-
1
-
-
48249134915
-
-
PhRMA report. Available at Accessed April 24, 2008
-
PhRMA report. Medicines in Development, Biotechnology, 2006. Available at http://www.phrma.org/files/biotech%202006.pdf. Accessed April 24, 2008.
-
(2006)
Medicines in Development, Biotechnology
-
-
-
2
-
-
0026606194
-
Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetics studies
-
V. P. Shah, K. K. Midha, S. Dighe, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetics studies. Pharm. Res. 9:588-592 (1992).
-
(1992)
Pharm. Res.
, vol.9
, pp. 588-592
-
-
Shah, V.P.1
Midha, K.K.2
Dighe, S.3
-
3
-
-
0034469255
-
Bioanalytical method validation - A revisit with a decade of progress
-
V. P. Shah, K. K. Midha, J. W. A. Findlay, et al. Bioanalytical method validation - a revisit with a decade of progress. Pharm. Res. 17:1551-1557 (2000).
-
(2000)
Pharm. Res.
, vol.17
, pp. 1551-1557
-
-
Shah, V.P.1
Midha, K.K.2
Findlay, J.W.A.3
-
4
-
-
33847184252
-
Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand-binding assays
-
C. T. Viswanathan, S. Bansal, B. Booth, et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand-binding assays. AAPS J. 9:E30-E42 (2007).
-
(2007)
AAPS J.
, vol.9
-
-
Viswanathan, C.T.1
Bansal, S.2
Booth, B.3
-
5
-
-
0033989957
-
Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective
-
J. W. A. Findlay, W. C. Smith, J. W. Lee, et al. Validation of immunoassays for bioanalysis: A pharmaceutical industry perspective. J. Pharm. Biomed. Anal. 21:1249-1273 (2000).
-
(2000)
J. Pharm. Biomed. Anal.
, vol.21
, pp. 1249-1273
-
-
Findlay, J.W.A.1
Smith, W.C.2
Lee, J.W.3
-
6
-
-
0034852176
-
Workshop on bioanalytical methods validation for macromolecules: Summary report
-
K. J. Miller, R. R. Bowsher, A. Celniker, et al. Workshop on bioanalytical methods validation for macromolecules: Summary report. Pharm. Res. 18:1373-1383 (2001).
-
(2001)
Pharm. Res.
, vol.18
, pp. 1373-1383
-
-
Miller, K.J.1
Bowsher, R.R.2
Celniker, A.3
-
7
-
-
10744230729
-
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
-
B. DeSilva, W. Smith, R. Weiner, 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
-
8
-
-
0003484310
-
-
Food and Drug Administration. US Department of Heath and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD
-
Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation, US Department of Heath and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD, 2001.
-
(2001)
Guidance for Industry: Bioanalytical Method Validation
-
-
-
9
-
-
20944433395
-
Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. A conference report
-
J. W. Lee, R. S. Weiner, J. M. Sailstad, et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. A conference report. Pharm. Res. 22: 499-511 (2005).
-
(2005)
Pharm. Res.
, vol.22
, pp. 499-511
-
-
Lee, J.W.1
Weiner, R.S.2
Sailstad, J.M.3
-
10
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurement
-
J. W. Lee, V. Devanarayan, Y. C. Barrett, et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23:312-328 (2006).
-
(2006)
Pharm. Res.
, vol.23
, pp. 312-328
-
-
Lee, J.W.1
Devanarayan, V.2
Barrett, Y.C.3
-
12
-
-
34547850227
-
Evaluation of a peptide ELISA for the detection of rituximab in serum
-
H. Blasco, G. Lalmanach, E. Godat, et al. Evaluation of a peptide ELISA for the detection of rituximab in serum. J. Immunol. Methods. 325:127-139 (2007).
-
(2007)
J. Immunol. Methods
, vol.325
, pp. 127-139
-
-
Blasco, H.1
Lalmanach, G.2
Godat, E.3
-
13
-
-
0026488120
-
The role of pharmacokinetics in the development of biotechnologically derived agents
-
R. J. Wills, and B. L. Ferraiolo. The role of pharmacokinetics in the development of biotechnologically derived agents. Clin. Pharmacokinet. 23:406-414 (1992).
-
(1992)
Clin. Pharmacokinet
, vol.23
, pp. 406-414
-
-
Wills, R.J.1
Ferraiolo, B.L.2
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