-
3
-
-
18644385994
-
Drug metabolites in safety testing
-
Baillie, T. A., Cayen, M. N., Fouda, H., Gerson, R. J., Green, J. D., Grossman, S. J., Klunk, L. J., LeBlanc, B., Perkins, D. G., and Shipley, L. A. (2002) Drug metabolites in safety testing. Toxicol. Appl. Pharmacol. 182, 188-96.
-
(2002)
Toxicol. Appl. Pharmacol
, vol.182
, pp. 188-196
-
-
Baillie, T.A.1
Cayen, M.N.2
Fouda, H.3
Gerson, R.J.4
Green, J.D.5
Grossman, S.J.6
Klunk, L.J.7
LeBlanc, B.8
Perkins, D.G.9
Shipley, L.A.10
-
4
-
-
24944563781
-
-
Smith, D. A., and Obach, R. S. (2005) Seeing through the MIST: Abundance versus percentage. Commentary of metabolites in safety testing. Drug Metab. Dispos. Fast Forward, DOI: 10.1124/ dmd.105.005041.
-
Smith, D. A., and Obach, R. S. (2005) Seeing through the MIST: Abundance versus percentage. Commentary of metabolites in safety testing. Drug Metab. Dispos. Fast Forward, DOI: 10.1124/ dmd.105.005041.
-
-
-
-
5
-
-
33845734598
-
A regulatory perspective on issues and approaches in characterizing human metabolites
-
Davis-Bruno, K. L., and Atrakchi, A. (2006) A regulatory perspective on issues and approaches in characterizing human metabolites. Chem. Res. Toxicol. 19, 1561-1563.
-
(2006)
Chem. Res. Toxicol
, vol.19
, pp. 1561-1563
-
-
Davis-Bruno, K.L.1
Atrakchi, A.2
-
6
-
-
33845792941
-
Safety assessment of stable drug metabolites
-
Guengerich, F. P. (2006) Safety assessment of stable drug metabolites. Chem. Res. Toxicol. 19, 1559-1560.
-
(2006)
Chem. Res. Toxicol
, vol.19
, pp. 1559-1560
-
-
Guengerich, F.P.1
-
7
-
-
33845769325
-
Safety assessment of drug metabolites: Characterization of chemically stable metabolites
-
Humphreys, W. G., and Unger, S. E. (2006) Safety assessment of drug metabolites: characterization of chemically stable metabolites. Chem. Res. Toxicol. 19, 1564-1569.
-
(2006)
Chem. Res. Toxicol
, vol.19
, pp. 1564-1569
-
-
Humphreys, W.G.1
Unger, S.E.2
-
8
-
-
33751249069
-
Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites
-
Prueksaritanont, T., Lin, J. H., and Baillie, T. A. (2006) Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites. Toxicol. Appl. Pharmacol. 217, 143-152.
-
(2006)
Toxicol. Appl. Pharmacol
, vol.217
, pp. 143-152
-
-
Prueksaritanont, T.1
Lin, J.H.2
Baillie, T.A.3
-
9
-
-
33845748169
-
Metabolites and safety: What are the concerns, and how should we address them?
-
Smith, D. A., and Obach, R. S. (2006) Metabolites and safety: What are the concerns, and how should we address them? Chem. Res. Toxicol. 19, 1570-1579.
-
(2006)
Chem. Res. Toxicol
, vol.19
, pp. 1570-1579
-
-
Smith, D.A.1
Obach, R.S.2
-
10
-
-
35648982920
-
Current opinion: Safety evaluation of drug metabolites in development of phaimaceuticals
-
Naito, S., Furuta, S., Yoshida, T., Kitada, O., Unno, T., Ohno, Y., Kawamura, N., Kurokawa, M., Sagami, F., Shinoda, K., Nakazawa, T., and Yamazaki, T. (2007) Current opinion: Safety evaluation of drug metabolites in development of phaimaceuticals. J. Toxicol. Sci. 32 (4), 329-341.
-
(2007)
J. Toxicol. Sci
, vol.32
, Issue.4
, pp. 329-341
-
-
Naito, S.1
Furuta, S.2
Yoshida, T.3
Kitada, O.4
Unno, T.5
Ohno, Y.6
Kawamura, N.7
Kurokawa, M.8
Sagami, F.9
Shinoda, K.10
Nakazawa, T.11
Yamazaki, T.12
-
11
-
-
47649088457
-
Unique/major human metabolites: Why, how, and when to test for safety in animals
-
Luffer-Atlas, D. (2008) Unique/major human metabolites: Why, how, and when to test for safety in animals. Drug Metab. Rev. 40, 447-463.
-
(2008)
Drug Metab. Rev
, vol.40
, pp. 447-463
-
-
Luffer-Atlas, D.1
-
12
-
-
62249093933
-
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1997) Guideline S1b: Testing for Carcinogenicity of Pharmaceuticals, ICH Steering Committee
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1997) Guideline S1b: Testing for Carcinogenicity of Pharmaceuticals, ICH Steering Committee.
-
-
-
-
13
-
-
62249100774
-
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005) Guideline S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, ICH Steering Committee
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005) Guideline S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, ICH Steering Committee.
-
-
-
-
14
-
-
62249210386
-
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2006a) Guideline S1C(R2, Revision of ICH S1C and S1CR1, Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose, ICH Steering Committee
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2006a) Guideline S1C(R2) [Revision of ICH S1C and S1C(R1)] Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose, ICH Steering Committee.
-
-
-
-
15
-
-
62249143668
-
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2006b) Guideline M3(R2, Revision of ICH MSR1, Maintenance of the ICH Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, ICH Steering Committee
-
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2006b) Guideline M3(R2): Revision of ICH MS(R1): Maintenance of the ICH Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, ICH Steering Committee.
-
-
-
-
17
-
-
33847166320
-
A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection
-
Yu, C. P., Chen, C. L., Gorycki, F. L., and Neiss, T. G. (2007) A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection. Rapid Commun. Mass Spectrom. 21, 497-502.
-
(2007)
Rapid Commun. Mass Spectrom
, vol.21
, pp. 497-502
-
-
Yu, C.P.1
Chen, C.L.2
Gorycki, F.L.3
Neiss, T.G.4
-
18
-
-
58149333524
-
Fractional mass filtering as a means to assess circulating metabolites in early human clinical studies
-
Tiller, P. R., Yu, S., Bateman, K. P., Castro-Perez, J., McIntosh, I. S., Kuo, Y., and Baillie, T. A. (2008) Fractional mass filtering as a means to assess circulating metabolites in early human clinical studies. Rapid Commun. Mass Spectrom. 22, 3510-3516.
-
(2008)
Rapid Commun. Mass Spectrom
, vol.22
, pp. 3510-3516
-
-
Tiller, P.R.1
Yu, S.2
Bateman, K.P.3
Castro-Perez, J.4
McIntosh, I.S.5
Kuo, Y.6
Baillie, T.A.7
-
19
-
-
33748902567
-
Detection and characterization of metabolites in biological matrices using mass defect filtering of liquid chromatography/high resolution mass spectrometry data
-
Zhu, M., Ma, L., Zhang, D., Ray, K., Zhao, W., Humphreys, W. G., Skiles, G., Sanders, M., and Zhang, H. (2006) Detection and characterization of metabolites in biological matrices using mass defect filtering of liquid chromatography/high resolution mass spectrometry data. Drug Metab. Dispos. 34, 1722-1733.
-
(2006)
Drug Metab. Dispos
, vol.34
, pp. 1722-1733
-
-
Zhu, M.1
Ma, L.2
Zhang, D.3
Ray, K.4
Zhao, W.5
Humphreys, W.G.6
Skiles, G.7
Sanders, M.8
Zhang, H.9
-
20
-
-
51049120013
-
Biomedical acceleratory mass spectrometry: Recent applications in metabolism and pharmacokinetics
-
Lappin, G., and Stevens, L. (2008) Biomedical acceleratory mass spectrometry: recent applications in metabolism and pharmacokinetics. Expert Opin. Drug Metab. Toxicol. 4 (8), 1021-1033.
-
(2008)
Expert Opin. Drug Metab. Toxicol
, vol.4
, Issue.8
, pp. 1021-1033
-
-
Lappin, G.1
Stevens, L.2
-
21
-
-
33644827201
-
-
Food and Drug Administration , FDA, Rockville, MD
-
Food and Drug Administration (2006) Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, FDA, Rockville, MD.
-
(2006)
Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies
-
-
-
22
-
-
0033769965
-
Cyanide and thiocyanate levels in blood and saliva of healthy adult volunteers
-
Tsuge, K., Kataoka, M., and Seto, Y. (2000) Cyanide and thiocyanate levels in blood and saliva of healthy adult volunteers. J. Health Sci. 46, 343-350.
-
(2000)
J. Health Sci
, vol.46
, pp. 343-350
-
-
Tsuge, K.1
Kataoka, M.2
Seto, Y.3
-
23
-
-
84865415281
-
-
Food and Drug Administration , FDA, Rockville, MD
-
Food and Drug Administration (2006) Guidance for Industry (Draft): Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling, FDA, Rockville, MD.
-
(2006)
Guidance for Industry (Draft): Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling
-
-
|