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Single‐ and Multiple‐Dose Randomized Studies of Blosozumab, a Monoclonal Antibody Against Sclerostin, in Healthy Postmenopausal Women

Journal of bone and mineral research, 2014-04, Vol.29 (4), p.935-943

2014

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Abemaciclib Inhibits Renal Tubular Secretion Without Changing Glomerular Filtration Rate

Clinical pharmacology and therapeutics, 2019-05, Vol.105 (5), p.1187-1195

2019

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Adaptively leveraging external data with robust meta‐analytical‐predictive prior using empirical Bayes

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2023-09, Vol.22 (5), p.846-860

2023

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Non-Lethal Endotoxin Injection: A Rat Model of Hypercoagulability

PloS one, 2017-01, Vol.12 (1), p.e0169976-e0169976

2017

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Abemaciclib does not increase the corrected QT interval in healthy participants

Clinical and translational science, 2023-09, Vol.16 (9), p.1617-1627

2023

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Improving the performance of Bayesian logistic regression model with overdose control in oncology dose‐finding studies

Statistics in medicine, 2022-11, Vol.41 (27), p.5463-5483

2022

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Rejoinder: Improving the performance of Bayesian logistic regression model with overdose control in oncology dose‐finding studies

Statistics in medicine, 2022-11, Vol.41 (27), p.5497-5500

2022

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The evaluation of drug-induced changes in cardiac inotropy in dogs: Results from a HESI-sponsored consortium

Journal of pharmacological and toxicological methods, 2015-09, Vol.75, p.70-90

2015

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A Randomized, Double‐Blind Phase 2 Clinical Trial of Blosozumab, a Sclerostin Antibody, in Postmenopausal Women with Low Bone Mineral Density

Journal of bone and mineral research, 2015-02, Vol.30 (2), p.216-224

2015

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On the Implementation of Robust Meta-Analytical-Predictive Prior

Statistics in biopharmaceutical research, 2022-10, Vol.14 (4), p.602-610

2022

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Incidence of vertebral fractures in calcium and vitamin D-supplemented postmenopausal Brazilian women with osteopenia or osteoporosis: data from Arzoxifene Generations Trial

Archives of Endocrinology and Metabolism, 2016-02, Vol.60 (1), p.54-59

2016

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The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density

Journal of bone and mineral research, 2015-09, Vol.30 (9), p.1717-1725

2015

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Scientific Regulatory Policy Committee Points to Consider: Nuisance Factors, Block Effects, and Batch Effects in Nonclinical Safety Assessment Studies

Toxicologic pathology, 2020-06, Vol.48 (4), p.537-548

2020

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Effects of teriparatide on cortical histomorphometric variables in postmenopausal women with or without prior alendronate treatment

Bone (New York, N.Y.), 2014-02, Vol.59, p.139-147

2014

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Use of the ZDF rat to model dietary fat induced hypercoagulability is limited by progressive and fatal nephropathy

Journal of pharmacological and toxicological methods, 2021-01, Vol.107, p.106933, Article 106933

2021

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Bayesian Semiparametric Predictive Modeling with Applications in Dose-Response Prediction

Journal of biopharmaceutical statistics, 2014-03, Vol.24 (2), p.294-309

2014

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Heartbeat dynamics in adrenergic blocker treated conscious beagle dogs

Journal of pharmacological and toxicological methods, 2008-09, Vol.58 (2), p.118-128

2008

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The evaluation of endpoint variability and implications for study statistical power and sample size in conscious instrumented dogs

Journal of pharmacological and toxicological methods, 2018-07, Vol.92, p.43-51

2018

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An evaluation of the utility of LVdP/dt40, QA interval, LVdP/dtmin and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs

Journal of pharmacological and toxicological methods, 2017-05, Vol.85, p.1-21

2017

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An evaluation of the utility of LVdP/dt 40 , QA interval, LVdP/dt min and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs

Journal of pharmacological and toxicological methods, 2017-05, Vol.85, p.1-21

2017

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Detection of Left Ventricular Hypertrophy in Rats Administered a Peroxisome Proliferator–Activated Receptor α/γ Dual Agonist Using Natriuretic Peptides and Imaging

Toxicological sciences, 2010-04, Vol.114 (2), p.183-192

2010

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Kainic Acid-induced F-344 Rat model of Mesial Temporal Lobe Epilepsy: Gene Expression and Canonical Pathways

Toxicologic pathology, 2009-10, Vol.37 (6), p.776-789

2009

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Qualification of Cardiac Troponin I Concentration in Mouse Serum Using Isoproterenol and Implementation in Pharmacology Studies to Accelerate Drug Development

Toxicologic pathology, 2009-08, Vol.37 (5), p.617-628

2009

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Utility of positive controls in assessing assay sensitivity in ICH S7B and ICH E14 guidance for evaluation of QT/QTc interval prolongation

Journal of pharmacological and toxicological methods, 2010-09, Vol.62 (2), p.143-147

2010

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Single‐ and Multiple‐Dose Randomized Studies of Blosozumab, a Monoclonal Antibody Against Sclerostin, in Healthy Postmenopausal Women

Abemaciclib Inhibits Renal Tubular Secretion Without Changing Glomerular Filtration Rate

Adaptively leveraging external data with robust meta‐analytical‐predictive prior using empirical Bayes

Non-Lethal Endotoxin Injection: A Rat Model of Hypercoagulability

Abemaciclib does not increase the corrected QT interval in healthy participants

A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER

Improving the performance of Bayesian logistic regression model with overdose control in oncology dose‐finding studies

Rejoinder: Improving the performance of Bayesian logistic regression model with overdose control in oncology dose‐finding studies

The evaluation of drug-induced changes in cardiac inotropy in dogs: Results from a HESI-sponsored consortium

A Randomized, Double‐Blind Phase 2 Clinical Trial of Blosozumab, a Sclerostin Antibody, in Postmenopausal Women with Low Bone Mineral Density

On the Implementation of Robust Meta-Analytical-Predictive Prior

Incidence of vertebral fractures in calcium and vitamin D-supplemented postmenopausal Brazilian women with osteopenia or osteoporosis: data from Arzoxifene Generations Trial

The Effect of Discontinuing Treatment With Blosozumab: Follow‐up Results of a Phase 2 Randomized Clinical Trial in Postmenopausal Women With Low Bone Mineral Density

Scientific Regulatory Policy Committee Points to Consider: Nuisance Factors, Block Effects, and Batch Effects in Nonclinical Safety Assessment Studies

Effects of teriparatide on cortical histomorphometric variables in postmenopausal women with or without prior alendronate treatment

Use of the ZDF rat to model dietary fat induced hypercoagulability is limited by progressive and fatal nephropathy

Bayesian Semiparametric Predictive Modeling with Applications in Dose-Response Prediction

Heartbeat dynamics in adrenergic blocker treated conscious beagle dogs

The evaluation of endpoint variability and implications for study statistical power and sample size in conscious instrumented dogs

An evaluation of the utility of LVdP/dt40, QA interval, LVdP/dtmin and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs

An evaluation of the utility of LVdP/dt 40 , QA interval, LVdP/dt min and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs

Detection of Left Ventricular Hypertrophy in Rats Administered a Peroxisome Proliferator–Activated Receptor α/γ Dual Agonist Using Natriuretic Peptides and Imaging

Kainic Acid-induced F-344 Rat model of Mesial Temporal Lobe Epilepsy: Gene Expression and Canonical Pathways

Qualification of Cardiac Troponin I Concentration in Mouse Serum Using Isoproterenol and Implementation in Pharmacology Studies to Accelerate Drug Development

Utility of positive controls in assessing assay sensitivity in ICH S7B and ICH E14 guidance for evaluation of QT/QTc interval prolongation

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