Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis

Dealing with the complex drug-drug interactions: Towards mechanistic models

(2015) Manthena V. Varma et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective

(2015) HM Jones et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Phase 1/2 study of orteronel (TAK-700), an investigational 17,20-lyase inhibitor, with docetaxel–prednisone in metastatic castration-resistant prostate cancer

(2015) Daniel P. Petrylak et al.   INVESTIGATIONAL NEW DRUGS

Phase III, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or After Docetaxel-Based Therapy: ELM-PC 5

(2015) Karim Fizazi et al.   JOURNAL OF CLINICAL ONCOLOGY

Emerging areas of research in the assessment of pharmacokinetics in patients with chronic kidney disease

(2015) Michael A. Tortorici et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial

(2015) Fred Saad et al.   LANCET ONCOLOGY

Assessment of cytochrome P450-mediated drug-drug interaction potential of orteronel and exposure changes in patients with renal impairment using physiologically based pharmacokinetic modeling and simulation

(2014) Chuang Lu et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Complex Disease-, Gene-, and Drug-Drug Interactions: Impacts of Renal Function, CYP2D6 Phenotype, and OCT2 Activity on Veliparib Pharmacokinetics

(2014) J. Li et al.   CLINICAL CANCER RESEARCH

Phase I/II Trial of Orteronel (TAK-700)—an Investigational 17,20-Lyase Inhibitor—in Patients with Metastatic Castration-Resistant Prostate Cancer

(2014) Robert Dreicer et al.   CLINICAL CANCER RESEARCH

Towards Quantitation of the Effects of Renal Impairment and Probenecid Inhibition on Kidney Uptake and Efflux Transporters, Using Physiologically Based Pharmacokinetic Modelling and Simulations

(2013) Vicky Hsu et al.   CLINICAL PHARMACOKINETICS

Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

(2012) Joseph A. Grillo et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Effect of a novel 17,20-lyase inhibitor, orteronel (TAK-700), on androgen synthesis in male rats

(2012) Takahito Hara et al.   JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Physiologically-Based Pharmacokinetics in Drug Development and Regulatory Science

(2011) Malcolm Rowland et al.   Annual Review of Pharmacology and Toxicology

Discovery of orteronel (TAK-700), a naphthylmethylimidazole derivative, as a highly selective 17,20-lyase inhibitor with potential utility in the treatment of prostate cancer

(2011) Tomohiro Kaku et al.   BIOORGANIC & MEDICINAL CHEMISTRY

Modeling and predicting drug pharmacokinetics in patients with renal impairment

(2011) Karen Rowland Yeo et al.   Expert Review of Clinical Pharmacology

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS