Publication Archives

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…

CertaraFebruary 1, 2004

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…

CertaraNovember 1, 2003

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…

CertaraOctober 1, 2003

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…

CertaraJanuary 1, 2003

Publication

Combining Drug-disease and Economic Modeling to Inform Drug Development Decisions

Drug-disease models and clinical trial simulations are increasingly being used to support trial design and…

CertaraNovember 1, 2001

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…

CertaraDecember 1, 1999

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…

CertaraJune 1, 1999

Publication

The Determination of Drug Metabolizing Enzyme Activity In Vivo: Pharmacokinetics and Statistical Issues

Probe substrates for various isoforms of cytochrome P450 and other drug-metabolizing enzymes are now widely…

CertaraDecember 1, 1998

Publication

Caffeine Metabolic Ratios as Markers of Enzyme Activity: A Theoretical Assessment

At least six urinary metabolite ratios of caffeine have been proposed as probes for in…

CertaraApril 1, 1996

Publication

The future of Parkinson’s disease research: A new paradigm of human-specific investigation is necessary… and possible

Parkinson’s disease (PD) is a complex neurodegenerative condition with a multifactorial origin. To date, approaches…

CertaraApril 8, 0202

Publication

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

Combining Drug-disease and Economic Modeling to Inform Drug Development Decisions

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

The Determination of Drug Metabolizing Enzyme Activity In Vivo: Pharmacokinetics and Statistical Issues

Caffeine Metabolic Ratios as Markers of Enzyme Activity: A Theoretical Assessment

The future of Parkinson’s disease research: A new paradigm of human-specific investigation is necessary… and possible

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