A comprehensive evaluation of exposure–response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis

Chuanpu Hu; Zhenling Yao; Yang Chen; Bruce Randazzo; Liping Zhang; Zhenhua Xu; Amarnath Sharma; Honghui Zhou

doi:10.1007/s10928-018-9581-1

A comprehensive evaluation of exposure–response relationships in clinical trials: application to support guselkumab dose selection for patients with psoriasis

Journal of Pharmacokinetics and Pharmacodynamics ◽

10.1007/s10928-018-9581-1 ◽

2018 ◽

Vol 45 (4) ◽

pp. 523-535 ◽

Cited By ~ 10

Author(s):

Chuanpu Hu ◽

Zhenling Yao ◽

Yang Chen ◽

Bruce Randazzo ◽

Liping Zhang ◽

...

Keyword(s):

Clinical Trials ◽

Comprehensive Evaluation ◽

Dose Selection ◽

Exposure Response ◽

Selection For

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804 EXPOSURE–RESPONSE ANALYSES OF ASUNAPREVIR IN COMBINATION WITH DACLATASVIR PEGINTERFERON/ RIBAVIRIN AMONG PATIENTS WITH GENOTYPE 1 CHRONIC HCV INFECTION: DOSE SELECTION FOR PHASE 3 CLINICAL TRIALS

Journal of Hepatology ◽

10.1016/s0168-8278(13)60806-5 ◽

2013 ◽

Vol 58 ◽

pp. S328-S329 ◽

Cited By ~ 4

Author(s):

P. Chan ◽

E. Tafoya ◽

T. Eley ◽

B. He ◽

P. Mendez ◽

...

Keyword(s):

Clinical Trials ◽

Hcv Infection ◽

Genotype 1 ◽

Dose Selection ◽

Phase 3 ◽

Infection Dose ◽

Exposure Response ◽

Chronic Hcv Infection ◽

Selection For ◽

Chronic Hcv

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1212 EXPOSURE-RESPONSE ANALYSES OF PEGYLATED INTERFERON LAMBDA (LAMBDA, BMS-914143) IN PATIENTS WITH CHRONIC HCV INFECTION: DOSE SELECTION FOR PHASE 3 CLINICAL TRIALS

Journal of Hepatology ◽

10.1016/s0168-8278(12)61224-0 ◽

2012 ◽

Vol 56 ◽

pp. S481

Author(s):

X. Wang ◽

P. Chan ◽

A. Ahmad ◽

J. Freeman ◽

A. Horga ◽

...

Keyword(s):

Clinical Trials ◽

Pegylated Interferon ◽

Hcv Infection ◽

Dose Selection ◽

Phase 3 ◽

Infection Dose ◽

Exposure Response ◽

Chronic Hcv Infection ◽

Selection For ◽

Chronic Hcv

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Exposure-response (E-R) analysis to facilitate phase III (P3) dose selection for ganitumab (GAN, AMG 479) in combination with gemcitabine (G) to treat metastatic pancreatic cancer (mPC).

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.4049 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. 4049-4049 ◽

Cited By ~ 1

Author(s):

J. Lu ◽

H. Deng ◽

R. Tang ◽

C. Hsu ◽

H. L. Kindler ◽

...

Keyword(s):

Pancreatic Cancer ◽

Phase Iii ◽

Metastatic Pancreatic Cancer ◽

Dose Selection ◽

Exposure Response ◽

Selection For

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286 EXPOSURE-RESPONSE RELATIONSHIP OF FILIBUVIR IN HCV INFECTED PATIENTS: APPLICATION TO DOSE SELECTION FOR COMBINATION THERAPY

Journal of Hepatology ◽

10.1016/s0168-8278(10)60288-7 ◽

2010 ◽

Vol 52 ◽

pp. S119-S120 ◽

Cited By ~ 1

Author(s):

S. Neelakantan ◽

V.S. Purohit ◽

M. O'Gorman ◽

J. Hammond ◽

T.G. Tensfeldt

Keyword(s):

Combination Therapy ◽

Response Relationship ◽

Dose Selection ◽

Exposure Response ◽

Selection For ◽

Relationship Of

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Recommendations for Dose Selection for Adolescent Patients in Relevant Adult Oncology Clinical Trials

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.2467 ◽

2021 ◽

Author(s):

Ruby Leong ◽

Qi Liu ◽

Lingjue Li ◽

Jiang Liu ◽

Yunzhao R. Ren ◽

...

Keyword(s):

Clinical Trials ◽

Dose Selection ◽

Adolescent Patients ◽

Oncology Clinical Trials ◽

Selection For

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Abstract CT196: Therapeutic dose selection for belantamab mafodotin, a BCMA-targeting agent, in patients with relapsed/refractory multiple myeloma (RRMM): Application of population pharmacokinetics (PopPK) and exposure-response (E-R) analyses

10.1158/1538-7445.am2020-ct196 ◽

2020 ◽

Author(s):

Geraldine Ferron-Brady ◽

Chetan Rathi ◽

Jon Collins ◽

Herbert Struemper ◽

Joanna Opalinska ◽

...

Keyword(s):

Multiple Myeloma ◽

Population Pharmacokinetics ◽

Therapeutic Dose ◽

Dose Selection ◽

Refractory Multiple Myeloma ◽

Exposure Response ◽

Selection For

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Population Pharmacokinetic and Exposure–Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease

Clinical Pharmacokinetics ◽

10.1007/s40262-019-00820-x ◽

2019 ◽

Vol 59 (3) ◽

pp. 359-370

Author(s):

Nelleke Snelder ◽

Roland Heinig ◽

Henk-Jan Drenth ◽

Amer Joseph ◽

Peter Kolkhof ◽

...

Keyword(s):

Type 2 Diabetes ◽

Chronic Kidney Disease ◽

Kidney Disease ◽

Response Analysis ◽

Population Pharmacokinetic ◽

Dose Selection ◽

Exposure Response ◽

Selection For

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Safety Assessment and Dose Selection for First-in-Human Clinical Trials With Immunomodulatory Monoclonal Antibodies

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2008.273 ◽

2009 ◽

Vol 85 (3) ◽

pp. 247-258 ◽

Cited By ~ 86

Author(s):

PY Muller ◽

FR Brennan

Keyword(s):

Clinical Trials ◽

Monoclonal Antibodies ◽

Safety Assessment ◽

Dose Selection ◽

Selection For

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Use of a Biomarker in Exposure-Response Analysis to Support Dose Selection for Fingolimod

CPT Pharmacometrics & Systems Pharmacology ◽

10.1038/psp.2013.44 ◽

2013 ◽

Vol 2 (8) ◽

pp. 67 ◽

Cited By ~ 7

Author(s):

J-Y Lee ◽

Y Wang

Keyword(s):

Response Analysis ◽

Dose Selection ◽

Exposure Response ◽

Selection For

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Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2010.06.007 ◽

2010 ◽

Vol 58 (2) ◽

pp. 243-251 ◽

Cited By ~ 27

Author(s):

Jay Tibbitts ◽

Joy A. Cavagnaro ◽

Christine A. Haller ◽

Ben Marafino ◽

Paul A. Andrews ◽

...

Keyword(s):

Clinical Trials ◽

Dose Selection ◽

Selection For

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