Trends of Innovative Clinical Drug Development using AMS (Accelerator Mass Spectrometry) and ![]() |
Cho, Kyung Hee
(Seoul Medical Science Institute/Seoul Clinical Laboratories)
Lee, Hee Joo (BioCore) Choie, Hyung Sik (BioCore) Lee, Kyoung Ryul (Seoul Medical Science Institute/Seoul Clinical Laboratories) Dueker, Stephen R. (Eckert & Ziegler Vitalea Science) Shin, Young G. (College of Pharmacy, Chungnam National University) |
1 | Dueker, S. R., Sivaraman, L., Wang, J., Wang, L., Fung, N., Maxwell, B., Bonnie, W., Christopher, L., Arnold, M. and McNerney, M. : Placental transfer of a pegylated adnectin in guinea pig (abstract #: 2783), presented poster (http:// www.toxicology.org/AI/PUB/Tox/2012toxsup.pdf). |
2 | Roffey, S. J., Obach, R. S., Gedge, J. I. and Smith, D. A. : What is the objective of the mass balance study? A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs. Drug Metab. Rev. 39, 17 (2007). DOI ScienceOn |
3 | Lappin, G., Seymour, M., Gross, G., Jorgensen, M., Kall, M. and Kvaerno, L. : Meeting the MIST regulations: human metabolism in Phase I using AMS and a tiered bioanalytical approach. Bioanalysis 4, 407 (2012). DOI ScienceOn |
4 | Lappin, G. and Stevens, L.: Biomedical accelerator mass spectrometry : recent applications in metabolism and pharmacokinetics. Exp. Opin. Drug Metab.Toxicol. 4, 1021 (2008). DOI ScienceOn |
5 | Salehpour, M., Ekblom, J., Sabetsky, V., Hakansson, K. and Possnert, G. : Accelerator mass spectrometry offers new opportunities for microdosing of peptide and protein pharmaceuticals. Rap. Commun. Mass Spec. 24, 1481 (2010). DOI ScienceOn |
6 | Lappin, G., Seymour, M., Young, G., Higton, D. and Hill, H. M. : AMS method validation for quantitation in pharmacokinetic studies with concomitant extravascular and intravenous administration. Bioanalysis 3, 393 (2011). DOI ScienceOn |
7 | Garner, R. C. : Practical experience of using human microdosing with AMS analysis to obtain early human drug metabolism and PK data. Bioanalysis 2, 429 (2010). DOI ScienceOn |
8 | 식품의약품 안전청 : 한국 식약청 마이크로도징 가이드 라인. "의약품의 임상시험 수행과 품목허가를 위한 비임상시험 가이드라인, 2012, 6". |
9 | Graham, R. A., Lum, B. L., Morrison, G., Chang, I., Jorga, K., Dean, B., Shin, Y. G., Yue, Q., Mulder, T., Malhi, V., Xie, M., Low, J. A. and Hop, C. E. : A single dose mass balance study of the Hedgehog pathway inhibitor vismodigib (GDC-0449) in human using accelerator mass spectrometry. Drug Metab. Dispos. 39, 1460 (2011). DOI ScienceOn |
10 | ICH M3 guidance, http://www.ema.europa.eu/docs/en_GB/ document_li brary/Sci ent i fic_gui deline/2009/09/ WC500002720.pdf. |
11 | Smith, D. A. : The debate is over : accerelator MS provides the route to better drug-development paradigms/protocols. Bioanalysis 3, 391 (2011). DOI ScienceOn |
12 | Garner, R. C. : Accelerator mass spectrometry in pharmaceutical research and development-a new ultrasensitive analytical method for isotope measurement. Curr. Drug Metab. 1, 205 (2000). DOI |
13 | Dueker, S. R., Vuong, L. T., Lohstroh, P. N., Giacomo, J. A. and Vogel, J. S. : Quantifying exploratory low dose compounds in humans with AMS. Adv. Drug Del. Rev. 63, 518 (2011). DOI ScienceOn |
14 | Schulze-Koenig, T., Dueker, S. R., Giacomo, J., Suter, M., Vogel, J. S. and Synal, H. : BioMICADAS : Compact next generation AMS system for pharmaceutical science. Nuclear Instr. and Methods in Physics Res. sect B : Beam interactions with Materials and Atoms 268, 891 (2010). DOI ScienceOn |
15 | Lappin, G. and Garner, R. C. : Current perspectives of 14Cisotope measurement in biomedical accelerator mass spectrometry. Anal. Bioanal. Chem. 378, 356 (2004). DOI ScienceOn |
16 | FDA 2004 critical path initiative, http://www.fda.gov/ ScienceResearch/SpecialTopics/CriticalPathInitiative/ ucm076689.htm. |
17 | Madan, A., O'Brien, Z., Wen, J., O'Brien, C., Farber, R. H., Beaton, G., Crowe, P., Oosterhuis, B., Garner, R. C., Lappin, G. and Bozigian, H. P. : A Pharmacokinetic evaluation of five H(1) antagonists after an oral and intravenous microdose to human subjects. Br. J. Clin. Pharmacol. 67, 288 (2009). DOI ScienceOn |
18 | Ings, R. M. J. : Microdosing : a valuable tool for accelerating drug development and the role of bioanalytical methods in meeting the challenge. Bioanalysis 1, 1293 (2009). DOI ScienceOn |
19 | Lappin, G., Seymour, M., Young, G., Higton, D. and Hill, H. M. : An AMS method to determine analyte recovery from pharmacokinetic studies with concomitant extravascular and intravenous administration. Bioanalysis 3, 407 (2011). DOI ScienceOn |
20 | Lappin, G., Wagner, C. C., Langer, O. and Van de Merbel, N. : New Ultrasensitive detection technologies and techniques for use in microdosing studies. Bioanalysis 1, 357 (2009). DOI ScienceOn |
21 | Allison, M. : Reinventing clinical trials. Nat. Biotechnol. 30, 41 (2012). DOI ScienceOn |
22 | U.S. Food and drug administration : FDA MIST guidance, http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ucm079266.pdf. |
23 | Paul, S. M., Mytelka, D. S., Dunwiddie, C. T., Persinger, C. C., Munos, B. H., Lindborg, S. R. and Schacht, A. L. : How to improve R&D productivity : the pharmaceutical industry's grand challenge. Nat. Rev. Drug Discov. 9, 203 (2010). |
24 | Graham, R. A., Hop, C. E., Borin, M. T., Lum, B. L., Colburn, D., Chang, I., Shin, Y. G., Malhi, V., Low. J. A. and Dresser, M. J. : Single and multiple dose intravenous and oral pharmakinetics of the hedgehog pathway inhibitor vismodegib in healthy female subjects. Br. J. Clin. Pharmocol. 74, 788 (2012). DOI ScienceOn |
25 | Bae, S. K. and Shon, J. : Microdosing studies using accelerated mass spectrometry as exploratory investigational new drug trials. Arch. Pharm. Res. 34, 1789 (2011). DOI |
26 | Lappin, G. and Seymour, M. : Addressing metabolite safety during first-in-man studies using 14C-labeled drug and accelerator mass spectrometry. Bioanalysis 2, 1315 (2010). DOI ScienceOn |
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