Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development (Q37462448)

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scientific article published on May 2009

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English	Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development	scientific article published on May 2009

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scholarly article

1 reference

Europe PubMed Central

20 August 2017

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Europe PubMed Central

Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development (English)

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Europe PubMed Central

20 August 2017

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pathophysiology

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based on heuristic

inferred from title

author name string

M A Karsdal

1

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Europe PubMed Central

20 August 2017

K Henriksen

2

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Europe PubMed Central

20 August 2017

D J Leeming

3

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Europe PubMed Central

20 August 2017

P Mitchell

4

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Europe PubMed Central

20 August 2017

K Duffin

5

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Europe PubMed Central

20 August 2017

N Barascuk

6

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Europe PubMed Central

20 August 2017

L Klickstein

7

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Europe PubMed Central

20 August 2017

P Aggarwal

8

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Europe PubMed Central

20 August 2017

O Nemirovskiy

9

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Europe PubMed Central

20 August 2017

I Byrjalsen

10

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Europe PubMed Central

20 August 2017

P Qvist

11

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Europe PubMed Central

20 August 2017

A C Bay-Jensen

12

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Europe PubMed Central

20 August 2017

E B Dam

13

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Europe PubMed Central

20 August 2017

S H Madsen

14

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Europe PubMed Central

20 August 2017

C Christiansen

15

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Europe PubMed Central

20 August 2017

language of work or name

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based on heuristic

inferred from title

publication date

1 May 2009

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Europe PubMed Central

20 August 2017

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Europe PubMed Central

20 August 2017

14

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Europe PubMed Central

20 August 2017

181-202

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Europe PubMed Central

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3

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Europe PubMed Central

20 August 2017

Serum levels of cartilage oligomeric matrix protein (COMP) increase temporarily after physical exercise in patients with knee osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Enzymic and non-enzymic cross-linking mechanisms in relation to turnover of collagen: relevance to aging and exercise

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Oral salmon calcitonin induced suppression of urinary collagen type II degradation in postmenopausal women: a new potential treatment of osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Mechanisms of maturation and ageing of collagen

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Isolation and structural identification of a labile intermolecular crosslink in collagen.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Defective collagen crosslinking in bone, but not in ligament or cartilage, in Bruck syndrome: indications for a bone-specific telopeptide lysyl hydroxylase on chromosome 17.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Classification of osteoarthritis biomarkers: a proposed approach.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Biochemical changes in articular cartilage after joint immobilization by casting or external fixation

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Risedronate decreases biochemical markers of cartilage degradation but does not decrease symptoms or slow radiographic progression in patients with medial compartment osteoarthritis of the knee: results of the two-year multinational knee osteoarthri

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Changes in serum cartilage marker levels indicate altered cartilage metabolism in families with the osteoarthritis-related type II collagen gene COL2A1 mutation

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

A 2 yr longitudinal radiographic study examining the effect of a bisphosphonate (risedronate) upon subchondral bone loss in osteoarthritic knee patients

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Serum CrossLaps for monitoring the response in individuals undergoing antiresorptive therapy.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Suppression of elevated cartilage turnover in postmenopausal women and in ovariectomized rats by estrogen and a selective estrogen-receptor modulator (SERM).

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Bone turnover in postmenopausal osteoporosis. Effect of calcitonin treatment

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

ADAMTS-8 exhibits aggrecanase activity and is expressed in human articular cartilage

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Meta-analyses of therapies for postmenopausal osteoporosis. VI. Meta-analysis of calcitonin for the treatment of postmenopausal osteoporosis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Serum cartilage oligomeric matrix protein (COMP) decreases in rheumatoid arthritis patients treated with infliximab or etanercept

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Evidence for metalloproteinase and metalloproteinase inhibitor imbalance in human osteoarthritic cartilage

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Hormone replacement therapy in the prevention and treatment of osteoporosis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Segmenting articular cartilage automatically using a voxel classification approach.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Clinical biomarkers in drug discovery and development

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Relationships between biochemical markers of bone and cartilage degradation with radiological progression in patients with knee osteoarthritis receiving risedronate: the Knee Osteoarthritis Structural Arthritis randomized clinical trial.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The type I collagen fragments ICTP and CTX reveal distinct enzymatic pathways of bone collagen degradation.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Markers of bone resorption predict hip fracture in elderly women: the EPIDOS Prospective Study

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Deletion of active ADAMTS5 prevents cartilage degradation in a murine model of osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Early changes in biochemical markers of bone turnover predict the long-term response to alendronate therapy in representative elderly women: a randomized clinical trial

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Transgenic mouse models for studying the role of cartilage macromolecules in osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Osteoclasts from patients with autosomal dominant osteopetrosis type I caused by a T253I mutation in low-density lipoprotein receptor-related protein 5 are normal in vitro, but have decreased resorption capacity in vivo

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Characterization of osteoclasts from patients harboring a G215R mutation in ClC-7 causing autosomal dominant osteopetrosis type II

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Assessment of osteoclast number and function: application in the development of new and improved treatment modalities for bone diseases

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Ovariectomized rats as a model of postmenopausal osteoarthritis: validation and application

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Modern biomedical research: an internally self-consistent universe with little contact with medical reality?

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. Early Postmenopausal Intervention Cohort Study Group.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Characterization of novel cathepsin K mutations in the pro and mature polypeptide regions causing pycnodysostosis.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Oncostatin M in combination with tumor necrosis factor alpha induces cartilage damage and matrix metalloproteinase expression in vitro and in vivo.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The effects of oral calcitonin on bone collagen maturation: implications for bone turnover and quality.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Optimizing bioavailability of oral administration of small peptides through pharmacokinetic and pharmacodynamic parameters: the effect of water and timing of meal intake on oral delivery of Salmon Calcitonin

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Acidification of the osteoclastic resorption compartment provides insight into the coupling of bone formation to bone resorption.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Should subchondral bone turnover be targeted when treating osteoarthritis?

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Cartilage degradation is fully reversible in the presence of aggrecanase but not matrix metalloproteinase activity

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Are nonresorbing osteoclasts sources of bone anabolic activity?

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Osteoclasts secrete non-bone derived signals that induce bone formation.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Optimising antiresorptive therapies in postmenopausal women: why do we need to give due consideration to the degree of suppression?

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Induction of increased cAMP levels in articular chondrocytes blocks matrix metalloproteinase-mediated cartilage degradation, but not aggrecanase-mediated cartilage degradation.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Radiological assessment of osteo-arthrosis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Molecular basis of osteoarthritis: biomechanical aspects

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Structure and function of aggrecan

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Early changes in biochemical markers of bone turnover predict bone mineral density response to antiresorptive therapy in Korean postmenopausal women with osteoporosis.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Cytokine regulation of cartilage-derived retinoic acid-sensitive protein (CD-RAP) in primary articular chondrocytes: suppression by IL-1, bfGF, TGFbeta and stimulation by IGF-1.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The modulation of matrix metalloproteinase and ADAM gene expression in human chondrocytes by interleukin-1 and oncostatin M: a time-course study using real-time quantitative reverse transcription-polymerase chain reaction

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Biomarkers and surrogate endpoints: how and when might they impact drug development?

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

An update on biomarkers of bone turnover and their utility in biomedical research and clinical practice

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Matrix metalloproteinases are not essential for aggrecan turnover during normal skeletal growth and development

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Release of cartilage oligomeric matrix protein (COMP) into joint fluid after knee injury and in osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Cytokines and their role in the pathophysiology of osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Denosumab in postmenopausal women with low bone mineral density

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Use of thiazolidinediones and fracture risk

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Identification, expression, and tissue distribution of the three rat lysyl hydroxylase isoforms

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Diabetes drug pioglitazone (Actos): risk of fracture

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Cartilage turnover assessed with a newly developed assay measuring collagen type II degradation products: influence of age, sex, menopause, hormone replacement therapy, and body mass index

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Reappraising metalloproteinases in rheumatoid arthritis and osteoarthritis: destruction or repair?

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Discovery and development of a type II collagen neoepitope (TIINE) biomarker for matrix metalloproteinase activity: from in vitro to in vivo.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Discovery and development of the N-terminal procollagen type II (NPII) biomarker: a tool for measuring collagen type II synthesis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Determination of bone markers in pycnodysostosis: effects of cathepsin K deficiency on bone matrix degradation.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The utility of measuring C-terminal telopeptides of collagen type II (CTX-II) in serum and synovial fluid samples for estimation of articular cartilage status in experimental models of destructive joint diseases.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Significance of serum CrossLaps as a predictor of changes in bone mineral density during estrogen replacement therapy; comparison with serum carboxyterminal telopeptide of type I collagen and urinary deoxypyridinoline

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

New drugs for rheumatoid arthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The inhibition of subchondral bone resorption in the early phase of experimental dog osteoarthritis by licofelone is associated with a reduction in the synthesis of MMP-13 and cathepsin K.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Biological markers in rheumatoid arthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Molecular pharmacology of the calcitonin receptor

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Separation of healthy and early osteoarthritis by automatic quantification of cartilage homogeneity

1 reference

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21 January 2018

The disease modifying osteoarthritis drug (DMOAD): Is it in the horizon?

1 reference

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21 January 2018

Immunoaffinity liquid chromatography-tandem mass spectrometry detection of nitrotyrosine in biological fluids: development of a clinically translatable biomarker

1 reference

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21 January 2018

Biochemical markers for prediction of 4-year response in bone mass during bisphosphonate treatment for prevention of postmenopausal osteoporosis.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The new collagenase, collagenase-3, is expressed and synthesized by human chondrocytes but not by synoviocytes. A role in osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Bone remodeling increases substantially in the years after menopause and remains increased in older osteoporosis patients

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Therapeutic approaches to bone diseases

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Cell biology of the osteoclast

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Biological markers in osteoarthritis

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Serum levels of type IIA procollagen amino terminal propeptide (PIIANP) are decreased in patients with knee osteoarthritis and rheumatoid arthritis.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Relationship between changes in biochemical markers of bone turnover and BMD to predict vertebral fracture risk

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

In vitro, ex vivo, and in vivo methodological approaches for studying therapeutic targets of osteoporosis and degenerative joint diseases: how biomarkers can assist?

1 reference

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21 January 2018

The role of chloride channels in osteoclasts: ClC-7 as a target for osteoporosis treatment

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

The chloride channel inhibitor NS3736 [corrected] prevents bone resorption in ovariectomized rats without changing bone formation.

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Bone quality--the material and structural basis of bone strength and fragility

1 reference

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21 January 2018

Fracture risk is a class effect of glitazones

1 reference

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21 January 2018

Diphyllin, a novel and naturally potent V-ATPase inhibitor, abrogates acidification of the osteoclastic resorption lacunae and bone resorption

1 reference

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21 January 2018

Effect of risedronate on joint structure and symptoms of knee osteoarthritis: results of the BRISK randomized, controlled trial [ISRCTN01928173]

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Development and application of a serum C-telopeptide and osteocalcin assay to measure bone turnover in an ovariectomized rat model

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

ADAMTS5 is the major aggrecanase in mouse cartilage in vivo and in vitro

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Application of biomarkers in the clinical development of new drugs for chondroprotection in destructive joint diseases: a review

1 reference

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21 January 2018

ADAMTS: a novel family of extracellular matrix proteases

1 reference

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21 January 2018

Safety and efficacy of a novel salmon calcitonin (sCT) technology-based oral formulation in healthy postmenopausal women: acute and 3-month effects on biomarkers of bone turnover

1 reference

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21 January 2018

Lessons from animal models of arthritis

1 reference

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21 January 2018

Overview of biomarkers and surrogate endpoints in drug development

1 reference

https://api.crossref.org/works/10.1080%2F13547500902777608

21 January 2018

Turnover of type II collagen and aggrecan in cartilage matrix at the onset of inflammatory arthritis in humans: Relationship to mediators of systemic and local inflammation

1 reference

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21 January 2018

Early changes in serum type ii collagen biomarkers predict radiographic progression at one year in inflammatory arthritis patients after biologic therapy

1 reference

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21 January 2018

Identifiers

10.1080/13547500902777608

1 reference

Europe PubMed Central

20 August 2017

1 reference

Europe PubMed Central

20 August 2017

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