Model Informed Drug Development Archives

Publication

Assessment of In Vivo CYP2D6 Activity: Differential Sensitivity of Commonly Used Probes to Urine pH

Drug/metabolite ratios (MRs) are used as in vivo markers of enzyme activity. The ratios are…

Certara2004 年 12 月 1 日

Publication

Predicting the Clearance of CYP2C9 Substrates

Recently, Andersson et al. (2004) reported that quantitative predictions of hepatic clearance from in vitro…

Certara2004 年 12 月 1 日

Publication

Cytochrome P450 3A Expression and Activity in the Human Small Intestine

Recently, von Richter et al measured the content of cytochrome P450 (CYP) 3A in paired…

Certara2004 年 10 月 1 日

Publication

Pharmacogenetics—Expectations and Reality

Thirty years have passed since Mike Rawlins, the current chairman of the National Institute for…

Certara2004 年 7 月 1 日

Publication

Prediction of Clearance from Recombinantly Expressed CYPs: Intersystem Extrapolation Factor (ISEF)

Recombinantly expressed human cytochromes P450 (rhCYPs) have been underused for the prediction of human drug…

Certara2004 年 2 月 1 日

Publication

The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain

Pregabalin is being evaluated for the treatment of neuropathic pain. Two phase 2 studies were…

Certara2003 年 11 月 1 日

Publication

The Effects of Dose Staggering on Metabolic Drug-drug Interactions

The purpose of this study was to investigate the effect of dose staggering on metabolic…

Certara2003 年 10 月 1 日

Publication

Pharmacokinetics of Melagatran and the Effect on Ex Vivo Coagulation Time in Orthopedic Surgery Patients Receiving Subcutaneous Melagatran and Oral Ximelagatran: A Population Model Analysis

Ximelagatran, an oral direct thrombin inhibitor, is rapidly bioconverted to melagatran, its active form. The…

Certara2003 年 1 月 1 日

Publication

A Population Pharmacokinetic/Pharmacodynamic Analysis of Repeated Measures Time-to-event Pharmacodynamic Responses: The Antiemetic Effect of Ondansetron

This paper presents and illustrates methodology for specifying, estimating, and evaluating a predictive model for…

Certara1999 年 12 月 1 日

Publication

In Vivo Indices of Enzyme Activity—The Effect of Renal Impairment on the Assessment of CYP2D6 Activity

Urinary drug metabolite ratios and urinary recoveries of metabolites, have been used to assess specific…

Certara1999 年 6 月 1 日

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Assessment of In Vivo CYP2D6 Activity: Differential Sensitivity of Commonly Used Probes to Urine pH

Predicting the Clearance of CYP2C9 Substrates

Cytochrome P450 3A Expression and Activity in the Human Small Intestine

Pharmacogenetics—Expectations and Reality

Prediction of Clearance from Recombinantly Expressed CYPs: Intersystem Extrapolation Factor (ISEF)

The Use of Clinical Trial Simulation to Support Dose Selection: Application to Development of a New Treatment for Chronic Neuropathic Pain

The Effects of Dose Staggering on Metabolic Drug-drug Interactions

Pharmacokinetics of Melagatran and the Effect on Ex Vivo Coagulation Time in Orthopedic Surgery Patients Receiving Subcutaneous Melagatran and Oral Ximelagatran: A Population Model Analysis

A Population Pharmacokinetic/Pharmacodynamic Analysis of Repeated Measures Time-to-event Pharmacodynamic Responses: The Antiemetic Effect of Ondansetron

In Vivo Indices of Enzyme Activity—The Effect of Renal Impairment on the Assessment of CYP2D6 Activity

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