Therapeutic Specialties Archives

Publication

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus

The G-protein-coupled receptor 40 agonist (GPR40) TAK-875 is being developed as an adjunct to diet…

CertaraJanuary 9, 2013

Publication

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response

Recent data suggest that the role of CYP3A4 in imatinib metabolism is smaller than presumed.…

CertaraJanuary 1, 2013

Publication

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

A phase II trial in metastatic breast cancer (MBC) (NO16853) failed to show noninferiority (progression-free…

CertaraDecember 26, 2012

Publication

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

Simulations were performed for carboplatin/paclitaxel (C/P) plus motesanib or bevacizumab vs. C/P as first-line treatment…

CertaraNovember 1, 2012

Publication

Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery

Edoxaban is an oral direct factor Xa inhibitor approved for the prevention of venous thromboembolism…

CertaraNovember 1, 2012

Publication

Microdialysis Evaluation of Clozapine and N-desmethylclozapine Pharmacokinetics in Rat Brain

A significant barrier to realization of the full potential of clozapine as a therapeutic agent…

CertaraOctober 1, 2012

Publication

Relationship Between Prenatal Exposure to Polychlorinated Biphenyls and Birth Weight: A Systematic Analysis of Published Epidemiological Studies Through a Standardization of Biomonitoring Data

Impact of prenatal PCB exposure on birth weight was investigated in various children cohorts and…

CertaraOctober 1, 2012

Publication

Armodafinil and Modafinil in Patients with Excessive Sleepiness Associated with Shift Work Disorder: A Pharmacokinetic and Pharmacodynamic Model for Predicting and Comparing Their Concentration-effect Relationships

Armodafinil, the longer lasting R-isomer of racemic modafinil, improves wakefulness in patients with excessive sleepiness…

CertaraSeptember 1, 2012

Publication

Dealing with Excess of Zeros in the Statistical Analysis of Magnetic Resonance Imaging Lesion Count in Multiple Sclerosis

Lesion count observed on brain magnetic resonance imaging scan is a common end point in…

CertaraSeptember 1, 2012

Publication

Population Pharmacokinetics of Vernakalant Hydrochloride Injection (RSD1235) in Patients with Atrial Fibrillation or Atrial Flutter

Vernakalant hydrochloride is a novel, predominantly atrial-selective antiarrhythmic drug that effectively and rapidly terminates atrial…

CertaraJuly 1, 2012

Therapeutic Specialties

Pharmacometric Approaches to Guide Dose Selection of the Novel GPR40 Agonist TAK-875 in Subjects with Type 2 Diabetes Mellitus

Autoinhibition of CYP3A4 Leads to Important Role of CYP2C8 in Imatinib Metabolism: Variability in CYP2C8 Activity May Alter Plasma Concentrations and Response

Simulations to Assess Phase 2 Non-inferiority Trials of Different Doses of Capecitabine in Combination with Docetaxel for Metastatic Breast Cancer

Simulations Using a Drug-disease Modeling Framework and Phase 2 Data Predict Phase 3 Survival Outcome in First-line Non-small Cell Lung Cancer

Characterization of Exposure Versus Response of Edoxaban in Patients Undergoing Total Hip Replacement Surgery

Microdialysis Evaluation of Clozapine and N-desmethylclozapine Pharmacokinetics in Rat Brain

Relationship Between Prenatal Exposure to Polychlorinated Biphenyls and Birth Weight: A Systematic Analysis of Published Epidemiological Studies Through a Standardization of Biomonitoring Data

Armodafinil and Modafinil in Patients with Excessive Sleepiness Associated with Shift Work Disorder: A Pharmacokinetic and Pharmacodynamic Model for Predicting and Comparing Their Concentration-effect Relationships

Dealing with Excess of Zeros in the Statistical Analysis of Magnetic Resonance Imaging Lesion Count in Multiple Sclerosis

Population Pharmacokinetics of Vernakalant Hydrochloride Injection (RSD1235) in Patients with Atrial Fibrillation or Atrial Flutter

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