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 ◽

Author(s):

Jay Tibbitts ◽

Joy A. Cavagnaro ◽

Christine A. Haller ◽

Ben Marafino ◽

Paul A. Andrews ◽

...

Keyword(s):

Clinical Trials ◽

Dose Selection ◽

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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 ◽

Author(s):

Chuanpu Hu ◽

Zhenling Yao ◽

Yang Chen ◽

Bruce Randazzo ◽

Liping Zhang ◽

...

Keyword(s):

Clinical Trials ◽

Comprehensive Evaluation ◽

Dose Selection ◽

Exposure Response ◽

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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 ◽

Author(s):

P. Chan ◽

E. Tafoya ◽

T. Eley ◽

B. He ◽

P. Mendez ◽

...

Keyword(s):

Clinical Trials ◽

Hcv Infection ◽

Dose Selection ◽

Phase 3 ◽

Infection Dose ◽

Exposure Response ◽

Chronic Hcv Infection ◽

Selection For ◽

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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 ◽

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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 ◽

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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 ◽

Author(s):

PY Muller ◽

FR Brennan

Keyword(s):

Clinical Trials ◽

Monoclonal Antibodies ◽

Safety Assessment ◽

Dose Selection ◽

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A Call for Objective Dose Selection to Increase Success in Pediatric Clinical Trials: A Perspective From NICHD and NIMH Program Staff

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1849 ◽

2021 ◽

Vol 61 (S1) ◽

Author(s):

George Giacoia ◽

Margaret C. Grabb ◽

Aaron C. Pawlyk ◽

Zhaoxia Ren ◽

Lesly Samedy‐Bates ◽

...

Keyword(s):

Clinical Trials ◽

Dose Selection ◽

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Principles Underlying Dose Selection for, and Extrapolation from, the Carcinogen Bioassay: Dose Influences Mechanism

Regulatory Toxicology and Pharmacology ◽

10.1006/rtph.1995.1056 ◽

1995 ◽

Vol 21 (3) ◽

pp. 418-421 ◽

Author(s):

J.L. Counts ◽

J.I. Goodman

Keyword(s):

Dose Selection ◽

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Radiosurgical Dose Selection for Secreting Pituitary Adenomas

World Neurosurgery ◽

10.1016/j.wneu.2013.02.079 ◽

2014 ◽

Vol 82 (1-2) ◽

pp. e71-e73

Author(s):

Bruce E. Pollock

Keyword(s):

Pituitary Adenomas ◽

Dose Selection ◽

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Approaches for Optimal Dose Selection for Adaptive Design Trials

Practical Considerations for Adaptive Trial Design and Implementation - Statistics for Biology and Health ◽

10.1007/978-1-4939-1100-4_7 ◽

2014 ◽

pp. 125-137 ◽

Author(s):

David Lawrence ◽

Frank Bretz

Keyword(s):

Adaptive Design ◽

Optimal Dose ◽

Dose Selection ◽

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Variation in Severity Assessment and Initial Mesalamine Dose Selection for Ulcerative Colitis in Community Practice

Journal of Clinical Gastroenterology ◽

10.1097/00004836-200608000-00005 ◽

2006 ◽

Vol 40 (7) ◽

pp. 587-591 ◽

Author(s):

Bruce E. Sands ◽

Karl M. Kilgore ◽

Richard S. Bloomfeld ◽

William J. Sandborn

Keyword(s):

Ulcerative Colitis ◽

Severity Assessment ◽

Community Practice ◽

Dose Selection ◽

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