Výsledky vyhledávání

Model-Based Meta-Analysis Use in the Development of Therapeutic Proteins

Autor: Timothy J. Taylor, Angela D. Taylor, Bill Frame

Publikováno v: Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases ISBN: 9781119289234
Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::adbe784958235f8c26c44a206b544b17
https://doi.org/10.1002/9781119289234.ch5

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Exposure-response modeling of average daily pain score, and dizziness and somnolence, for mirogabalin (DS-5565) in patients with diabetic peripheral neuropathic pain

Autor: Domenico Merante, Bill Frame, Raymond Miller, Matthew M. Hutmacher, Kenneth E. Truitt

Publikováno v: The Journal of Clinical Pharmacology. 56:67-77

Mirogabalin (DS-5565) is an α2δ-1 ligand being developed for pain associated with diabetic peripheral neuropathy, fibromyalgia, and postherpetic neuralgia. Nonlinear mixed-effects analyses were performed on average daily pain and on the incidence o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5b21bc155e9fc0dafe150d8e807259f3
https://doi.org/10.1002/jcph.567

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Population Pharmacokinetic-Pharmacodynamic Modeling of Biological Agents: When Modeling Meets Reality

Autor: Diane R. Mould, Bill Frame

Publikováno v: The Journal of Clinical Pharmacology. 50:91S-100S

The pharmacokinetics (PK) and pharmacodynamics (PD) of many biological agents (biologics) have inherent complexities requiring specialized approaches to develop reliable, unbiased models. Three cases are covered: preponderance of zero values, nonresp

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e8b64c0a82e05af3932119f9ddc3b5c5
https://doi.org/10.1177/0091270010376965

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Hepatic absorbed radiation dosimetry during I-131 Metaiodobenzylguanadine (MIBG) therapy for refractory neuroblastoma

Autor: Bill Frame, Denise Regan, Katherine K. Matthay, Kenneth F. Koral, Daniel P. Normolle, Gregory A. Yanik, John M. Maris, John P. Huberty

Publikováno v: European Journal of Nuclear Medicine and Molecular Imaging. 35:2105-2112

To compare the prediction of therapeutic hepatic radiation-absorbed dose rates from tracer imaging plus a linearity assumption to estimation based on intra-therapy imaging in (131)I metaiodobenzylguanidine (MIBG) therapy of refractory neuroblastoma.C

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c1d492cf19e362698f4ffc19e19f0606
https://doi.org/10.1007/s00259-008-0873-3

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Exposure-response modeling of average daily pain score, and dizziness and somnolence, for mirogabalin (DS-5565) in patients with diabetic peripheral neuropathic pain

Autor: Matthew M, Hutmacher, Bill, Frame, Raymond, Miller, Kenneth, Truitt, Domenico, Merante

Publikováno v: Journal of clinical pharmacology. 56(1)

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::9c6f9a1fda5414c89a95e73dda68a5a0
https://pubmed.ncbi.nlm.nih.gov/26073181

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A Two-Part Mixture Model for Longitudinal Adverse Event Severity Data

Autor: Kenneth G. Kowalski, Bill Frame, Matthew M. Hutmacher, Raymond Miller, Lynn McFadyen

Publikováno v: Journal of Pharmacokinetics and Pharmacodynamics. 30:315-336

We fit a mixed effects logistic regression model to longitudinal adverse event (AE) severity data (four-point ordered categorical response) to describe the dose-AE severity response for an investigational drug. The distribution of the predicted inter

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d7ce89617e0a6f65e984d9d3219cfde2
https://doi.org/10.1023/b:jopa.0000008157.26321.3c

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Evaluation of Mixture Modeling with Count Data Using NONMEM

Autor: Raymond Miller, Richard L. Lalonde, Bill Frame

Publikováno v: Journal of Pharmacokinetics and Pharmacodynamics. 30:167-183

Mixture modeling within the context of pharmacokinetic (PK)/pharmacodynamic (PD) mixed effects modeling is a useful tool to explore a population for the presence of two or more subpopulations, not explained by evaluated covariates. At present, statis

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0664ec2d097df664fa75ab4a784ac439
https://doi.org/10.1023/a:1025564409649

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Population Pharmacokinetics of Clinafloxacin in Healthy Volunteers and Patients with Infections

Autor: Jeffrey R. Koup, Richard L. Lalonde, Bill Frame, Raymond Miller

Publikováno v: Clinical Pharmacokinetics. 40:307-315

Objective: Clinafloxacin is a new fluoroquinolone antibacterial with inhibitory activity against aerobic, anaerobic and atypical bacterial pathogens. The objectives of this study are to evaluate the pharmacokinetics of clinafloxacin in healthy volunt

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::216b6639188aea41805853827dc0a139
https://doi.org/10.2165/00003088-200140040-00006

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Population Pharmacokinetics of Continuous Infusion Ceftazidime

Autor: Steve N. Triesenberg, David P. Nicolau, Bill Frame, Bryan F. Facca

Publikováno v: Clinical Pharmacokinetics. 37:343-350

The purpose of this study was to develop and validate a model that predicts clearance and steady-state ceftazidime concentrations during continuous infusion.This was a prospective clinical observational trial. Two models describing drug clearance dur

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c14ba90b775389ed1680391c89d70207
https://doi.org/10.2165/00003088-199937040-00005

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Joint modeling of dizziness, drowsiness, and dropout associated with pregabalin and placebo treatment of generalized anxiety disorder

Autor: Matthew M. Hutmacher, Raymond Miller, Bill Frame

Publikováno v: Journal of pharmacokinetics and pharmacodynamics. 36(6)

Dizziness and drowsiness are cited as being predictors of dropout from clinical trials for the medicine pregabalin. These adverse events are typically recorded daily on a four point ordinal scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), with m

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::64855c532453850cbb06166479f2c9e0
https://pubmed.ncbi.nlm.nih.gov/19904583

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