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Incorporating Target Shedding into a Minimal PBPK-TMDD Model for Monoclonal Antibodies Blog Post

Shedding of a pharmacological target from cells, giving rise to a soluble target that can also bind therapeutic proteins, is a common phenomenon. In this study, a minimal physiologically based pharmacokinetic model was used to simulate the pharmacokinetics of…

Cassette Dosing: Advantages and Challenges Blog Post

Cassette dosing is a technique primarily used in drug discovery efforts in non-clinical studies to collect pharmacokinetic data from multiple drug candidates in a single experiment. A typical cassette dosing…

What is GLP (Good Laboratory Practice)? Blog Post

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits...

Bottom-up Modeling and Simulation of Tacrolimus Clearance: Prospective Investigation of Blood Cell Distribution, Sex and CYP3A5 Expression as Covariates and Assessment of Study Power Blog Post

The objectives were to investigate the ability of population-based in vitro-in vivo extrapolation (IVIVE) to reproduce the influence of haematocrit on the clearance of tacrolimus, observed previously, and to assess…

An Evaluation of the Pharmacokinetics of Treprostinil Diethanolamine in Subjects with Hepatic Impairment Blog Post

Treprostinil diolamine (oral treprostinil) is a prostacyclin analogue under evaluation for the treatment for pulmonary arterial hypertension (PAH). This study assessed the pharmacokinetics (PK) and safety of treprostinil following oral…

Differences in Cytochrome P450-mediated Pharmacokinetics Between Chinese and Caucasian Populations Predicted by Mechanistic Physiologically-based Pharmacokinetic Modeling Blog Post

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines emphasize the need for better understanding of the influence of ethnicity on drug response…

Understanding Steady State Pharmacokinetics Blog Post

Register for our July 10 webinar and discover fast, flexible, frictionless PK/PD workflows with Phoenix Cloud. “Steady state” is an important term in pharmacokinetics, but it can often seem a...

Absence of Pharmacokinetic Drug-drug Interaction of Pertuzumab with Trastuzumab and Docetaxel Blog Post

Pertuzumab is a novel antihuman epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody. Combined with trastuzumab plus docetaxel, pertuzumab improved progression-free and overall survival versus trastuzumab plus docetaxel in…

What is Identifiability? Blog Post

Developing models for pharmacokinetic or pharmacodynamic data requires creativity, patience, and hard work. Sometimes that creativity ends up violating mathematical principles which can lead to poorly fitting models and frustration…

Predicted Heart Rate Effect of Inhaled LABA PF-00610355 in Volunteers and COPD Patients Blog Post

The aim of this study was to assess the cardiovascular effects of a new inhaled long-acting β-adrenoceptor agonist PF-00610355 in COPD patients. Thirteen thousand and sixty-two heart rate measurements collected…