Single-Dose And Steady-State Pharmacokinetics Of Moxduo™, A Dual-Opioid Formulation Containing A Fixed Ratio Of Morphine And Oxycodone

Single-Dose And Steady-State Pharmacokinetics Of Moxduo™, A Dual-Opioid Formulation Containing A Fixed Ratio Of Morphine And Oxycodone

Authors: Webster L, Owen JS, Darling IM, Richards P, Kelen R, Stern W
Conference: American Pain Society (APS)
Keywords: accumulation index, central nervous, dose-normalized, female, general linear model, healthy, metabolites, neurology, noncompartmental, system agents, WinNonlin
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Q8003 (MoxDuo™) is the first dual-opioid combination product that has been evaluated in clinical trials. MoxDuo immediate-release capsules were developed for the management of acute moderate to severe…

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: Stone J, Jaworowicz DJ, Zajic S, Leung A, Duong LT, Passarell JA, Fiedler-Kelly J, Cohn D, Verbruggen N, Stoch A
Conference: International Symposium on Measurement and Kinetics of in vivo Drug Effects
Keywords: 1-compartment, biomarker, BSAP, dose-ranging, dose-response, exposure, geriatrics, Hill function, indirect response, Japanese, linear, LS-BMD, MK-0822, orthopedics, osteoclast, osteoporosis, resorption, saturable, turnover, uNTx, visual predictive check
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…

Prediction of Omeprazole’s Disposition and Drug-Drug Interactions Using A Physiologically-Based Pharmacokinetic Model

Prediction of Omeprazole’s Disposition and Drug-Drug Interactions Using A Physiologically-Based Pharmacokinetic Model

Authors: Lukacova V, Parrott N, Howard M, Woltosz WS, Bolger MB
Conference: ADMET Europe
Keywords: absorption, ACAT, advanced compartmental and transit (ACAT), DDIs, drug-drug interactions (DDIs), omeprazole, pharmacokinetics
Software: GastroPlus®
Division: PBPK

Download the poster presented at the ADMET Europe 2010 conference on the development of PBPK models and prediction of parent & metabolite DDIs with omeprazole.

Simulations of the Drug-Drug Interaction Between Atomoxetine and Quinidine in Poor and Extensive CYP2D6 Metabolizers

Simulations of the Drug-Drug Interaction Between Atomoxetine and Quinidine in Poor and Extensive CYP2D6 Metabolizers

Authors: Zhou H, Chung J, Lukacova V, Bolger MB, Woltosz WS
Conference: ISSX
Keywords: ADHD, atomoxetine, DDIs, drug-drug interactions (DDIs)
Software: GastroPlus®
Division: PBPK

Atomoxetine is indicated for attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. It is metabolized to 4- hydroxy-atomoxetine primarily by CYP2D6, which is known to have…

Population Pharmacokinetics of Dexmedetomidine (DEX) During Long-Term Continuous Infusion in Critically Ill Patients

Population Pharmacokinetics of Dexmedetomidine (DEX) During Long-Term Continuous Infusion in Critically Ill Patients

Authors: Fiedler-Kelly J, Ludwig E, Lu Q, Stalker D
Conference: ASCPT
Keywords: anesthesiology, Bayesian, central nervous system agents, ICU, intensive care, model validation, one compartment model, Phase 4, relative predictive performance, two-compartment model, ventilated, visual predictive check
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Dexmedetomidine (DEX), a selective alpha2-adrenoceptor agonist is approved for sedation. In this study, the population pharmacokinetics (PK) of DEX during long-term (> 24 hours) infusion was…

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...