Therapeutic Specialties Archives

Publication

Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2

Transporter mRNA and protein expression data are used to extrapolate in vitro transporter kinetics to in…

CertaraApril 1, 2016

Publication

Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…

CertaraApril 1, 2016

Publication

Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma

The purpose of this study was to characterize the pharmacokinetics of oral trametinib, a first in…

CertaraApril 1, 2016

Publication

Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber)

To determine the pharmacokinetics of meloxicam in Caribbean flamingos ( Phoenicopterus ruber ruber), a pilot…

CertaraMarch 1, 2016

Publication

Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

CertaraMarch 1, 2016

Publication

Immune Cell-based Screening Assay for Response to Anticancer Agents: Applications in Pharmacogenomics

CertaraFebruary 26, 2016

Publication

Factors Influencing the Central Nervous System Distribution of a Novel Phosphoinositide 3-Kinase/Mammalian Target of Rapamycin Inhibitor GSK2126458: Implications for Overcoming Resistance with Combination Therapy for Melanoma Brain Metastases

CertaraFebruary 1, 2016

Publication

Population PK & Dosing Implications for Cobimetinib in Cancer Patients

A population pharmacokinetic model was developed for cobimetinib in cancer patients. Covariates had minimal impact…

CertaraNovember 1, 2015

Publication

Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects

Tramadol is frequently used in geriatric patients; however, pharmacokinetic (PK) publications on tramadol and O-desmethyltramadol…

CertaraOctober 27, 2015

Publication

Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients

The published OS model and resultant simulations can be leveraged to support Phase II design…

CertaraSeptember 1, 2015

Therapeutic Specialties

Breast Cancer Resistance Protein Abundance, but Not mRNA Expression, Correlates with Estron e-3-Sulfate Transport in Caco-2

Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

Population Pharmacokinetics and Exposure-response of Trametinib, a MEK Inhibitor, in Patients with BRAF V600 Mutation-positive Melanoma

Pharmacokinetics of a Single Dose of Oral and Subcutaneous Meloxicam in Caribbean Flamingos (Phoenicopterus ruber ruber)

Drug-drug Interactions and QT Prolongation as a Commonly Assessed Cardiac Effect—Comprehensive Overview of Clinical Trials

Immune Cell-based Screening Assay for Response to Anticancer Agents: Applications in Pharmacogenomics

Factors Influencing the Central Nervous System Distribution of a Novel Phosphoinositide 3-Kinase/Mammalian Target of Rapamycin Inhibitor GSK2126458: Implications for Overcoming Resistance with Combination Therapy for Melanoma Brain Metastases

Population PK & Dosing Implications for Cobimetinib in Cancer Patients

Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-release Tablets to Elderly and Young Subjects

Modeling & Simulation Relating Survival to Tumor Growth Inhibition in Patients

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