Model Informed Drug Development Archives

Publication

Dose Correction for the Michaelis-Menten Approximation of the Target—Mediated Drug Disposition Model

The Michaelis-Menten (M-M) approximation of the target-mediated drug disposition (TMDD) pharmacokinetic (PK) model was derived…

CertaraAugust 23, 2012

Publication

The Right Compound in the Right Assay at the Right Time: An Integrated Discovery DMPK Strategy

The high rate of attrition during drug development and its associated high research and development…

CertaraAugust 1, 2012

Publication

Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone Effects on iNOS mRNA Expression and Nitric Oxide During LPS-induced Inflammation in Rats

Increased expression of inducible nitric oxide synthase (iNOS) resulting in nitric oxide elevation represents an…

CertaraAugust 1, 2012

Publication

γ-hydroxybutyrate (GHB)-induced Respiratory Depression: Combined Receptor-transporter Inhibition Therapy for Treatment in GHB Overdose

Overdose of & γ;-hydroxybutyrate (GHB) frequently causes respiratory depression, occasionally resulting in death; however, little…

CertaraAugust 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

Publication

Sex Differences in the Clearance of CYP3A4 Substrates: Exploring Possible Reasons for the Substrate Dependency and Lack of Consensus

Sex differences in the clearance of substrates of Cytochrome P4503A (CYP3A4) have been reported frequently…

CertaraJuly 1, 2012

Publication

Prediction of Concentration-time Profile and Its Inter-individual Variability Following the Dermal Drug Absorption

Estimation of systemic exposure after absorption of any xenobiotic from the skin is very important…

CertaraJuly 1, 2012

Publication

Physiologically-based Pharmacokinetics Joined with In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

Classic pharmacokinetics (PK) rarely takes into account the full knowledge of physiology and biology of…

CertaraJuly 1, 2012

Publication

A Mechanistic Pharmacokinetic Model to Assess Modified Oral Drug Bioavailability Post Bariatric Surgery in Morbidly Obese Patients: Interplay Between CYP3A Gut Wall Metabolism, Permeability, and Dissolution

Due to the multi-factorial physiological implications of surgery, attempts to explain trends in oral bioavailability following bariatric…

CertaraJune 11, 2012

Publication

Prediction of Drug Clearance in a Smoking Population: Modeling the Impact of Variable Cigarette Consumption on the Induction of CYP1A2

The objective of this study was to derive estimates of CYP1A2 abundance as a function…

CertaraJune 1, 2012

Model Informed Drug Development

Dose Correction for the Michaelis-Menten Approximation of the Target—Mediated Drug Disposition Model

The Right Compound in the Right Assay at the Right Time: An Integrated Discovery DMPK Strategy

Pharmacokinetic/Pharmacodynamic Modeling of Methylprednisolone Effects on iNOS mRNA Expression and Nitric Oxide During LPS-induced Inflammation in Rats

γ-hydroxybutyrate (GHB)-induced Respiratory Depression: Combined Receptor-transporter Inhibition Therapy for Treatment in GHB Overdose

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

Sex Differences in the Clearance of CYP3A4 Substrates: Exploring Possible Reasons for the Substrate Dependency and Lack of Consensus

Prediction of Concentration-time Profile and Its Inter-individual Variability Following the Dermal Drug Absorption

Physiologically-based Pharmacokinetics Joined with In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology

A Mechanistic Pharmacokinetic Model to Assess Modified Oral Drug Bioavailability Post Bariatric Surgery in Morbidly Obese Patients: Interplay Between CYP3A Gut Wall Metabolism, Permeability, and Dissolution

Prediction of Drug Clearance in a Smoking Population: Modeling the Impact of Variable Cigarette Consumption on the Induction of CYP1A2

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