-
1
-
-
79952459325
-
Overview of metabolite safety testing from an industry perspective
-
21083238 1:CAS:528:DC%2BC3cXptFWru74%3D 10.4155/bio.10.67
-
S. Anderson M. P. Knadler D. Luffer-Atlas 2010 Overview of metabolite safety testing from an industry perspective Bioanalysis 2 1249 1261 21083238 1:CAS:528:DC%2BC3cXptFWru74%3D 10.4155/bio.10.67
-
(2010)
Bioanalysis
, vol.2
, pp. 1249-1261
-
-
Anderson, S.1
Knadler, M.P.2
Luffer-Atlas, D.3
-
2
-
-
79952459611
-
Accelerator mass spectrometry-enabled studies: Current status and future prospects
-
20440378 1:CAS:528:DC%2BC3cXktFKqtLs%3D 10.4155/bio.09.188
-
A. Arjomand 2010 Accelerator mass spectrometry-enabled studies: current status and future prospects Bioanalysis 2 519 541 20440378 1:CAS:528: DC%2BC3cXktFKqtLs%3D 10.4155/bio.09.188
-
(2010)
Bioanalysis
, vol.2
, pp. 519-541
-
-
Arjomand, A.1
-
3
-
-
39749165005
-
Microdosing studies in humans: The role of positron emission tomography
-
DOI 10.2165/00126839-200809020-00002
-
M. Bauer C. C. Wagner O. Langer 2008 Microdosing studies in humans: the role of positron emission tomography Drugs R D 9 73 81 18298126 1:CAS:528:DC%2BD1cXktlyjtr0%3D 10.2165/00126839-200809020-00002 (Pubitemid 351311221)
-
(2008)
Drugs in R and D
, vol.9
, Issue.2
, pp. 73-81
-
-
Bauer, M.1
Wagner, C.C.2
Langer, O.3
-
4
-
-
30144437351
-
Accelerator mass spectrometry for biomedical research
-
DOI 10.1016/S0076-6879(05)02014-8, PII S0076687905020148, 14, Biological Mass Spectrometry
-
K. Brown K. H. Dingley K. W. Turteltaub 2005 Accelerator mass spectrometry for biomedical research Methods Enzymol. 402 423 443 16401518 1:CAS:528:DC%2BD28XosFeru70%3D 10.1016/S0076-6879(05)02014-8 (Pubitemid 43053135)
-
(2005)
Methods in Enzymology
, vol.402
, pp. 423-443
-
-
Brown, K.1
Dingley, K.H.2
Turteltaub, K.W.3
-
5
-
-
33644845444
-
Mass spectrometry and isotopes: A century of research and discussion
-
16134128 1:CAS:528:DC%2BD28Xht12gs7g%3D 10.1002/mas.20061
-
H. Budzikiewicz R. D. Grigsby 2006 Mass spectrometry and isotopes: a century of research and discussion Mass Spectrom. Rev. 25 146 157 16134128 1:CAS:528:DC%2BD28Xht12gs7g%3D 10.1002/mas.20061
-
(2006)
Mass Spectrom. Rev.
, vol.25
, pp. 146-157
-
-
Budzikiewicz, H.1
Grigsby, R.D.2
-
6
-
-
34047127580
-
The drug development crisis: Efficiency and safety
-
DOI 10.1146/annurev.med.58.042705.124037
-
C. T. Caskey 2007 The drug development crisis: efficiency and safety Annu. Rev. Med. 58 1 16 17059362 1:CAS:528:DC%2BD2sXisV2jsLo%3D 10.1146/annurev.med.58.042705.124037 (Pubitemid 46706497)
-
(2007)
Annual Review of Medicine
, vol.58
, pp. 1-16
-
-
Caskey, C.T.1
-
7
-
-
0037406978
-
Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing
-
DOI 10.1016/S0928-0987(03)00040-X
-
R. D. Combes T. Berridge J. Connelly M. D. Eve R. C. Garner S. Toon P. Wilcox 2003 Early microdose drug studies in human volunteers can minimise animal testing: Proceedings of a workshop organised by Volunteers in Research and Testing Eur. J. Pharm. Sci. 19 1 11 12729856 1:CAS:528:DC%2BD3sXjt1Ogsrw%3D 10.1016/S0928-0987(03)00040-X (Pubitemid 36506932)
-
(2003)
European Journal of Pharmaceutical Sciences
, vol.19
, Issue.1
, pp. 1-11
-
-
Combes, R.D.1
Berridge, T.2
Connelly, J.3
Eve, M.D.4
Garner, R.C.5
Toon, S.6
Wilcox, P.7
-
8
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DOI 10.1016/S0167-6296(02)00126-1
-
J. A. DiMasi R. W. Hansen H. G. Grabowski 2003 The price of innovation: new estimates of drug development costs J. Health Econ. 22 151 185 12606142 10.1016/S0167-6296(02)00126-1 (Pubitemid 36279392)
-
(2003)
Journal of Health Economics
, vol.22
, Issue.2
, pp. 151-185
-
-
DiMasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
11
-
-
68149139355
-
Recent advances in biomedical applications of accelerator mass spectrometry
-
19534792 10.1186/1423-0127-16-54
-
S. S. Hah P. T. Henderson K. W. Turteltaub 2009 Recent advances in biomedical applications of accelerator mass spectrometry J. Biomed. Sci. 16 54 19534792 10.1186/1423-0127-16-54
-
(2009)
J. Biomed. Sci.
, vol.16
, pp. 54
-
-
Hah, S.S.1
Henderson, P.T.2
Turteltaub, K.W.3
-
12
-
-
54349090949
-
Biological/biomedical accelerator mass spectrometry targets. 1. optimizing the CO2 reduction step using zinc dust
-
18785761 1:CAS:528:DC%2BD1cXhtFSrsrjM 10.1021/ac801226g
-
S. H. Kim P. B. Kelly A. J. Clifford 2008 Biological/biomedical accelerator mass spectrometry targets. 1. optimizing the CO2 reduction step using zinc dust Anal. Chem. 80 7651 7660 18785761 1:CAS:528:DC%2BD1cXhtFSrsrjM 10.1021/ac801226g
-
(2008)
Anal. Chem.
, vol.80
, pp. 7651-7660
-
-
Kim, S.H.1
Kelly, P.B.2
Clifford, A.J.3
-
14
-
-
36849015815
-
Ethics at phase 0: Clarifying the issues
-
18076522 10.1111/j.1748-720X.2007.00194.x
-
J. Kimmelman 2007 Ethics at phase 0: clarifying the issues J. Law Med. Ethics 35 727 733 18076522 10.1111/j.1748-720X.2007.00194.x
-
(2007)
J. Law Med. Ethics
, vol.35
, pp. 727-733
-
-
Kimmelman, J.1
-
15
-
-
0037365932
-
Big physics, small doses: The use of AMS and PET in human microdosing of development drugs
-
DOI 10.1038/nrd1037
-
G. Lappin R. C. Garner 2003 Big physics, small doses: the use of AMS and PET in human microdosing of development drugs Nat. Rev. Drug Discov. 2 233 240 12612650 1:CAS:528:DC%2BD3sXhsFKrtLc%3D 10.1038/nrd1037 (Pubitemid 37361669)
-
(2003)
Nature Reviews Drug Discovery
, vol.2
, Issue.3
, pp. 233-240
-
-
Lappin, G.1
Garner, R.C.2
-
16
-
-
33748361948
-
The use of accelerator mass spectrometry to obtain early human ADME/PK data
-
16922650 1:CAS:528:DC%2BD2MXmvVGhs74%3D 10.1517/17425255.1.1.23
-
G. Lappin R. C. Garner 2005 The use of accelerator mass spectrometry to obtain early human ADME/PK data Expert Opin. Drug Metab. Toxicol. 1 23 31 16922650 1:CAS:528:DC%2BD2MXmvVGhs74%3D 10.1517/17425255.1.1.23
-
(2005)
Expert Opin. Drug Metab. Toxicol.
, vol.1
, pp. 23-31
-
-
Lappin, G.1
Garner, R.C.2
-
17
-
-
33748167008
-
Use of microdosing to predict pharmacokinetics at the therapeutic dose: Experience with 5 drugs
-
DOI 10.1016/j.clpt.2006.05.008, PII S0009923606002001
-
G. Lappin W. Kuhnz R. Jochemsen J. Kneer A. Chaudhary B. Oosterhuis W. J. Drijfhout M. Rowland R. C. Garner 2006 Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs Clin. Pharmacol. Ther. 80 203 215 16952487 1:CAS:528:DC%2BD28XptFCgu7w%3D 10.1016/j.clpt.2006.05.008 (Pubitemid 44313903)
-
(2006)
Clinical Pharmacology and Therapeutics
, vol.80
, Issue.3
, pp. 203-215
-
-
Lappin, G.1
Kuhnz, W.2
Jochemsen, R.3
Kneer, J.4
Chaudhary, A.5
Oosterhuis, B.6
Drijfhout, W.J.7
Rowland, M.8
Garner, R.C.9
-
18
-
-
58149188094
-
The utility of microdosing over the past 5 years
-
19040326 1:CAS:528:DC%2BD1cXhsVent7zN 10.1517/17425250802531767
-
G. Lappin R. C. Garner 2008 The utility of microdosing over the past 5 years Expert Opin. Drug Metab. Toxicol. 4 1499 1506 19040326 1:CAS:528:DC%2BD1cXhsVent7zN 10.1517/17425250802531767
-
(2008)
Expert Opin. Drug Metab. Toxicol.
, vol.4
, pp. 1499-1506
-
-
Lappin, G.1
Garner, R.C.2
-
19
-
-
79956356127
-
Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers
-
21540108 1:CAS:528:DC%2BC3MXmvFSkt7g%3D 10.1016/j.ejps.2011.04.009
-
G. Lappin Y. Shishikura R. Jochemsen R. J. Weaver C. Gesson J. Brian Houston B. Oosterhuis O. J. Bjerrum G. Grynkiewicz J. Alder M. Rowland C. Garner 2011 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 21540108 1:CAS:528:DC%2BC3MXmvFSkt7g%3D 10.1016/j.ejps.2011.04.009
-
(2011)
Eur. J. Pharm. Sci.
, vol.43
, pp. 141-150
-
-
Lappin, G.1
Shishikura, Y.2
Jochemsen, R.3
Weaver, R.J.4
Gesson, C.5
Brian Houston, J.6
Oosterhuis, B.7
Bjerrum, O.J.8
Grynkiewicz, G.9
Alder, J.10
Rowland, M.11
Garner, C.12
-
20
-
-
62949142378
-
Early human studies of investigational agents: Dose or microdose?
-
19523010 10.1111/j.1365-2125.2009.03397.x
-
L. D. Lewis 2009 Early human studies of investigational agents: dose or microdose? Br. J. Clin. Pharmacol. 67 277 279 19523010 10.1111/j.1365-2125.2009. 03397.x
-
(2009)
Br. J. Clin. Pharmacol.
, vol.67
, pp. 277-279
-
-
Lewis, L.D.1
-
21
-
-
0346497617
-
14C in Nonvolatile Samples by Accelerator Mass Spectrometry
-
DOI 10.1021/ac030181y
-
14C in nonvolatile samples by accelerator mass spectrometry Anal. Chem. 76 328 334 14719879 1:CAS:528:DC%2BD3sXpsFaqs74%3D 10.1021/ac030181y (Pubitemid 38090768)
-
(2004)
Analytical Chemistry
, vol.76
, Issue.2
, pp. 328-334
-
-
Liberman, R.G.1
Tannenbaum, S.R.2
Hughey, B.J.3
Shefer, R.E.4
Klinkowstein, R.E.5
Prakash, C.6
Harriman, S.P.7
Skipper, P.L.8
-
22
-
-
62949126634
-
A pharmacokinetic evaluation of five H(1) antagonists after an oral and intravenous microdose to human subjects
-
19523012 1:CAS:528:DC%2BD1MXlt1Gmsb8%3D 10.1111/j.1365-2125.2008.03351.x
-
A. Madan Z. O'Brien J. Wen C. O'Brien R. H. Farber G. Beaton P. Crowe B. Oosterhuis R. C. Garner G. Lappin H. P. Bozigian 2009 A pharmacokinetic evaluation of five H(1) antagonists after an oral and intravenous microdose to human subjects Br. J. Clin. Pharmacol. 67 288 298 19523012 1:CAS:528: DC%2BD1MXlt1Gmsb8%3D 10.1111/j.1365-2125.2008.03351.x
-
(2009)
Br. J. Clin. Pharmacol.
, vol.67
, pp. 288-298
-
-
Madan, A.1
O'Brien, Z.2
Wen, J.3
O'Brien, C.4
Farber, R.H.5
Beaton, G.6
Crowe, P.7
Oosterhuis, B.8
Garner, R.C.9
Lappin, G.10
Bozigian, H.P.11
-
23
-
-
34548324267
-
The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials
-
DOI 10.1038/sj.bjc.6603925, PII 6603925
-
S. Marchetti J. H. Schellens 2007 The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials Br. J. Cancer 97 577 581 17726450 1:CAS:528:DC%2BD2sXpsF2ksb4%3D 10.1038/sj.bjc.6603925 (Pubitemid 47339894)
-
(2007)
British Journal of Cancer
, vol.97
, Issue.5
, pp. 577-581
-
-
Marchetti, S.1
Schellens, J.H.M.2
-
24
-
-
70349482953
-
Novel trends in high-throughput screening
-
19775937 1:CAS:528:DC%2BD1MXht1WntLnL 10.1016/j.coph.2009.08.004
-
L. M. Mayr D. Bojanic 2009 Novel trends in high-throughput screening Curr. Opin. Pharmacol. 9 580 588 19775937 1:CAS:528:DC%2BD1MXht1WntLnL 10.1016/j.coph.2009.08.004
-
(2009)
Curr. Opin. Pharmacol.
, vol.9
, pp. 580-588
-
-
Mayr, L.M.1
Bojanic, D.2
-
25
-
-
67649306825
-
14C-labeled drug and accelerator mass spectrometry to measure absolute oral bioavailability in dogs; Cross-comparison of assay methods by accelerator mass spectrometry and liquid chromatographytandem mass spectrometry
-
19430168 1:CAS:528:DC%2BD1MXnsF2ksbc%3D 10.2133/dmpk.24.130
-
14C-labeled drug and accelerator mass spectrometry to measure absolute oral bioavailability in dogs; cross-comparison of assay methods by accelerator mass spectrometry and liquid chromatographytandem mass spectrometry Drug Metab. Pharmacokinet. 24 130 138 19430168 1:CAS:528:DC%2BD1MXnsF2ksbc%3D 10.2133/dmpk.24.130
-
(2009)
Drug Metab. Pharmacokinet.
, vol.24
, pp. 130-138
-
-
Miyaji, Y.1
Ishizuka, T.2
Kawai, K.3
Hamabe, Y.4
Miyaoka, T.5
Oh-Hara, T.6
Ikeda, T.7
Kurihara, A.8
-
26
-
-
83655168371
-
Microdosing in translational medicine: Pros and cons
-
Mucke, H. A. M., Microdosing in translational medicine: pros and cons. CHI Insight Pharma Reports, 2006
-
(2006)
CHI Insight Pharma Reports
-
-
Mucke, H.A.M.1
-
27
-
-
38349095115
-
Innovative early development regulatory approaches: ExpIND, expCTA, microdosing
-
18091759 1:STN:280:DC%2BD1c%2FkvValsg%3D%3D 10.1038/sj.clpt.6100461
-
W. T. Robinson 2008 Innovative early development regulatory approaches: expIND, expCTA, microdosing Clin. Pharmacol. Ther. 83 358 360 18091759 1:STN:280:DC%2BD1c%2FkvValsg%3D%3D 10.1038/sj.clpt.6100461
-
(2008)
Clin. Pharmacol. Ther.
, vol.83
, pp. 358-360
-
-
Robinson, W.T.1
-
28
-
-
62549109149
-
FemtoMolar measurements using accelerator mass spectrometry
-
19177507 1:CAS:528:DC%2BD1MXivVaqtL8%3D 10.1002/rcm.3903
-
M. Salehpour N. Forsgard G. Possnert 2009 FemtoMolar measurements using accelerator mass spectrometry Rapid Commun. Mass Spectrom. 23 557 563 19177507 1:CAS:528:DC%2BD1MXivVaqtL8%3D 10.1002/rcm.3903
-
(2009)
Rapid Commun. Mass Spectrom.
, vol.23
, pp. 557-563
-
-
Salehpour, M.1
Forsgard, N.2
Possnert, G.3
-
29
-
-
77951918031
-
Accelerator mass spectrometry offers new opportunities for microdosing of peptide and protein pharmaceuticals
-
20411588 1:CAS:528:DC%2BC3cXltVyqtbw%3D 10.1002/rcm.4544
-
M. Salehpour J. Ekblom V. Sabetsky K. Håkansson G. Possnert 2010 Accelerator mass spectrometry offers new opportunities for microdosing of peptide and protein pharmaceuticals Rapid Commun. Mass Spectrom. 24 1481 1489 20411588 1:CAS:528:DC%2BC3cXltVyqtbw%3D 10.1002/rcm.4544
-
(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
-
30
-
-
25444451050
-
14C-nelfinavir mesylate solution and oral nelfinavir to healthy volunteers
-
DOI 10.1177/0091270005280051
-
14C- nelfinavir mesylate solution and oral nelfinavir to healthy volunteers J. Clin. Pharmacol. 45 1198 1205 16172185 1:CAS:528:DC%2BD2MXhtFeqs77J 10.1177/0091270005280051 (Pubitemid 41361920)
-
(2005)
Journal of Clinical Pharmacology
, vol.45
, Issue.10
, pp. 1198-1205
-
-
Sarapa, N.1
Hsyu, P.-H.2
Lappin, G.3
Garner, R.C.4
-
31
-
-
84855467372
-
-
2004 US FDA, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products
-
US FDA, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. http://www.fda.gov/ScienceResearch/ SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262. htm (2004).
-
-
-
-
32
-
-
84855467373
-
-
2006 US FDA, Investigators, and Reviewers Exploratory IND Studies
-
US FDA, Investigators, and Reviewers Exploratory IND Studies. http://www.fda.gov/ohrms/dockets/98fr/05d-0122-gdl0002.pdf (2006).
-
-
-
-
34
-
-
84877193336
-
Accelerator mass spectrometry
-
9306729 1:CAS:528:DyaK2MXlvVymsrw%3D 10.1021/ac00107a001
-
J. S. Vogel K. W. Turteltaub R. Finkel D. E. Nelson 1995 Accelerator mass spectrometry Anal. Chem. 67 353A 359A 9306729 1:CAS:528:DyaK2MXlvVymsrw%3D 10.1021/ac00107a001
-
(1995)
Anal. Chem.
, vol.67
-
-
Vogel, J.S.1
Turteltaub, K.W.2
Finkel, R.3
Nelson, D.E.4
-
35
-
-
49449110661
-
Use of accelerator mass spectrometry to measure the pharmacokinetics and peripheral blood mononuclear cell concentrations of zidovudine
-
1:CAS:528:DC%2BD1cXotF2ls78%3D 10.1002/jps.21160
-
l. T. Vuong J. L. Ruckle A. B. Blood M. J. Reid R. D. Wasnich H. A. Synal S. R. Dueker 2008 Use of accelerator mass spectrometry to measure the pharmacokinetics and peripheral blood mononuclear cell concentrations of zidovudine J. Pharm. Sci. 97 2833 2843 1:CAS:528:DC%2BD1cXotF2ls78%3D 10.1002/jps.21160
-
(2008)
J. Pharm. Sci.
, vol.97
, pp. 2833-2843
-
-
Vuong, L.T.1
Ruckle, J.L.2
Blood, A.B.3
Reid, M.J.4
Wasnich, R.D.5
Synal, H.A.6
Dueker, S.R.7
-
36
-
-
21544448884
-
Improved early clinical development through human microdosing studies
-
DOI 10.1016/S1359-6446(05)03509-9, PII S1359644605035099
-
I. R. Wilding J. A. Bell 2005 Improved early clinical development through human microdosing studies Drug Discov. Today 10 890 894 15993808 10.1016/S1359-6446(05)03509-9 (Pubitemid 40922787)
-
(2005)
Drug Discovery Today
, vol.10
, Issue.13
, pp. 890-894
-
-
Wilding, I.R.1
Bell, J.A.2
-
37
-
-
34848908357
-
Microdose clinical trial: Quantitative determination of fexofenadine in human plasma using liquid chromatography/electrospray ionization tandem mass spectrometry
-
DOI 10.1016/j.jchromb.2007.08.011, PII S1570023207005673
-
N. Yamane Z. Tozuka Y. Sugiyama T. Tanimoto A. Yamazaki Y. Kumagai 2007 Microdose clinical trial: quantitative determination of fexofenadine in human plasma using liquid chromatography/electrospray ionization tandem mass spectrometry J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 858 118 128 17804306 1:CAS:528:DC%2BD2sXhtFCjs7fE 10.1016/j.jchromb.2007.08.011 (Pubitemid 47513599)
-
(2007)
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
, vol.858
, Issue.1-2
, pp. 118-128
-
-
Yamane, N.1
Tozuka, Z.2
Sugiyama, Y.3
Tanimoto, T.4
Yamazaki, A.5
Kumagai, Y.6
-
38
-
-
0034830621
-
Accelerator mass spectrometry (AMS): Recent experience of its use in a clinical study and the potential future of the technique
-
DOI 10.1080/00498250110052724
-
G. Young W. Ellis J. Ayrton E. Hussey B. Adamkiewicz 2001 Accelerator mass spectrometry (AMS): recent experience of its use in a clinical study and the potential future of the technique Xenobiotica 31 619 632 11569529 1:CAS:528:DC%2BD3MXmvF2lt7g%3D 10.1080/00498250110052724 (Pubitemid 32826395)
-
(2001)
Xenobiotica
, vol.31
, Issue.8-9
, pp. 619-632
-
-
Young, G.1
Ellis, W.2
Ayrton, J.3
Hussey, E.4
Adamkiewicz, B.5
|