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A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine Blog Post

The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion as well as drug attributes including protein and lipid binding, ionization, relative magnitude of passive and active…

A Randomised Study of the Effect of Danoprevir/Ritonavir or Ritonavir on Substrates of Cytochrome P450 (CYP) 3A and 2C9 in Chronic Hepatitis C Patients Using a Drug Cocktail Blog Post

The Simcyp Population-based Simulator: Architecture, Implementation, and Quality Assurance Blog Post

Developing a user-friendly platform that can handle a vast number of complex physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) models both for conventional small molecules and larger biologic drugs is a…

Intravenous Topiramate: Safety and Pharmacokinetics Following a Single Dose in Patients with Epilepsy or Migraines Taking Oral Topiramate Blog Post

Although topiramate is widely prescribed for epilepsy and migraine, there is no intravenous product. We have developed an injectable topiramate formulation in which the drug is solubilized in a cyclodextrin…

Intravenous Topiramate: Comparison of Pharmacokinetics and Safety with the Oral Formulation in Healthy Volunteers Blog Post

Although oral topiramate (TPM) products are widely prescribed for migraines and epilepsy, injectable TPM is not available for human use. We have developed a solubilized TPM formulation using a cyclodextrin matrix, captisol…

Application of In Vitro-In Vivo Extrapolation (IVIVE) and Physiologically-based Pharmacokinetic Modeling to Investigate the Impact of the CYP2C8 Polymorphism on Rosiglitazone Exposure Blog Post

The purpose of this study was to predict the impact of the CYP2C8*3 genotype on rosiglitazone exposure in the absence and presence of trimethoprim. Prior in vitro and in vivo…

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355 Blog Post

PF-00610355 is an orally inhaled long-acting β2-adrenoreceptor agonist that is being developed for the once-daily treatment of chronic obstructive pulmonary disease (COPD). The pharmacological effect is exerted in the lungs….

Age Related Changes in Fractional Elimination Pathways for Drugs: Assessing the Impact of Variable Ontogeny on Metabolic Drug-drug Interactions Blog Post

The magnitude of any metabolic drug-drug interactions (DDIs) depends on fractional importance of inhibited pathway which may not necessarily be the same in young children when compared to adults. The…

Investigation of the Role of Fc-γ-R and FcRn in mAb Distribution to the Brain Blog Post

To evaluate the role of Fc receptors (FcR) on IgG distribution to the brain, the disposition of 8C2, a murine monoclonal IgG1 antibody, was investigated after intravenous administration in FcRn α-chain knockout mice, FcγRIIb knockout mice, FcγRI/RIII…

Biodistribution and Pharmacokinetics of EGFR-targeted Thiolated Gelatin Nanoparticles Following Systemic Administration in Pancreatic Tumor-bearing Mice Blog Post

The objective of this study was to evaluate qualitative and quantitative biodistribution of epidermal growth factor receptor (EGFR)-targeted thiolated type B gelatin nanoparticles in vivo in subcutaneous human pancreatic adenocarcinoma…

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