-
1
-
-
25844468887
-
-
European Medicines Agency Guideline on Bioanalytical Method Validation. European Medicines Agency London, UK
-
European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on Bioanalytical Method Validation. European Medicines Agency, London, UK (2011).
-
(2011)
Committee for Medicinal Products for Human Use
-
-
-
2
-
-
84859127820
-
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
-
Boterman M, Doig M, Breda M et al. Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). Bioanalysis 4(6), 651-660 (2012).
-
(2012)
Bioanalysis
, vol.4
, Issue.6
, pp. 651-660
-
-
Boterman, M.1
Doig, M.2
Breda, M.3
-
3
-
-
84867355005
-
2012 White Paper on recent issues in bioanalysis and alignment of multiple guidelines
-
DeSilva B, Garofolo F, Rocci M et al. 2012 White Paper on recent issues in bioanalysis and alignment of multiple guidelines. Bioanalysis 4(18), 2213-2226 (2012).
-
(2012)
Bioanalysis
, vol.4
, Issue.18
, pp. 2213-2226
-
-
Desilva, B.1
Garofolo, F.2
Rocci, M.3
-
4
-
-
84875029552
-
The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency Guideline on Bioanalytical Method Validation
-
van Amsterdam P, Companjen A, Brudny-Kloeppel M et al. The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency Guideline on Bioanalytical Method Validation. Bioanalysis 5(6), 645-659 (2013).
-
(2013)
Bioanalysis
, vol.5
, Issue.6
, pp. 645-659
-
-
Van Amsterdam, P.1
Companjen, A.2
Brudny-Kloeppel, M.3
-
5
-
-
32544451155
-
Fit-for-purpose method development and validation for successful biomarker measurement
-
Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. 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
-
6
-
-
79956075204
-
Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies
-
Valentin MA, Ma S, Zhao A, Legay F, Avrameas A. Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J. Pharm. Biomed. Anal. 55(5), 869-877 (2011).
-
(2011)
J. Pharm. Biomed. Anal.
, vol.55
, Issue.5
, pp. 869-877
-
-
Valentin, M.A.1
Ma, S.2
Zhao, A.3
Legay, F.4
Avrameas, A.5
-
7
-
-
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(11), 1885-1900 (2003).
-
(2003)
Pharm. Res.
, vol.20
, Issue.11
, pp. 1885-1900
-
-
Desilva, B.1
Smith, W.2
Weiner, R.3
-
8
-
-
79953108779
-
Biotherapeutic bioanalysis: A multi-indication case study review
-
Myler HA, Given A, Kolz K, Mora JR, Hristopoulos G. Biotherapeutic bioanalysis: a multi-indication case study review. Bioanalysis 3(6), 623-643 (2011).
-
(2011)
Bioanalysis
, vol.3
, Issue.6
, pp. 623-643
-
-
Myler, H.A.1
Given, A.2
Kolz, K.3
Mora, J.R.4
Hristopoulos, G.5
-
9
-
-
84892761988
-
Consensus and recommendations of the L2 Global harmonization team, large molecule specific assay operation for ligand binding assays in support of pharmacometrics
-
doi:10.1208/s12248-013-9542-y Epub ahead of print
-
Stevenson L, Kelley M, Gorovits B et al. Consensus and recommendations of the L2 Global harmonization team, large molecule specific assay operation for ligand binding assays in support of pharmacometrics. AAPS J. doi:10.1208/s12248-013-9542-y (2013) (Epub ahead of print).
-
(2013)
AAPS J.
-
-
Stevenson, L.1
Kelley, M.2
Gorovits, B.3
-
10
-
-
77950524946
-
Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients
-
Myler HA, McVay S, Kratzsch J. Troubleshooting PEG-hGH detection supporting pharmacokinetic evaluation in growth hormone deficient patients. J. Pharmacol. Toxicol. Methods 61(2), 92-97 (2010).
-
(2010)
J. Pharmacol. Toxicol. Methods
, vol.61
, Issue.2
, pp. 92-97
-
-
Myler, H.A.1
McVay, S.2
Kratzsch, J.3
-
11
-
-
84861874637
-
® a CTLA-4-Fc fusion protein, in renal and liver transplant patients
-
Myler HA, Phillips KR, Dong H et al. Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4-Fc fusion protein, in renal and liver transplant patients. Bioanalysis 4(10), 1215-1226 (2012).
-
(2012)
Bioanalysis
, vol.4
, Issue.10
, pp. 1215-1226
-
-
Myler, H.A.1
Phillips, K.R.2
Dong, H.3
-
12
-
-
84890390856
-
White Paper on recent issues in bioanalysis: 'hybrid'- The best of LBA and LCMS
-
Stevenson L, Garofolo F, DeSilva B et al. 2013 White Paper on recent issues in bioanalysis: 'hybrid'-the best of LBA and LCMS. Bioanalysis 5(23), 2903-2918 (2013).
-
(2013)
Bioanalysis
, vol.5
, Issue.23
, pp. 2903-2918
-
-
Stevenson, L.1
Garofolo, F.2
Desilva, B.3
-
13
-
-
79951980085
-
Bioanalytical approaches to quantify 'total' and 'free' therapeutic antibodies and their targets: Technical challenges and PK/PD applications over the course of drug development
-
Lee JW, Kelley M, King LE et al. Bioanalytical approaches to quantify 'total' and 'free' therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 13(1), 99-110 (2013).
-
(2013)
AAPS J.
, vol.13
, Issue.1
, pp. 99-110
-
-
Lee, J.W.1
Kelley, M.2
King, L.E.3
-
14
-
-
84877245142
-
Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper
-
Gorovits B, Alley, SC, Bilic S et al. Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper. Bioanalysis 5(9), 997-1006 (2013).
-
(2013)
Bioanalysis
, vol.5
, Issue.9
, pp. 997-1006
-
-
Gorovits, B.1
Alley, S.C.2
Bilic, S.3
-
15
-
-
84882286058
-
What is going on with my samples? A general approach to parallelism assessment and data interpretation for biomarker ligand-binding assays
-
Ciotti S, Purushothama S, Ray S. What is going on with my samples? A general approach to parallelism assessment and data interpretation for biomarker ligand-binding assays. Bioanalysis 5(16), 1941-1943 (2013).
-
(2013)
Bioanalysis
, vol.5
, Issue.16
, pp. 1941-1943
-
-
Ciotti, S.1
Purushothama, S.2
Ray, S.3
-
16
-
-
18744391651
-
Measuring parallelism, linearity, and relative potency in bioassay and immunoassay data
-
Gottschalk PG, Dunn JR. Measuring parallelism, linearity, and relative potency in bioassay and immunoassay data. J. Biopharm. Stat. 15(3), 437-463 (2005).
-
(2005)
J. Biopharm. Stat.
, vol.15
, Issue.3
, pp. 437-463
-
-
Gottschalk, P.G.1
Dunn, J.R.2
-
17
-
-
0020406969
-
Lack of parallelism in antibody responses as measured by enzyme immunoassay after infection due to influenza virus A/USSR/77 (H1N1)
-
Hammond GW, Noble GR, Smith SJ. Lack of parallelism in antibody responses as measured by enzyme immunoassay after infection due to influenza virus A/USSR/77 (H1N1). J. Infect. Dis. 146(6), 827 (1982).
-
(1982)
J. Infect. Dis.
, vol.146
, Issue.6
, pp. 827
-
-
Hammond, G.W.1
Noble, G.R.2
Smith, S.J.3
-
18
-
-
0022730412
-
Beta-Lactoglobulin and alpha-lactalbumin in mammary secretions during the dry period: Parallelism of concentration changes
-
Hurley WL, Rejman JJ. beta-Lactoglobulin and alpha-lactalbumin in mammary secretions during the dry period: parallelism of concentration changes. J. Dairy Sci. 69(6), 1642-1647 (1986).
-
(1986)
J. Dairy Sci.
, vol.69
, Issue.6
, pp. 1642-1647
-
-
Hurley, W.L.1
Rejman, J.J.2
-
19
-
-
4444355044
-
Statistical correction for non-parallelism in a urinary enzyme immunoassay
-
O'Connor KA, Brindle E, Shofer JB et al. Statistical correction for non-parallelism in a urinary enzyme immunoassay. J. Immunoassay Immunochem. 25(3), 259-278 (2004).
-
(2004)
J. Immunoassay Immunochem.
, vol.25
, Issue.3
, pp. 259-278
-
-
O'Connor, K.A.1
Brindle, E.2
Shofer, J.B.3
-
20
-
-
0028048784
-
Determination of parallelism and nonparallelism in bioassay dilution curves
-
Plikaytis BD, Holder PF, Pais LB, Maslanka SE, Gheesling LL, Carlone GM. Determination of parallelism and nonparallelism in bioassay dilution curves. J. Clin. Microbiol. 32(10), 2441-2447 (1994).
-
(1994)
J. Clin. Microbiol.
, vol.32
, Issue.10
, pp. 2441-2447
-
-
Plikaytis, B.D.1
Holder, P.F.2
Pais, L.B.3
Maslanka, S.E.4
Gheesling, L.L.5
Carlone, G.M.6
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