-
1
-
-
34047177929
-
Biomarker qualification pilot process at the US Food and Drug Administration
-
Goodsaid F, Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J. 9(1), 10 (2007).
-
(2007)
AAPS J.
, vol.9
, Issue.1
, pp. 10
-
-
Goodsaid, F.1
Frueh, F.2
-
2
-
-
33847184252
-
Workshop/Conference Report - Quantitative bioanalyitcal methods validation and implementation: Best practices for chromatographic and ligand binding assays
-
Viswanathan CT, Bansal S, Booth B et al. Workshop/Conference Report - quantitative bioanalyitcal methods validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1), 4 (2007).
-
(2007)
AAPS J.
, vol.9
, Issue.1
, pp. 4
-
-
Viswanathan, C.T.1
Bansal, S.2
Booth, B.3
-
3
-
-
0003484310
-
-
US FDA. US Department of Health and Human Services, US FDA, Centre for Drug Evaluation and Research, Rockville, MD, USA
-
US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Centre for Drug Evaluation and Research, Rockville, MD, USA (2001).
-
(2001)
Guidance for Industry: Bioanalytical Method Validation
-
-
-
4
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurment
-
Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurment. Pharm. Res. 23(2), 312-328 (2006).
-
(2006)
Pharm. Res.
, vol.23
, Issue.2
, pp. 312-328
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
-
5
-
-
10744230729
-
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
-
DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20, 1885-1900 (2003).
-
(2003)
Pharm. Res.
, vol.20
, pp. 1885-1900
-
-
Desilva, B.1
Smith, W.2
Weiner, R.3
-
6
-
-
0043270582
-
Liquid chromatography/tandem mass spectrometry methods for quantitation of mevalonic acid in human plasma and urine: Method validation, demonstration of using a surrogate analyte and demonstration of unacceptable matrix effect in spite of use of a stable isotope analog internal standard
-
Jemal M, Schuster A, Whigan D. Liquid chromatography/tandem mass spectrometry methods for quantitation of mevalonic acid in human plasma and urine: method validation, demonstration of using a surrogate analyte and demonstration of unacceptable matrix effect in spite of use of a stable isotope analog internal standard. Rapid Commun. Mass Spectrom. 17, 1723-1734 (2003).
-
(2003)
Rapid Commun. Mass Spectrom.
, vol.17
, pp. 1723-1734
-
-
Jemal, M.1
Schuster, A.2
Whigan, D.3
-
7
-
-
58949095596
-
Development and validation of an LC-MS/ MS method for quantification of cyclic guanosine 3′,5′-monophosphate (cGMP) in clinical application: A comparison with an EIA method
-
Zhang Y, Dufield D, Klover J et al. Development and validation of an LC-MS/ MS method for quantification of cyclic guanosine 3′,5′- monophosphate (cGMP) in clinical application: a comparison with an EIA method. J. Chrom. B 877, 513-520 (2009).
-
(2009)
J. Chrom. B
, vol.877
, pp. 513-520
-
-
Zhang, Y.1
Dufield, D.2
Klover, J.3
-
8
-
-
33845761419
-
Does a stable isotopically labeled internal standard always correct analyte response? A matrix effect study on LC/MS/MS method for the determination of carvediol enantiomers in human plasma
-
Wang S, Cyronak M, Yang E. Does a stable isotopically labeled internal standard always correct analyte response? A matrix effect study on LC/MS/MS method for the determination of carvediol enantiomers in human plasma. J. Pharm. Biomed. Anal. 43, 701-707 (2007).
-
(2007)
J. Pharm. Biomed. Anal.
, vol.43
, pp. 701-707
-
-
Wang, S.1
Cyronak, M.2
Yang, E.3
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