A Systems Approach to Resource Allocation in an Integrated Research and Development Environment

A Systems Approach to Resource Allocation in an Integrated Research and Development Environment

Authors: Walawander CA, Grasela TH, Ruhland B, Vecchione P
Conference: Pharmaceutical Special Interest Group (PharmaSIG)
Keywords: drug development process, management, model based drug development, multidisciplinary, optimizing resources, project team, resource allocation model, successful organizations
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Typically, at the beginning of a project, the scope is defined along with the timelines and budget. As project team leaders negotiate with functional managers to recruit key team members, including…

Semi-mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women

Semi-mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women

Authors: Zajic S, Stone J, Jaworowicz DJ, Leung A, Duong LT, Passarell JA, Fiedler-Kelly J, Cohn D, Verbruggen N, Stoch A
Keywords: Odanacatib, PK/PD, PopPK, population pharmacokinetics
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Odanacatib (MK-0822), a potent, orally-active inhibitor of cathepsin K, is under clinical development for treatment of postmenopausal osteoporosis. This poster describes base model development of a...

Development of a Physiologically Based Pharmacokinetic (PBPK) Model for Predicting Deposition and Disposition follo · g Inhaled and Intranasal Administration

Development of a Physiologically Based Pharmacokinetic (PBPK) Model for Predicting Deposition and Disposition follo · g Inhaled and Intranasal Administration

Authors: Miller NA, Chaudhuri S, Lukacova V, Damian-Iordache V, Bayliss MK, Woltosz WS
Keywords: inhaled drug, intranasal drug, PBPK modeling, pharmacokinetic, plasma concentration, pulmonary, pulmonary playlist
Software: GastroPlus®
Division: PBPK

The selection of a biologically active molecule as a successful inhaled therapeutic agent depends on its pharmacokinetic and safety properties...

Modeling Drug Disposition of Timolol in Ocular Tissues of Rabbit following Topical Eye Drops

Modeling Drug Disposition of Timolol in Ocular Tissues of Rabbit following Topical Eye Drops

Authors: Chaudhuri S, Lukacova V, Woltosz WS
Conference: ISOPT
Keywords: clonidine, ocular, PBPK, rabbit, timolol
Software: GastroPlus®
Division: PBPK

Recently, we reported the successful application of a novel mathematical model describing drug disposition in eye compartments to simulate disposition of clonidine  after topical (eye drop) administration.

Prediction of pharmacokinetic profile of valsartan in human based on in vitro uptake transport data

Prediction of pharmacokinetic profile of valsartan in human based on in vitro uptake transport data

Authors: Poirier A, Cascais AC, Funk C, Lavé T
Publication: J Pharmacokinet Pharmacodyn
Keywords: administration and dosage, biological models, drug interaction, metabolism, oral administration, pharmacokinetics, rats
Software: GastroPlus®

The aim of this study was to evaluate a strategy based on a physiologically based pharmacokinetic (PBPK) model for the prediction of PK profiles in human using in vitro...

Optimizing the Performance of In Silico ADMET General Models According to Local Requirements: MARS Approach. Solubility Estimations As Case Study

Optimizing the Performance of In Silico ADMET General Models According to Local Requirements: MARS Approach. Solubility Estimations As Case Study

Authors: Oyarzabal J, Pastor J, Howe TJ
Publication: J Chem Inf Model
Keywords: ADME/Tox properties, in silico absorption, in vitro, predictive models
Software: ADMET Predictor®

The quality of in vitro data used to build in silico absorption, distribution, metabolism, and toxicity (ADMET) models is, in many cases, inconsistent.

Modeling Fluconazole – a Case with Concentration-Dependent Liver:Plasma Partition Coefficient

Modeling Fluconazole – a Case with Concentration-Dependent Liver:Plasma Partition Coefficient

Authors: Fraczkiewicz G, Parrott N, Lukacova V, Bolger MB, Crison JR, Woltosz WS, Lavé T
Conference: AAPS
Keywords: ADMET, antifungal, candidiasis, fluconazole, meningitis, PBPK
Software: ADMET Predictor®, GastroPlus®
Division: PBPK

Fluconazole is an antifungal agent widely used in the clinical setting   for the treatment of candidiasis and meningitis. It undergoes minimal metabolism and is excreted renally.