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Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part II
P. Hubert
,
J. J. Nguyen-Huu
,
B. Boulanger
,
E. Chapuzet
,
P. Chiap
,
N. Cohen
,
P. A. Compagnon
,
W. Dewe
,
M. Feinberg
,
M. Lallier
,
M. Laurentie
,
N. Mercier
,
G. Muzard
,
C. Nivet
,
L. Valat
, and
E. Rozet
.
J.Pharm.Biomed.Anal.
45(1):70-81
(
2007
)
P. Hubert
,
J. J. Nguyen-Huu
,
B. Boulanger
,
E. Chapuzet
,
P. Chiap
,
N. Cohen
,
P. A. Compagnon
,
W. Dewe
,
M. Feinberg
,
M. Lallier
,
M. Laurentie
,
N. Mercier
,
G. Muzard
,
C. Nivet
,
L. Valat
, and
E. Rozet
.
J.Pharm.Biomed.Anal.
45(1):70-81
(
2007
)
3 years and 4 months ago
by
kanefendt
1
Analytical
Calibration
Chemistry
Clinical
France
Laboratories
Laboratory
Medical
Pharmaceutical
Reference
Reproducibility
Research
Results
Societies
Standards
Techniques
methods
of
standards
Analytical
Calibration
Chemistry
Clinical
France
Laboratories
Laboratory
Medical
Pharmaceutical
Reference
Reproducibility
Research
Results
Societies
Standards
Techniques
methods
of
standards
(0)
URL
DOI
TeX
Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III
P. Hubert
,
J. J. Nguyen-Huu
,
B. Boulanger
,
E. Chapuzet
,
N. Cohen
,
P. A. Compagnon
,
W. Dewe
,
M. Feinberg
,
M. Laurentie
,
N. Mercier
,
G. Muzard
,
L. Valat
, and
E. Rozet
.
J.Pharm.Biomed.Anal.
45(1):82-96
(
2007
)
P. Hubert
,
J. J. Nguyen-Huu
,
B. Boulanger
,
E. Chapuzet
,
N. Cohen
,
P. A. Compagnon
,
W. Dewe
,
M. Feinberg
,
M. Laurentie
,
N. Mercier
,
G. Muzard
,
L. Valat
, and
E. Rozet
.
J.Pharm.Biomed.Anal.
45(1):82-96
(
2007
)
3 years and 4 months ago
by
kanefendt
1
&
Analytical
Calibration
Chemistry
Clinical
France
Laboratories
Laboratory
Medical
Pharmaceutical
Reference
Reproducibility
Research
Results
Societies
Standards
Techniques
data
methods
numerical
of
standards
statistics
&
Analytical
Calibration
Chemistry
Clinical
France
Laboratories
Laboratory
Medical
Pharmaceutical
Reference
Reproducibility
Research
Results
Societies
Standards
Techniques
data
methods
numerical
of
standards
statistics
(0)
URL
DOI
TeX
Key elements of bioanalytical method validation for macromolecules
M. Kelley
, and
B. DeSilva
.
AAPS.J.
9(2):E156-E163
(
2007
)
M. Kelley
, and
B. DeSilva
.
AAPS.J.
9(2):E156-E163
(
2007
)
3 years and 4 months ago
by
kanefendt
1
Antibodies
Binding
Chemistry
Immunoassay
Indicators
Ligands
Macromolecular
Monoclonal
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reference
Reproducibility
Results
Sensitivity
Specificity
Standards
Substances
analysis
and
metabolism
methods
of
standards
Antibodies
Binding
Chemistry
Immunoassay
Indicators
Ligands
Macromolecular
Monoclonal
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reference
Reproducibility
Results
Sensitivity
Specificity
Standards
Substances
analysis
and
metabolism
methods
of
standards
(0)
URL
DOI
TeX
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
)
W. Nowatzke
, and
E. Woolf
.
AAPS.J.
9(2):E117-E122
(
2007
)
3 years and 4 months ago
by
kanefendt
1
Animals
Binding
Biopharmaceutics
Chemistry
Control
Drug
Humans
Pharmaceutical
Pharmacokinetics
Preparations
Quality
Reference
Reproducibility
Results
Solutions
Stability
Standards
analysis
deficiency
metabolism
methods
of
standards
Animals
Binding
Biopharmaceutics
Chemistry
Control
Drug
Humans
Pharmaceutical
Pharmacokinetics
Preparations
Quality
Reference
Reproducibility
Results
Solutions
Stability
Standards
analysis
deficiency
metabolism
methods
of
standards
(0)
URL
DOI
TeX
Appropriate calibration curve fitting in ligand binding assays
J. W. Findlay
, and
R. F. Dillard
.
AAPS.J.
9(2):E260-E267
(
2007
)
J. W. Findlay
, and
R. F. Dillard
.
AAPS.J.
9(2):E260-E267
(
2007
)
3 years and 4 months ago
by
kanefendt
1
&
Algorithms
Analytical
Binding
Calibration
Chemistry
Dose-Response
Drug
Ligands
Models
Pharmaceutical
Pharmacokinetics
Preparations
Protein
RANGE
Relationship
Reproducibility
Research
Results
Sensitivity
Specificity
Statistical
analysis
and
data
metabolism
methods
numerical
of
response
statistics
&
Algorithms
Analytical
Binding
Calibration
Chemistry
Dose-Response
Drug
Ligands
Models
Pharmaceutical
Pharmacokinetics
Preparations
Protein
RANGE
Relationship
Reproducibility
Research
Results
Sensitivity
Specificity
Statistical
analysis
and
data
metabolism
methods
numerical
of
response
statistics
(0)
URL
DOI
TeX
Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays
C. T. Viswanathan
,
S. Bansal
,
B. Booth
,
A. J. DeStefano
,
M. J. Rose
,
J. Sailstad
,
V. P. Shah
,
J. P. Skelly
,
P. G. Swann
, and
R. Weiner
.
Pharm.Res.
24(10):1962-1973
(
2007
)
C. T. Viswanathan
,
S. Bansal
,
B. Booth
,
A. J. DeStefano
,
M. J. Rose
,
J. Sailstad
,
V. P. Shah
,
J. P. Skelly
,
P. G. Swann
, and
R. Weiner
.
Pharm.Res.
24(10):1962-1973
(
2007
)
3 years and 4 months ago
by
kanefendt
1
&
Administration
Animals
Artifacts
Assay
Binding
Biological
Body
Calibration
Chemistry
Chromatography
Control
Documentation
Drug
Fluids
Food
Government
Guidelines
Humans
Macromolecular
Pharmaceutical
Quality
Radioligand
Reference
Regulation
Reproducibility
Research
Results
Species
Specificity
Stability
Standards
States
Substances
Technology
Topic
United
and
as
jurisprudence
legislation
methods
of
standards
&
Administration
Animals
Artifacts
Assay
Binding
Biological
Body
Calibration
Chemistry
Chromatography
Control
Documentation
Drug
Fluids
Food
Government
Guidelines
Humans
Macromolecular
Pharmaceutical
Quality
Radioligand
Reference
Regulation
Reproducibility
Research
Results
Species
Specificity
Stability
Standards
States
Substances
Technology
Topic
United
and
as
jurisprudence
legislation
methods
of
standards
(0)
URL
DOI
TeX
Critical ligand binding reagent preparation/selection: when specificity depends on reagents
B. Rup
, and
D. O'Hara
.
AAPS.J.
9(2):E148-E155
(
2007
)
B. Rup
, and
D. O'Hara
.
AAPS.J.
9(2):E148-E155
(
2007
)
3 years and 4 months ago
by
kanefendt
1
Antibodies
Binding
Chemistry
Immunoassay
Indicators
Ligands
Monoclonal
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reproducibility
Research
Results
Safety
Sensitivity
Specificity
and
metabolism
methods
of
standards
Antibodies
Binding
Chemistry
Immunoassay
Indicators
Ligands
Monoclonal
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reproducibility
Research
Results
Safety
Sensitivity
Specificity
and
metabolism
methods
of
standards
(0)
URL
DOI
TeX
Validation of analytic methods for biomarkers used in drug development
C. H. Chau
,
O. Rixe
,
H. McLeod
, and
W. D. Figg
.
Clin.Cancer Res.
14(19):5967-5976
(
2008
)
C. H. Chau
,
O. Rixe
,
H. McLeod
, and
W. D. Figg
.
Clin.Cancer Res.
14(19):5967-5976
(
2008
)
3 years and 4 months ago
by
kanefendt
1
Agents
Animals
Antineoplastic
Biological
Biomarkers
Chemistry
Design
Drug
Evaluation
Genome
Genomics
Human
Humans
Markers
Medical
Mice
Neoplasms
Oncology
Outcome
Pharmaceutical
Pharmacological
Preclinical
Research
Treatment
Tumor
analysis
drug
metabolism
methods
pharmacology
therapy
Agents
Animals
Antineoplastic
Biological
Biomarkers
Chemistry
Design
Drug
Evaluation
Genome
Genomics
Human
Humans
Markers
Medical
Mice
Neoplasms
Oncology
Outcome
Pharmaceutical
Pharmacological
Preclinical
Research
Treatment
Tumor
analysis
drug
metabolism
methods
pharmacology
therapy
(0)
URL
DOI
TeX
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
)
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
)
3 years and 4 months ago
by
kanefendt
1
Assay
Availability
Biological
Equivalency
Indicators
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reproducibility
Research
Results
Therapeutic
analysis
and
of
Assay
Availability
Biological
Equivalency
Indicators
Pharmaceutical
Pharmacokinetics
Preparations
Reagents
Reproducibility
Research
Results
Therapeutic
analysis
and
of
(0)
URL
DOI
TeX
Method validation in the bioanalytical laboratory
A. R. Buick
,
M. V. Doig
,
S. C. Jeal
,
G. S. Land
, and
R. D. McDowall
.
J.Pharm.Biomed.Anal.
8(8-12):629-637
(
1990
)
A. R. Buick
,
M. V. Doig
,
S. C. Jeal
,
G. S. Land
, and
R. D. McDowall
.
J.Pharm.Biomed.Anal.
8(8-12):629-637
(
1990
)
3 years and 4 months ago
by
kanefendt
1
Chemistry
Drug
Freezing
Mass
Pharmaceutical
Reference
Research
Solubility
Species
Specificity
Spectrometry
Stability
Standards
Temperature
instrumentation
methods
standards
Chemistry
Drug
Freezing
Mass
Pharmaceutical
Reference
Research
Solubility
Species
Specificity
Spectrometry
Stability
Standards
Temperature
instrumentation
methods
standards
(0)
URL
DOI
TeX
Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--Part I
P. Hubert
,
J. J. Nguyen-Huu
,
B. Boulanger
,
E. Chapuzet
,
P. Chiap
,
N. Cohen
,
P. A. Compagnon
,
W. Dewe
,
M. Feinberg
,
M. Lallier
,
M. Laurentie
,
N. Mercier
,
G. Muzard
,
C. Nivet
, and
L. Valat
.
J.Pharm.Biomed.Anal.
36(3):579-586
(
2004
)
P. Hubert
,
J. J. Nguyen-Huu
,
B. Boulanger
,
E. Chapuzet
,
P. Chiap
,
N. Cohen
,
P. A. Compagnon
,
W. Dewe
,
M. Feinberg
,
M. Lallier
,
M. Laurentie
,
N. Mercier
,
G. Muzard
,
C. Nivet
, and
L. Valat
.
J.Pharm.Biomed.Anal.
36(3):579-586
(
2004
)
3 years and 4 months ago
by
kanefendt
1
Analytical
Chemistry
Clinical
France
Laboratory
Medical
Pharmaceutical
Reproducibility
Results
Societies
Techniques
diagnosis
methods
of
standards
Analytical
Chemistry
Clinical
France
Laboratory
Medical
Pharmaceutical
Reproducibility
Results
Societies
Techniques
diagnosis
methods
of
standards
(0)
URL
DOI
TeX
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
)
D. Geng
,
G. Shankar
,
A. Schantz
,
M. Rajadhyaksha
,
H. Davis
, and
C. Wagner
.
J.Pharm.Biomed.Anal.
39(3-4):364-375
(
2005
)
3 years and 4 months ago
by
kanefendt
1
Animals
Antibodies
Assay
Chemistry
Drug
Enzyme-Linked
Humans
Immunoassay
Immunoenzyme
Immunosorbent
Industry
Monoclonal
Pharmaceutical
Preparations
Reproducibility
Research
Results
Sensitivity
Specificity
Techniques
analysis
and
methods
of
pharmacology
protein
Animals
Antibodies
Assay
Chemistry
Drug
Enzyme-Linked
Humans
Immunoassay
Immunoenzyme
Immunosorbent
Industry
Monoclonal
Pharmaceutical
Preparations
Reproducibility
Research
Results
Sensitivity
Specificity
Techniques
analysis
and
methods
of
pharmacology
protein
(0)
URL
DOI
TeX
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
,
R. R. Bowsher
,
D. W. Knuth
,
P. J. O'Brien
,
J. L. Fourcroy
,
R. Dixit
,
L. Pandite
,
R. G. Pietrusko
,
H. D. Soares
,
V. Quarmby
,
O. L. Vesterqvist
,
D. M. Potter
,
J. L. Witliff
,
H. A. Fritche
,
T. O'Leary
,
L. Perlee
,
S. Kadam
, and
J. A. Wagner
.
Pharm.Res.
22(4):499-511
(
2005
)
J. W. Lee
,
R. S. Weiner
,
J. M. Sailstad
,
R. R. Bowsher
,
D. W. Knuth
,
P. J. O'Brien
,
J. L. Fourcroy
,
R. Dixit
,
L. Pandite
,
R. G. Pietrusko
,
H. D. Soares
,
V. Quarmby
,
O. L. Vesterqvist
,
D. M. Potter
,
J. L. Witliff
,
H. A. Fritche
,
T. O'Leary
,
L. Perlee
,
S. Kadam
, and
J. A. Wagner
.
Pharm.Res.
22(4):499-511
(
2005
)
3 years and 4 months ago
by
kanefendt
1
Assay
Biological
Chemistry
Clinical
Markers
Pharmaceutical
Reproducibility
Research
Results
Topic
Trials
analysis
as
methods
of
standards
toxicity
trends
Assay
Biological
Chemistry
Clinical
Markers
Pharmaceutical
Reproducibility
Research
Results
Topic
Trials
analysis
as
methods
of
standards
toxicity
trends
(0)
URL
DOI
TeX
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
)
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
)
3 years and 4 months ago
by
kanefendt
1
Assay
Binding
Carrier
Europe
Ligands
Macromolecular
Pharmaceutical
Preparations
Proteins
Radioligand
Reproducibility
Research
Results
States
Substances
United
metabolism
methods
of
protein
standards
Assay
Binding
Carrier
Europe
Ligands
Macromolecular
Pharmaceutical
Preparations
Proteins
Radioligand
Reproducibility
Research
Results
States
Substances
United
metabolism
methods
of
protein
standards
(0)
URL
DOI
TeX
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