The use of in vitro data to predict the pharmacokinetics (PK) of drugs whose disposition is mediated by transporters is complicated due to unknown transporter expression levels in individual tissues both…
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation
Advances in predicting in vivo performance of drug products has the potential to change how drug products are developed and reviewed.
A sequence within the varicella-zoster virus (VZV) OriS is a negative regulator of DNA replication and is bound by a protein complex containing the VZV ORF29 protein
The architecture of the varicella-zoster virus (VZV) origin of DNA replication (OriS) differs significantly from that of the herpes simplex virus (HSV) DNA replication origin.
Simulations Plus Completes Molecule Design Phase, Issues RFQs for Molecule Synthesis
Company Uses Proprietary Software Tools to Design New Drug-like Molecules for Resistant Malaria Parasite
Pharmacokinetic (PK) And Pharmacodynamic (PD) Modeling Of Subcutaneous (Sc) Ly2189102, A Neutralizing IL-1 Beta Antibody, In Patients With Type 2 Diabetes Mellitus
LY2189102, a humanized neutralizing IL-1β antibody, was studied in type 2 diabetes mellitus (T2DM) patients with C-reactive protein (CRP) ≥ 2 mg/L, who received weekly subcutaneous doses of LY2189102…
Simulations Plus Reports Preliminary Revenues for Fourth Fiscal Quarter and FY2011
Pharmaceutical Software and Services Revenues Increase 6.9% for 4th Quarter, up 14.7% for the Fiscal Year
Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants
Physiologically based pharmacokinetic (PBPK) modelling can assist in the development of drug therapies and regimens suitable for challenging patient populations such as very young children.
In Vitro and In Silico Strategies to Identify OATP1B1 Inhibitors and Predict Clinical Drug–Drug Interactions
To establish in vitro and in silico models that predict clinical drug–drug interactions (DDIs) with the OATP1B1 (SLCO1B1) transporter.
Selection of oral bioavailability enhancing formulations during drug discovery
The objective of this paper was to identify oral bioavailability enhancing approaches for a poorly water-soluble research compound during drug discovery stages using minimal amounts of material.
SLP Subsidiary Words+ Launches EyePro GS™ System
In-house Design Widens Eye Gaze Offerings and Substantially Increases Margins
Pre-clinical and clinical pharmacokinetics of PF-02413873, a non-steroidal progesterone receptor antagonist
The recently discovered selective nonsteroidal progesterone receptor (PR) antagonist 4-[3-cyclopropyl-1-(methylsulfonylmethyl)-5-methyl-1H-pyrazol-4-yl]oxy-2,6-dimethylbenzonitrile (PF-02413873)...
Simulation of Tobramycin Pharmacokinetics After Topical Ophthalmic Administration
Tobramycin belongs to the class of aminoglycoside antibiotics. It does not bind to serum proteins [1], is eliminated mainly by renal secretion [2] and is poorly absorbed from the gastrointestinal tract [3].
Simulations Plus Reports Third Quarter FY2011 Financial Results and Announces Investor Conference Call
Record Quarterly Revenue of $3.44 Million; Consolidated Earnings Up 42% and EPS Up 49% from 3QFY10
The Application of Physiologically Based Pharmacokinetic Modelling to Understanding the Clinical Pharmacokinetics of UK-369,003
5-[2-Ethoxy-5-(4-ethyl-piperazine-1-sulfonyl)-pyridin-3-yl]-3-ethyl-2-(2-methoxy-ethyl)-2,6-dihydro-pyrazolo[4,3-d]pyrimidin-7-one (UK-369,003) is a phosphodiesterase-5...
Physiological modeling and assessments of regional drug bioavailability of danoprevir to determine whether a controlled release formulation is feasible
Danoprevir, a potent, selective inhibitor of HCV NS3/4A protease, has a short half-life in humans. Therefore, the feasibility of a controlled release (CR) formulation to allow less frequent dosing...
Optimism in a time of pessimism.
Back in 1974, Stewart Brand’s advice was to “stay hungry, stay foolish,” as a way of bringing a beginner’s mind to new challenges. He still follows that advice, and he now says, “The phrase allows you to open your mind and explore. It means putting aside the explanations provided by social constructs and ideologies.”
Semi-mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine and Distal Forearm Bone Mineral Density in a Phase IIb Study of Postmenopausal Women
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…
Simulations Plus Reports Preliminary Revenues for Third Fiscal Quarter of FY2011
Growth Trend Continues with Another Record Quarter