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Key elements of bioanalytical method validation for macromolecules
M. Kelley
, and
B. DeSilva
AAPS.J.
9(2):E156-E163
(
2007
)
to
Antibodies
Binding
Chemistry
Immunoassay
Indicators
Ligands
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Monoclonal
Pharmaceutical
Pharmacokinetics
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Reagents
Reference
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Results
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Specificity
Standards
Substances
analysis
and
metabolism
methods
of
standards
by
kanefendt
on
Feb 5, 2010, 11:28 AM
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(0)
Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples
W. Nowatzke
, and
E. Woolf
AAPS.J.
9(2):E117-E122
(
2007
)
to
Animals
Binding
Biopharmaceutics
Chemistry
Control
Drug
Humans
Pharmaceutical
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Reference
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Solutions
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Standards
analysis
deficiency
metabolism
methods
of
standards
by
kanefendt
on
Feb 5, 2010, 11:28 AM
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(0)
Appropriate calibration curve fitting in ligand binding assays
J. W. Findlay
, and
R. F. Dillard
AAPS.J.
9(2):E260-E267
(
2007
)
to
&
Algorithms
Analytical
Binding
Calibration
Chemistry
Dose-Response
Drug
Ligands
Models
Pharmaceutical
Pharmacokinetics
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Protein
RANGE
Relationship
Reproducibility
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Results
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Statistical
analysis
and
data
metabolism
methods
numerical
of
response
statistics
by
kanefendt
on
Feb 5, 2010, 11:28 AM
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(0)
Critical ligand binding reagent preparation/selection: when specificity depends on reagents
B. Rup
, and
D. O'Hara
AAPS.J.
9(2):E148-E155
(
2007
)
to
Antibodies
Binding
Chemistry
Immunoassay
Indicators
Ligands
Monoclonal
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reproducibility
Research
Results
Safety
Sensitivity
Specificity
and
metabolism
methods
of
standards
by
kanefendt
on
Feb 5, 2010, 11:28 AM
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(0)
Bioanalytical method validation--a revisit with a decade of progress
V. P. Shah
,
K. K. Midha
,
J. W. Findlay
,
H. M. Hill
,
J. D. Hulse
,
I. J. McGilveray
,
G. McKay
,
K. J. Miller
,
R. N. Patnaik
,
M. L. Powell
,
A. Tonelli
,
C. T. Viswanathan
, and
A. Yacobi
Pharm.Res.
17(12):1551-1557
(
2000
)
to
Assay
Availability
Biological
Equivalency
Indicators
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reproducibility
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Therapeutic
analysis
and
of
by
kanefendt
on
Feb 5, 2010, 11:28 AM
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(0)
Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies
D. Geng
,
G. Shankar
,
A. Schantz
,
M. Rajadhyaksha
,
H. Davis
, and
C. Wagner
J.Pharm.Biomed.Anal.
39(3-4):364-375
(
2005
)
to
Animals
Antibodies
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Chemistry
Drug
Enzyme-Linked
Humans
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Industry
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protein
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kanefendt
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Feb 5, 2010, 11:28 AM
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(0)
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
B. DeSilva
,
W. Smith
,
R. Weiner
,
M. Kelley
,
J. Smolec
,
B. Lee
,
M. Khan
,
R. Tacey
,
H. Hill
, and
A. Celniker
Pharm.Res.
20(11):1885-1900
(
2003
)
to
Assay
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Carrier
Europe
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kanefendt
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Feb 5, 2010, 11:28 AM
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