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Cognigen Launches KIWI Version 4.0
Exciting New Features to its Pharmacometric Communication and Collaboration Platform
“Development of Fixed Dose Combination Products” Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy
The gastrointestinal (GI) tract is one of the most popular and used routes of drug product administration due to the convenience for better patient compliance and reduced costs to the patient compared to other routes.
Metabolites of Vinca Alkaloid Vinblastine: Tubulin Binding and Activation of Nausea-Associated Receptors
Vinblastine (VLB) is an antimitotic drug that binds to the vinca site of tubulin.
Investigation of potent inhibitors of cholinesterase based on thiourea and pyrazoline derivatives: Synthesis, inhibition assay and molecular modeling studies
Owing to the desperate need of new drugs development to treat Alzheimer's ailment the synthesis of 1-aroyl-3-(5-(4-chlorophenyl)-1,2,4-triazole-3-thioneaminylthioureas (2–6)...
Ceftolozane/tazobactam population pharmacokinetics and dose selection for further clinical evaluation in pediatric patients with complicated urinary tract or complicated intraabdominal infections
Ceftolozane-tazobactam, a combination of the novel antipseudomonal cephalosporin ceftolozane and the...
In Silico Design of Dapsone Analogues Effective Towards Enoyl Acyl Carrier Protein Reductase Enzyme of Mycrobacterium Leprae
A series of new antileprotic drugs targeting enoyl acyl carrier protein reductase (ENR) enzyme of Mycobacterium lepraewere designed by in silico techniques.
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ADMET Predictor 9.5 Installation
This video shows how to install ADMET Predictor® 9.5
Insights into DPI sensitivity to humidity: An integrated in-vitro-in-silico risk-assessment
Dry powder inhalers (DPIs) are known to be sensitive to humidity. Erroneous storage of these products by patients in high humidity environments, could present a potential risk.
Toward the establishment of a standardized pre-clinical porcine model to predict food effects – Case studies on fenofibrate and paracetamol
A preclinical porcine model that reliably predicts human food effect of fenofibrate was developed. Fenofibrate was administered to pigs as model compound with a positive food effect.
Exposure-response (E-R) analysis of efficacy of pegvorhyaluronidase alfa (PEGPH20) in combination with nab-paclitaxel + gemcitabine (AG) in patients (Pts) with metastatic pancreatic ductal adenocarcinoma
PEGPH20 depolymerizes extracellular matrix hyaluronan (HA) and is an investigational agent for the treatment of pts with HA-accumulating tumors
Solidified SNEDDS for the oral delivery of rifampicin: Evaluation, proof of concept, in vivo kinetics, and in silico GastroPlusTM simulation
The present investigation was performed to develop a rifampicin (RIF)-loaded solidified self-nanoemulsifying drug delivery system (SNEDDS) (solidified RIF-OF1) for in vitro and in vivo evaluations.
Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy
Drug development for rare diseases is challenged by small populations and limited data.
Policy on Disclosure and Management of Financial Conflicts of Interest related to Public Health Service Research
Policy for disclosure & management of financial conflicts of interest related to PHS Research, with an issue date of the Notice of Award on or after August 24, 2012.
PMDA Adds Licenses of GastroPlus®
Japanese government organization to train reviewers to efficiently analyze PBPK model submissions
Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
Developing mathematical models to predict changes in ocular bioavailability and pharmacokinetics due to differences in the physicochemical properties of complex topical ophthalmic suspension formulations...
The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines
The recent impact of the Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific advancements is discussed.
U.S. FDA Renews DILIsym Software Licenses
U.S. FDA Remains Committed to Streamline & Accelerate Drug Development using Model-Informed Drug Development (MIDD) technology
How to obtain biowaivers for clinical trials using PBPK models, two case studies
FDA is open to proposals of using modeling approaches for bioequivalence (BE), or for new drugs,with the proper justification and model verification