Model Informed Drug Development Archives

Publication

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355

PF-00610355 is an orally inhaled long-acting β2-adrenoreceptor agonist that is being developed for the once-daily…

CertaraJune 1, 2013

Publication

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences…

CertaraMay 13, 2013

Publication

Investigation of the Role of Fc-γ-R and FcRn in mAb Distribution to the Brain

To evaluate the role of Fc receptors (FcR) on IgG distribution to the brain, the disposition of 8C2, a murine…

CertaraMay 6, 2013

Publication

Synergistic Interactions between Sorafenib and Everolimus in Pancreatic Cancer Xenografts in Mice

Molecular targeting of cellular signaling pathways is a promising approach in cancer therapy, but often…

CertaraMay 1, 2013

Publication

A Physiologically-based Pharmacokinetic (PBPK) Approach to Evaluate Pharmacokinetics in Patients with Cancer

Potential differences in pharmacokinetics (PK) between healthy subjects and patients with cancer were investigated using…

CertaraApril 1, 2013

Publication

Effects of Monocarboxylate Transporter Inhibition on the Oral Toxicokinetics/Toxicodynamics of γ-hydroxybutyrate and γ-butyrolactone

Respiratory depression and death secondary to respiratory arrest have occurred after oral overdoses of γ-hydroxybutyrate…

CertaraApril 1, 2013

Publication

Model-based Drug Development in Oncology: What’s Next?

Model-based estimates of tumor growth inhibition (TGI) metrics have the potential to enhance learning in…

CertaraApril 1, 2013

Publication

Model-supported Development of CS-8635: A Fixed-dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide

CS-8635, a fixed-dose triple combination of olmesartan, amlodipine, and hydrochlorothiazide, was developed to address the…

CertaraApril 1, 2013

Publication

Axitinib in Metastatic Renal Cell Carcinoma: Results of a Pharmacokinetic and Pharmacodynamic Analysis

Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1, 2,…

CertaraMarch 28, 2013

Publication

A Poor Metabolizer of Both CYP2C19 and CYP2D6 Identified by Mechanistic Pharmacokinetic Simulation in a Fatal Drug Poisoning Case Involving Venlafaxine

We present a fatal drug poisoning case involving venlafaxine (VEN). The deceased took his medication…

CertaraMarch 10, 2013

Model Informed Drug Development

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

Investigation of the Role of Fc-γ-R and FcRn in mAb Distribution to the Brain

Synergistic Interactions between Sorafenib and Everolimus in Pancreatic Cancer Xenografts in Mice

A Physiologically-based Pharmacokinetic (PBPK) Approach to Evaluate Pharmacokinetics in Patients with Cancer

Effects of Monocarboxylate Transporter Inhibition on the Oral Toxicokinetics/Toxicodynamics of γ-hydroxybutyrate and γ-butyrolactone

Model-based Drug Development in Oncology: What’s Next?

Model-supported Development of CS-8635: A Fixed-dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide

Axitinib in Metastatic Renal Cell Carcinoma: Results of a Pharmacokinetic and Pharmacodynamic Analysis

A Poor Metabolizer of Both CYP2C19 and CYP2D6 Identified by Mechanistic Pharmacokinetic Simulation in a Fatal Drug Poisoning Case Involving Venlafaxine

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