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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
Vascular endothelial growth factor receptor 3 is involved in tumor angiogenesis and growth
P. Laakkonen
,
M. Waltari
,
T. Holopainen
,
T. Takahashi
,
B. Pytowski
,
P. Steiner
,
D. Hicklin
,
K. Persaud
,
J. R. Tonra
,
L. Witte
, and
K. Alitalo
.
Cancer Res.
67(2):593-599
(
2007
)
P. Laakkonen
,
M. Waltari
,
T. Holopainen
,
T. Takahashi
,
B. Pytowski
,
P. Steiner
,
D. Hicklin
,
K. Persaud
,
J. R. Tonra
,
L. Witte
, and
K. Alitalo
.
Cancer Res.
67(2):593-599
(
2007
)
3 years and 4 months ago
by
kanefendt
1
&
Animals
Antibodies
Antitumor
Assays
BALB
Binding
C
Cell
D
Endothelial
Factor
Growth
Human
Humans
Immunohistochemistry
Inbred
Ligands
Mice
Model
Monoclonal
Neoplasms
Neovascularization
Nude
Pathologic
Processes
Receptor-3
Research
Vascular
Xenograft
analysis
antagonists
blood
immunology
inhibitors
metabolism
pharmacology
supply
therapy
&
Animals
Antibodies
Antitumor
Assays
BALB
Binding
C
Cell
D
Endothelial
Factor
Growth
Human
Humans
Immunohistochemistry
Inbred
Ligands
Mice
Model
Monoclonal
Neoplasms
Neovascularization
Nude
Pathologic
Processes
Receptor-3
Research
Vascular
Xenograft
analysis
antagonists
blood
immunology
inhibitors
metabolism
pharmacology
supply
therapy
(0)
URL
DOI
TeX
Molecular mechanisms of lymphatic vascular development
T. Makinen
,
C. Norrmen
, and
T. V. Petrova
.
Cell Mol.Life Sci.
64(15):1915-1929
(
2007
)
T. Makinen
,
C. Norrmen
, and
T. V. Petrova
.
Cell Mol.Life Sci.
64(15):1915-1929
(
2007
)
3 years and 4 months ago
by
kanefendt
1
A
Angiopoietins
Animals
Biological
Cells
Cultured
Endothelial
Factor
Growth
Human
Humans
Inflammation
Lymphangiogenesis
Lymphatic
Lymphedema
Models
Proteins
Receptors
Research
Substances
TIE
Transport
Vascular
Vesicular
Vessels
analysis
cells
cytology
physiology
protein
A
Angiopoietins
Animals
Biological
Cells
Cultured
Endothelial
Factor
Growth
Human
Humans
Inflammation
Lymphangiogenesis
Lymphatic
Lymphedema
Models
Proteins
Receptors
Research
Substances
TIE
Transport
Vascular
Vesicular
Vessels
analysis
cells
cytology
physiology
protein
(0)
URL
DOI
TeX
The biology of epidermal growth factor receptor and its value as a prognostic/predictive factor
A. P. Dei Tos
.
Int.J.Biol.Markers
22(1 Suppl 4):S3-S9
(
2007
)
A. P. Dei Tos
.
Int.J.Biol.Markers
22(1 Suppl 4):S3-S9
(
2007
)
3 years and 4 months ago
by
kanefendt
1
Antibodies
Biological
Epidermal
Expression
Factor
Gene
Growth
Human
Humans
Immunohistochemistry
Markers
Monoclonal
Neoplasms
Neoplastic
Prognosis
Receptor
Regulation
Tyrosine
analysis
drug
effects
etiology
identify
pathology
physiology
response
therapeutic
therapy
use
Antibodies
Biological
Epidermal
Expression
Factor
Gene
Growth
Human
Humans
Immunohistochemistry
Markers
Monoclonal
Neoplasms
Neoplastic
Prognosis
Receptor
Regulation
Tyrosine
analysis
drug
effects
etiology
identify
pathology
physiology
response
therapeutic
therapy
use
(0)
URL
DOI
TeX
Surrogate predictive biomarkers for response to anti-EGFR agents: state of the art and challenges
F. Cappuzzo
,
L. Toschi
,
G. Finocchiaro
,
C. Ligorio
, and
A. Santoro
.
Int.J.Biol.Markers
22(1 Suppl 4):S10-S23
(
2007
)
F. Cappuzzo
,
L. Toschi
,
G. Finocchiaro
,
C. Ligorio
, and
A. Santoro
.
Int.J.Biol.Markers
22(1 Suppl 4):S10-S23
(
2007
)
3 years and 4 months ago
by
kanefendt
2
&
Antibodies
Biological
Carcinoma
Dosage
Drug
Epidermal
Factor
Gene
Growth
Human
Humans
Immunohistochemistry
Inhibitors
Kinase
Kinases
Lung
Markers
Monoclonal
Mutation
Neoplasm
Neoplasms
Non-Small-Cell
Phosphoproteins
Predictive
Protein
Protein-Tyrosine
Proteins
Proto-Oncogene
Quinazolines
Receptor
Resistance
Tests
Tyrosine
Value
analysis
antagonists
c-akt
drug
effects
erbB-2
erbB-3
genetics
identify
inhibitors
of
protein
response
therapeutic
therapy
use
&
Antibodies
Biological
Carcinoma
Dosage
Drug
Epidermal
Factor
Gene
Growth
Human
Humans
Immunohistochemistry
Inhibitors
Kinase
Kinases
Lung
Markers
Monoclonal
Mutation
Neoplasm
Neoplasms
Non-Small-Cell
Phosphoproteins
Predictive
Protein
Protein-Tyrosine
Proteins
Proto-Oncogene
Quinazolines
Receptor
Resistance
Tests
Tyrosine
Value
analysis
antagonists
c-akt
drug
effects
erbB-2
erbB-3
genetics
identify
inhibitors
of
protein
response
therapeutic
therapy
use
(0)
URL
DOI
TeX
Circulating protein biomarkers of pharmacodynamic activity of sunitinib in patients with metastatic renal cell carcinoma: modulation of VEGF and VEGF-related proteins
Samuel Deprimo
,
Carlo Bello
,
John Smeraglia
,
Charles Baum
,
Dominic Spinella
,
Brian Rini
,
M. Dror Michaelson
, and
Robert Motzer
.
Journal of Translational Medicine
5(1):32
(
2007
)
Samuel Deprimo
,
Carlo Bello
,
John Smeraglia
,
Charles Baum
,
Dominic Spinella
,
Brian Rini
,
M. Dror Michaelson
, and
Robert Motzer
.
Journal of Translational Medicine
5(1):32
(
2007
)
3 years and 4 months ago
by
kanefendt
1
Carcinoma
Disease
Placenta
Progression
Proteins
Tyrosine
analysis
protein
response
therapy
Carcinoma
Disease
Placenta
Progression
Proteins
Tyrosine
analysis
protein
response
therapy
(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
Vascular endothelial growth factor-D and its receptor VEGFR-3: two novel independent prognostic markers in gastric adenocarcinoma
S. Juttner
,
C. Wissmann
,
T. Jons
,
M. Vieth
,
J. Hertel
,
S. Gretschel
,
P. M. Schlag
,
W. Kemmner
, and
M. Hocker
.
J.Clin.Oncol.
24(2):228-240
(
2006
)
S. Juttner
,
C. Wissmann
,
T. Jons
,
M. Vieth
,
J. Hertel
,
S. Gretschel
,
P. M. Schlag
,
W. Kemmner
, and
M. Hocker
.
J.Clin.Oncol.
24(2):228-240
(
2006
)
3 years and 4 months ago
by
kanefendt
1
80
Adenocarcinoma
Adult
Aged
Antibodies
C
Cell
Chemistry
D
Disease-Free
Endothelial
Factor
Growth
Humans
Immunohistochemistry
Laboratories
Line
Lymphatic
Messenger
Metastasis
Middle
Neoplasms
Prognosis
RNA
Receptor-3
Research
Stomach
Survival
Tumor
Vascular
analysis
and
blood
genetics
identify
methods
mortality
over
supply
80
Adenocarcinoma
Adult
Aged
Antibodies
C
Cell
Chemistry
D
Disease-Free
Endothelial
Factor
Growth
Humans
Immunohistochemistry
Laboratories
Line
Lymphatic
Messenger
Metastasis
Middle
Neoplasms
Prognosis
RNA
Receptor-3
Research
Stomach
Survival
Tumor
Vascular
analysis
and
blood
genetics
identify
methods
mortality
over
supply
(0)
URL
DOI
TeX
Fit-for-purpose method development and validation for successful biomarker measurement
J. W. Lee
,
V. Devanarayan
,
Y. C. Barrett
,
R. Weiner
,
J. Allinson
,
S. Fountain
,
S. Keller
,
I. Weinryb
,
M. Green
,
L. Duan
,
J. A. Rogers
,
R. Millham
,
P. J. O'Brien
,
J. Sailstad
,
M. Khan
,
C. Ray
, and
J. A. Wagner
.
Pharm.Res.
23(2):312-328
(
2006
)
J. W. Lee
,
V. Devanarayan
,
Y. C. Barrett
,
R. Weiner
,
J. Allinson
,
S. Fountain
,
S. Keller
,
I. Weinryb
,
M. Green
,
L. Duan
,
J. A. Rogers
,
R. Millham
,
P. J. O'Brien
,
J. Sailstad
,
M. Khan
,
C. Ray
, and
J. A. Wagner
.
Pharm.Res.
23(2):312-328
(
2006
)
3 years and 4 months ago
by
kanefendt
1
Approval
Biological
Calibration
Chemistry
Control
Data
Design
Drug
Interpretation
Markers
Models
Quality
Reproducibility
Research
Results
Statistical
Terminology
Topic
analysis
as
of
Approval
Biological
Calibration
Chemistry
Control
Data
Design
Drug
Interpretation
Markers
Models
Quality
Reproducibility
Research
Results
Statistical
Terminology
Topic
analysis
as
of
(0)
URL
DOI
TeX
Isolation and enumeration of circulating endothelial cells by immunomagnetic isolation: proposal of a definition and a consensus protocol
A. Woywodt
,
A. D. Blann
,
T. Kirsch
,
U. Erdbruegger
,
N. Banzet
,
M. Haubitz
, and
F. gnat George
.
J.Thromb.Haemost.
4(3):671-677
(
2006
)
A. Woywodt
,
A. D. Blann
,
T. Kirsch
,
U. Erdbruegger
,
N. Banzet
,
M. Haubitz
, and
F. gnat George
.
J.Thromb.Haemost.
4(3):671-677
(
2006
)
3 years and 4 months ago
by
kanefendt
1
Antigens
CD146
Cell
Cells
Chemistry
Count
Diseases
Endothelial
Humans
Immunomagnetic
Immunophenotyping
Lectins
Plant
Reproducibility
Results
Separation
Size
Vascular
analysis
cells
immunology
methods
of
pathology
Antigens
CD146
Cell
Cells
Chemistry
Count
Diseases
Endothelial
Humans
Immunomagnetic
Immunophenotyping
Lectins
Plant
Reproducibility
Results
Separation
Size
Vascular
analysis
cells
immunology
methods
of
pathology
(0)
URL
DOI
TeX
Analysis of recent pharmaceutical regulatory documents on analytical method validation
Rozet E
,
Ceccaco A
,
Hubert C
,
Ziemans E
,
Oprean R
,
Rudaz S
,
Boulanger B
, and
Hubert P
.
(
2007
)
Rozet E
,
Ceccaco A
,
Hubert C
,
Ziemans E
,
Oprean R
,
Rudaz S
,
Boulanger B
, and
Hubert P
.
(
2007
)
3 years and 4 months ago
by
kanefendt
1
analysis
analysis
(0)
URL
DOI
TeX
Effect of treatment with sunitinib malate, a multitargeted tyrosine kinase inhibitor, on circulating plasma levels of VEGF, soluble VEGF receptors 2 and 3, and soluble KIT in patients with metastatic breast cancer
S. E. Deprimo
,
C. Friece
,
X. Huang
,
J. Smeraglia
,
L. Sherman
,
M. Collier
,
C. Baum
,
A. D. Elias
,
H. J. Burstein
, and
K. D. Miller
.
J Clin Oncol Meeting Abstracts
24(18_suppl):578
(
2006
)
S. E. Deprimo
,
C. Friece
,
X. Huang
,
J. Smeraglia
,
L. Sherman
,
M. Collier
,
C. Baum
,
A. D. Elias
,
H. J. Burstein
, and
K. D. Miller
.
J Clin Oncol Meeting Abstracts
24(18_suppl):578
(
2006
)
3 years and 4 months ago
by
kanefendt
1
Outcome
Proteins
Research
SU11248
Treatment
Tyrosine
analysis
methods
protein
response
therapy
Outcome
Proteins
Research
SU11248
Treatment
Tyrosine
analysis
methods
protein
response
therapy
(0)
URL
DOI
TeX
The single-step method of RNA isolation by acid guanidinium thiocyanate-phenol-chloroform extraction: twenty-something years on
P. Chomczynski
, and
N. Sacchi
.
Nat.Protoc.
1(2):581-585
(
2006
)
P. Chomczynski
, and
N. Sacchi
.
Nat.Protoc.
1(2):581-585
(
2006
)
3 years and 4 months ago
by
kanefendt
1
&
Chemistry
Chloroform
Concentration
Dna
Expression
Gene
Guanidines
Hydrogen-Ion
Phenol
Proteins
RNA
Research
Thiocyanates
analysis
cells
isolation
protein
purification
&
Chemistry
Chloroform
Concentration
Dna
Expression
Gene
Guanidines
Hydrogen-Ion
Phenol
Proteins
RNA
Research
Thiocyanates
analysis
cells
isolation
protein
purification
(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
Biomarker method validation in anticancer drug development
J. Cummings
,
T. H. Ward
,
A. Greystoke
,
M. Ranson
, and
C. Dive
.
Br.J.Pharmacol.
153(4):646-656
(
2008
)
J. Cummings
,
T. H. Ward
,
A. Greystoke
,
M. Ranson
, and
C. Dive
.
Br.J.Pharmacol.
153(4):646-656
(
2008
)
3 years and 4 months ago
by
kanefendt
1
&
Adherence
Agents
Animals
Antineoplastic
Assay
Biomarkers
Cell
Clinical
Control
Death
Drug
Enzyme-Linked
Europe
Evaluation
Guideline
Guidelines
Humans
Immunosorbent
Keratin-18
Laboratories
Mass
Pharmacological
Preclinical
Proteins
Quality
Reproducibility
Research
Results
Spectrometry
Terminology
Topic
Trials
analysis
as
drug
effects
jurisprudence
legislation
methods
of
pharmacology
protein
standards
therapeutic
use
&
Adherence
Agents
Animals
Antineoplastic
Assay
Biomarkers
Cell
Clinical
Control
Death
Drug
Enzyme-Linked
Europe
Evaluation
Guideline
Guidelines
Humans
Immunosorbent
Keratin-18
Laboratories
Mass
Pharmacological
Preclinical
Proteins
Quality
Reproducibility
Research
Results
Spectrometry
Terminology
Topic
Trials
analysis
as
drug
effects
jurisprudence
legislation
methods
of
pharmacology
protein
standards
therapeutic
use
(0)
URL
DOI
TeX
Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane
H. J. Burstein
,
A. D. Elias
,
H. S. Rugo
,
M. A. Cobleigh
,
A. C. Wolff
,
P. D. Eisenberg
,
M. Lehman
,
B. J. Adams
,
C. L. Bello
,
S. E. Deprimo
,
C. M. Baum
, and
K. D. Miller
.
J Clin Oncol
26(11):1810-1816
(
2008
)
H. J. Burstein
,
A. D. Elias
,
H. S. Rugo
,
M. A. Cobleigh
,
A. C. Wolff
,
P. D. Eisenberg
,
M. Lehman
,
B. J. Adams
,
C. L. Bello
,
S. E. Deprimo
,
C. M. Baum
, and
K. D. Miller
.
J Clin Oncol
26(11):1810-1816
(
2008
)
3 years and 4 months ago
by
kanefendt
1
&
Administration
Adult
Aged
Agents
Anthracyclines
Antineoplastic
Biological
Breast
Bridged
Carcinoma
Chemotherapy
Combined
Compounds
Diseases
Drug
Fatigue
Female
Gastrointestinal
Growth
Hematologic
Humans
Indoles
Inflammation
Kinase
Kinases
Markers
Middle
Neoplasms
Oral
Plasma
Protein-Tyrosine
Protocols
Pyrroles
Rate
Schedule
Survival
Taxoids
Tumor
Tyrosine
administration
adverse
analysis
antagonists
blood
chemically
classification
dosage
drug
effects
induced
inhibitors
methods
mortality
response
secondary
therapeutic
therapy
use
&
Administration
Adult
Aged
Agents
Anthracyclines
Antineoplastic
Biological
Breast
Bridged
Carcinoma
Chemotherapy
Combined
Compounds
Diseases
Drug
Fatigue
Female
Gastrointestinal
Growth
Hematologic
Humans
Indoles
Inflammation
Kinase
Kinases
Markers
Middle
Neoplasms
Oral
Plasma
Protein-Tyrosine
Protocols
Pyrroles
Rate
Schedule
Survival
Taxoids
Tumor
Tyrosine
administration
adverse
analysis
antagonists
blood
chemically
classification
dosage
drug
effects
induced
inhibitors
methods
mortality
response
secondary
therapeutic
therapy
use
(0)
URL
DOI
TeX
EGFR FISH versus mutation: different tests, different end-points
F. Cappuzzo
.
Lung Cancer
60(2):160-165
(
2008
)
F. Cappuzzo
.
Lung Cancer
60(2):160-165
(
2008
)
3 years and 4 months ago
by
kanefendt
1
&
Analysis
Carcinoma
Clinical
DNA
Drug
Epidermal
Factor
Fluorescence
Growth
Humans
Hybridization
In
Inhibitors
Kinase
Lung
Mutation
Mutational
Neoplasm
Neoplasms
Non-Small-Cell
Patient
Population
Protein
Receptor
Resistance
Selection
Situ
Topic
Trials
Tyrosine
analysis
antagonists
as
drug
genetics
identify
inhibitors
protein
response
therapeutic
therapy
use
&
Analysis
Carcinoma
Clinical
DNA
Drug
Epidermal
Factor
Fluorescence
Growth
Humans
Hybridization
In
Inhibitors
Kinase
Lung
Mutation
Mutational
Neoplasm
Neoplasms
Non-Small-Cell
Patient
Population
Protein
Receptor
Resistance
Selection
Situ
Topic
Trials
Tyrosine
analysis
antagonists
as
drug
genetics
identify
inhibitors
protein
response
therapeutic
therapy
use
(0)
URL
DOI
TeX
How well do angiogenesis inhibitors work? Biomarkers of response prove elusive
V. Brower
.
J.Natl.Cancer Inst.
101(12):846-847
(
2009
)
V. Brower
.
J.Natl.Cancer Inst.
101(12):846-847
(
2009
)
3 years and 4 months ago
by
kanefendt
1
A
Analysis
Angiogenesis
Animals
Antibodies
Benzenesulfonates
Biological
Cells
Cytokines
Disease-Free
Endothelial
Factor
Growth
Humans
Indoles
Inhibitors
Markers
Monoclonal
Neoplasms
Pyridines
Pyrroles
Survival
Tumor
Vascular
blood
drug
effects
metabolism
mortality
pathology
pharmacology
response
supply
therapeutic
therapy
use
A
Analysis
Angiogenesis
Animals
Antibodies
Benzenesulfonates
Biological
Cells
Cytokines
Disease-Free
Endothelial
Factor
Growth
Humans
Indoles
Inhibitors
Markers
Monoclonal
Neoplasms
Pyridines
Pyrroles
Survival
Tumor
Vascular
blood
drug
effects
metabolism
mortality
pathology
pharmacology
response
supply
therapeutic
therapy
use
(0)
URL
DOI
TeX
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