Development of generic formulations of ophthalmic corticosteroids and regulatory acceptance of bioequivalence can be facilitated by analysis of the mechanisms of ocular dissolution, absorption...
A Population-Based PK/PD Analysis Of Dasotraline Efficacy In The Treatment Of ADHD In Adults
Dasotraline (SEP-225289) is a new chemical entity with a slow elimination half-life demonstrating dopamine (DAT) and norepinephrine (NET) transporter inhibition in clinical studies. Here we hypothesized…
Eslicarbazepine Acetate Drug–Drug Interactions: Characterization Through a Model-Based Population Approach
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved by the US Food and Drug Administration for the treatment of partial-onset seizures (POS) as monotherapy or...
Eslicarbazepine Acetate Monotherapy: A Population Ppharmacokinetic Analysis
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved by the US Food and Drug Administration for the treatment of partial-onset seizures (POS) as monotherapy or…
Relationship between exposure and efficacy of eslicarbazepine acetate monotherapy
Eslicarbazepine acetate (ESL) is a once-daily, oral antiepileptic drug (AED), approved by the US Food and Drug Administration for the treatment of partialonset seizures (POS) as monotherapy or adjunctive...
Relationship Between Eslicarbazepine Exposure and Efficacy of Eslicarbazepine Acetate Adjunctive Therapy
Eslicarbazepine acetate (ESL; Aptiom®) is a novel once-daily (QD) oral antiepileptic drug, approved in then US, Canada and the EU as adjunctive treatment of partial-onset seizures (POS). ESL is extensively...
Relationship Between Eslicarbazepine Exposure and Safety Endpoints for Eslicarbazepine Acetate Adjunctive Therapy
Eslicarbazepine acetate (ESL) is a once-daily (QD) oral antiepileptic drug (AED), approved in the US, Canada and the EU as adjunctive treatment of partial-onset seizures (POS). After oral administration, ESL...
Relationship Between Eslicarbazepine Exposure and Safety Endpoints for Eslicarbazepine Acetate Monotherapy
In two Phase III trials (093-045 and -046) of eslicarbazepine acetate (ESL) monotherapy in patients with partial-onset seizures (POS) uncontrolled by 1−2 antiepileptic drugs (AEDs), the incidence of...
Novel Physiologically-Based Oral Cavity Model and Its Application for Projection of Clinical Pharmacokinetics of Intermezzo® Sublingual Tablets
Intraoral (IO) delivery refers to an alternative administration route that intends to deliver the drug substance through oral mucosa. The intraoral route provides several advantages over conventional...
Prediction of Acyclovir Pharmacokinetics in Pediatric Populations using a Physiologically Based Pharmacokinetic (PBPK) Model
To develop a PBPK model for acyclovir incorporating processes affecting the drug's absorption and distribution after i.v. administration of acyclovir (ACV) as well as its in vivo formation after p.o. admin…
Mechanistic Nucleation and Growth Can Predict Nonlinear Dose-Dependent Precipitation of Enabled Fomulations of Nimodipine in GastroPlus™
Simulation of precipitation can be important for accurate prediction of the absorption of many oral formulations. Amorphous solid dispersions, salt forms, cocrystals, solutions, and nanoparticles all can…
Physiologically Based Pharmacokinetic Modeling of Buspirone and the Effect of Liver Cirrhosis on Its Deposition
The aim of this work was to develop a physiologically based pharmacokinetic (PBPK) model of buspirone following oral administrations in healthy volunteers, and to extend this model to predict the…
Novel Skin PBPK model in Action: Clindamycin and Tazarotene Modeling
Skin is the major organ in the human body with a complex barrier that serves as protection from the external environment. Predicting dermal and systemic exposures of drug following topical application...
Population Modeling Is a Critical Element of Bridging Pharmacokinetic Data From Dried Blood Spot and Plasma Across Clinical Programs
To demonstrate through two case studies how population pharmacokinetic (PK) modeling should be leveraged for bridging plasma and dried blood spot (DBS) PK data across clinical development programs.
Systems Pharmacology Modeling Predicts Hepatotoxic Potential Of Troglitazone And Pioglitazone
Troglitazone (TGZ) caused life-threatening drug-induced liver injury (DILI) in diabetic patients, whereas the next in class, pioglitazone (PGZ), has rarely been associated with DILI. Inhibition of bile acid...
Computational models for improved estimation of highly plasma-protein-bound compounds
Plasma protein binding is an important parameter for characterizing the pharmacokinetics of drug candidates.
KIWI: A Collaborative Platform for Modeling and Simulation
Drug development programs rely increasingly on pharmacometric analysis to support decision-making and submissions to regulatory agencies.1,2 To ensure high quality analysis, organizations must apply…
Tedizolid Plasma Pharmacokinetics Are Comparable in Obese and Nonobese Patients and Healthy Subjects
Tedizolid phosphate is a novel oxazolidinone prodrug antibacterial being investigated for the treatment of Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus.
Impact of Delayed-Dose Administration of USL255, Qudexy™ XR (Topiramate) Extended-Release Capsules
Despite the importance of medication adherence for successful management of seizure disorders, nonadherence continues to be a significant problem in patients with epilepsy.
Computational Modeling of OATP1B1 Inhibitors
This poster was presented at the 2014 SOT meeting. It describes where the OATP1b1 data originated and the cutoff value. The model, including descriptors, is discussed.