdosing for the prediction of patient response. Bioanalysis 2, 373-376 (2010).
-
(2010)
Bioanalysis
, vol.2
, pp. 373-376
-
-
Henderson, P.T.1
Pan, C.X.2
-
11
-
-
33644827201
-
-
U.S. Department of Health and Human Services Food and Drug Administration
-
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for industry, investigators, and reviewers. (2006).
-
(2006)
Guidance for Industry, Investigators, and Reviewers
-
-
-
14
-
-
43949136451
-
Subattomole sensitivity in biological accelerator mass spectrometry
-
Salehpour, M., Possnert, G. & Bryhni, H. Subattomole sensitivity in biological accelerator mass spectrometry. Anal. Chem. 80, 3515-3521 (2008).
-
(2008)
Anal. Chem
, vol.80
, pp. 3515-3521
-
-
Salehpour, M.1
Possnert, G.2
Bryhni, H.3
-
15
-
-
0034935772
-
Attomole quantitation of protein separations with accelerator mass spectrometry
-
Vogel, J.S., Grant, P.G., Buchholz, B.A., Dingley, K. & Turteltaub, K.W. Attomole quantitation of protein separations with accelerator mass spectrometry. Electrophoresis 22, 2037-2045 (2001).
-
(2001)
Electrophoresis
, vol.22
, pp. 2037-2045
-
-
Vogel, J.S.1
Grant, P.G.2
Buchholz, B.A.3
Dingley, K.4
Turteltaub, K.W.5
-
16
-
-
84905717230
-
Automated combustion accelerator mass spectrometry for the analysis of biomedical samples in the low attomole range
-
Van Duijn, E., Sandman, H., Grossouw, D., Mocking, J.A., Coulier, L. & Vaes, W.H. Automated combustion accelerator mass spectrometry for the analysis of biomedical samples in the low attomole range. Anal. Chem. 86, 7635-7641 (2014).
-
(2014)
Anal. Chem
, vol.86
, pp. 7635-7641
-
-
Van Duijn, E.1
Sandman, H.2
Grossouw, D.3
Mocking, J.A.4
Coulier, L.5
Vaes, W.H.6
-
17
-
-
60349087476
-
Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies
-
Muller, P.Y. & Brennan, F.R. Safety assessment and dose selection for first-in-human clinical trials with immunomodulatory monoclonal antibodies. Clin. Pharmacol. Ther. 85, 247-258 (2009).
-
(2009)
Clin. Pharmacol. Ther
, vol.85
, pp. 247-258
-
-
Muller, P.Y.1
Brennan, F.R.2
-
18
-
-
0027991788
-
Phosphodiesterase activity is a novel property of alkaline phosphatase from osseous plate
-
Rezende, A.A., Pizauro, J.M., Ciancaglini, P. & Leone, F.A. Phosphodiesterase activity is a novel property of alkaline phosphatase from osseous plate. Biochem. J. 301 (Pt 2), 517-522 (1994).
-
(1994)
Biochem. J.
, vol.301
, pp. 517-522
-
-
Rezende, A.A.1
Pizauro, J.M.2
Ciancaglini, P.3
Leone, F.A.4
-
19
-
-
0030970524
-
A physiologic function for alkaline phosphatase: Endotoxin detoxification
-
Poelstra, K., Bakker, W.W., Klok, P.A., Hardonk, M.J. & Meijer, D.K. A physiologic function for alkaline phosphatase: endotoxin detoxification. Lab. Invest. 76, 319-327 (1997).
-
(1997)
Lab. Invest
, vol.76
, pp. 319-327
-
-
Poelstra, K.1
Bakker, W.W.2
Klok, P.A.3
Hardonk, M.J.4
Meijer, D.K.5
-
20
-
-
84862739897
-
Prophylactic treatment with alkaline phosphatase in cardiac surgery induces endogenous alkaline phosphatase release
-
Kats, S., et al. Prophylactic treatment with alkaline phosphatase in cardiac surgery induces endogenous alkaline phosphatase release. Int. J. Artif. Organs 35, 144-151 (2012).
-
(2012)
Int. J. Artif. Organs
, vol.35
, pp. 144-151
-
-
Kats, S.1
-
21
-
-
70350760065
-
Anti-inflammatory effects of alkaline phosphatase in coronary artery bypass surgery with cardiopulmonary bypass
-
Kats, S., et al. Anti-inflammatory effects of alkaline phosphatase in coronary artery bypass surgery with cardiopulmonary bypass. Recent Pat. Inflamm. Allergy Drug Discov. 3, 214-220 (2009).
-
(2009)
Recent Pat. Inflamm. Allergy Drug Discov
, vol.3
, pp. 214-220
-
-
Kats, S.1
-
22
-
-
0142179149
-
Calf intestinal alkaline phosphatase, a novel therapeutic drug for lipopolysaccharide (LPS)-mediated diseases, attenuates LPS toxicity in mice and piglets
-
Beumer, C., Wulferink. M., Raaben, W., Fiechter, D., Brands, R. & Seinen, W. Calf intestinal alkaline phosphatase, a novel therapeutic drug for lipopolysaccharide (LPS)-mediated diseases, attenuates LPS toxicity in mice and piglets. J. Pharmacol. Exp. Ther. 307, 737-744 (2003).
-
(2003)
J. Pharmacol. Exp. Ther
, vol.307
, pp. 737-744
-
-
Beumer, C.1
Wulferink, M.2
Raaben, W.3
Fiechter, D.4
Brands, R.5
Seinen, W.6
-
24
-
-
79956356127
-
Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers
-
Lappin, G., et al. Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers. Eur. J. Pharm. Sci. 43, 141-150 (2011).
-
(2011)
Eur. J. Pharm. Sci
, vol.43
, pp. 141-150
-
-
Lappin, G.1
-
25
-
-
77951918031
-
Accelerator mass spectrometry offers new opportunities for microdosing of peptide and protein pharmaceuticals
-
Salehpour, M., Ekblom, J., Sabetsky, V., Håkansson, K. & Possnert, G. Accelerator mass spectrometry offers new opportunities for microdosing of peptide and protein pharmaceuticals. Rapid Commun. Mass Spectrom. 24, 1481-1489 (2010).
-
(2010)
Rapid Commun. Mass Spectrom
, vol.24
, pp. 1481-1489
-
-
Salehpour, M.1
Ekblom, J.2
Sabetsky, V.3
Håkansson, K.4
Possnert, G.5
-
26
-
-
84871544301
-
Iodine-129 microdosing for protein and peptide drug development: Erythropoietin as a case study
-
Lamers, R.J., De Jong, A.F., L-opez-Guti-errez, J.M. & G-omez-Guzm-An, J. Iodine-129 microdosing for protein and peptide drug development: erythropoietin as a case study. Bioanalysis 5, 53-63 (2013).
-
(2013)
Bioanalysis
, vol.5
, pp. 53-63
-
-
Lamers, R.J.1
De Jong, A.F.2
L-opez-Guti-Errez, J.M.3
G-Omez-Guzm-An, J.4
-
27
-
-
79957782000
-
Impact of microdosing clinical study - Why necessary and how useful?
-
Sugiyama, Y. & Yamashita, S. Impact of microdosing clinical study - why necessary and how useful?. Adv. Drug Deliv. Rev. 63, 494-502 (2011).
-
(2011)
Adv. Drug Deliv. Rev
, vol.63
, pp. 494-502
-
-
Sugiyama, Y.1
Yamashita, S.2
-
28
-
-
84870927895
-
The 1 MV multi-element AMS system for biomedical applications at the Netherlands Organization for Applied Scientific Research (TNO)
-
Klein, M., Vaes, W.H.J., Fabriek, B., Sandman, H., Mous, D.J.W. & Gottdang, A. The 1 MV multi-element AMS system for biomedical applications at the Netherlands Organization for Applied Scientific Research (TNO). Nucl. Instrum. Methods Phys. Res. B. 294, 14-17 (2013).
-
(2013)
Nucl. Instrum. Methods Phys. Res. B.
, vol.294
, pp. 14-17
-
-
Klein, M.1
Vaes, W.H.J.2
Fabriek, B.3
Sandman, H.4
Mous, D.J.W.5
Gottdang, A.6
-
29
-
-
79952010877
-
Analytical validation of accelerator mass spectrometry for pharmaceutical development
-
Keck, B.D., Ognibene, T. & Vogel, J.S. Analytical validation of accelerator mass spectrometry for pharmaceutical development. Bioanalysis 2, 469-485 (2010).
-
(2010)
Bioanalysis
, vol.2
, pp. 469-485
-
-
Keck, B.D.1
Ognibene, T.2
Vogel, J.S.3
-
30
-
-
84870532212
-
European Bioanalysis Forum recommendation: Scientific validation of quantification by accelerator mass spectrometry
-
Higton, D., Young, G., Timmerman, P., Abbott, R., Knutsson, M. & Svensson, L.D. European Bioanalysis Forum recommendation: scientific validation of quantification by accelerator mass spectrometry. Bioanalysis 4, 2669-2679 (2012).
-
(2012)
Bioanalysis
, vol.4
, pp. 2669-2679
-
-
Higton, D.1
Young, G.2
Timmerman, P.3
Abbott, R.4
Knutsson, M.5
Svensson, L.D.6
-
32
-
-
78049289954
-
Is the consensus value of anu sucrose (IAEA C-6 too high?
-
Xu, X., Khosh, M.S., Druffel E.R.M., Trumbore, S.E. & Southon, J.R. Is the consensus value of anu sucrose (IAEA C-6) too high?. Radiocarbon 52, 866-874 (2010).
-
(2010)
Radiocarbon
, vol.52
, pp. 866-874
-
-
Xu, X.1
Khosh, M.S.2
Druffel, E.R.M.3
Trumbore, S.E.4
Southon, J.R.5
-
33
-
-
83855161149
-
NLME: Linear and nonlinear mixed effects models
-
The R Development Core Team
-
Pinheiro, J., Bates, D., DebRoy, S., Sarkar, D. & the R Development Core Team. NLME: Linear and nonlinear mixed effects models. R Foundation for Statistical Computing version 3.1-100 (2011).
-
(2011)
R Foundation for Statistical Computing Version 3.1-100
-
-
Pinheiro, J.1
Bates, D.2
DebRoy, S.3
Sarkar, D.4
|