Selatogrel is a potent, reversible, and selective antagonist of the platelet P2Y12 receptor currently developed for the treatment of acute myocardial infarction (AMI).
Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen
A bioequivalence study comparing two fixed dose combination tablets containing 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride showed bioequivalence for pseudoephedrine AUC and Cmax, but the reference product showed higher Cmax than the test product in fasted conditions.
Identification of phenylcarbamoylazinane-1,3,4-oxadiazole amides as lipoxygenase inhibitors with expression analysis and in silico studies
In search for new anti-inflammatory agents that inhibit the enzymes of arachidonic acid pathway as the drug targets, the present article describes the screening...
A novel chemical inhibitor suppresses breast cancer cell growth and metastasis through inhibiting HPIP oncoprotein
Increasing evidence suggests the pivotal role of hematopoietic pre-B-cell leukemia transcription factor (PBX)-interacting protein (HPIP/PBXIP1) in cancer development and progression...
Best practices in current models mimicking drug permeability in the gastrointestinal tract – an UNGAP review
The absorption of orally administered drug products is a complex, dynamic process, dependant on a range of biopharmaceutical properties; notably the aqueous solubility of a molecule, stability within the gastrointestinal tract (GIT) and permeability.
In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling
Recently, the development of Binder Jet 3D printing technology has promoted the research and application of personalized formulations, which are especially useful for children’s medications.
Exposure-Response Analysis to Support Nivolumab Once Every 4 Weeks Dosing in Combination with Cabozantinib in Renal Cell Carcinoma
A benefit:risk assessment for a less-frequent nivolumab 480 mg Q4W + cabozantinib 40 mg QD dosing regimen was predicted using modeling and simulation of clinical trial data from nivolumab monotherapy studies and
A supramolecular thermosensitive gel of ketoconazole for ocular applications: In silico, in vitro, and ex vivo studies
The incidence of corneal fungal infections continues to be a growing concern worldwide.
Predicting the Drug–Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation
The prediction of drug–drug interactions (DDIs) plays critical roles for the estimation of DDI risk caused by inhibition of CYP3A4.
Permeability of Gemcitabine and PBPK Modeling to Assess Oral Administration
Gemcitabine is a nucleoside analog effective against several solid tumors.
3D Printed Buccal Films for Prolonged-Release of Propranolol Hydrochloride: Development, Characterization and Bioavailability Prediction
Gelatin-polyvinylpyrrolidone (PVP) and gelatin-poly(vinyl alcohol) (PVA) mucoadhesive buccal films loaded with propranolol hydrochloride (PRH) were prepared by semi-solid extrusion 3D printing.
Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective
The International Consortium for Innovation and Quality (IQ) Physiologically Based Pharmacokinetic modeling (PBPK) Induction Working Group (IWG) conducted a survey across participating companies around general strategies for PBPK modeling of...
Stimuli to the Revision Process: The Case for Apex Vessels Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts
Apex vessels (previously known as PEAK vessels) are an important element of the dissoluton scientst's toolbox and are frequently used in pharmaceutcal drug product development setngs
Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia
Sodium oxybate (SXB) is a standard of care for cataplexy, excessive daytime sleepiness, and disrupted nighttime sleep in narcolepsy.
PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment
Pharmacokinetics (PK) is a branch of pharmacology present and of vital importance for the research and development (R&D) of new drugs, post-market monitoring, and continued optimizations in clinical contexts.
Ulcerogenic Activity in Pyrazolopyrimidine Derivatives in Lab and It’s In Silico Toxicity: An Update on Novel Research
Toxicity is a measure of any unfavourable or negative impact of substances.
Physiologically Based Pharmacokinetic Modeling and Dose Adjustment of Teicoplanin in Pediatric Patients With Renal Impairment
The pharmacokinetics of teicoplanin differs in children as compared with adults, and especially in renally impaired pediatric patients.
Foxm1 modulators and uses thereof
Disclosed herein, inter alia, are FOXM1 modulators and methods for modulating the activity of androgen receptors in neuronal cells to treat various diseases, such as spinal-...
Optimized In Silico Modeling of Drug Absorption after Gastric Bypass: The Case of Metformin
Bariatric surgery is an effective treatment for severe obesity and related comorbidities, such as type II diabetes. Gastric bypass surgery shortens the length of the intestine, possibly leading to altered drug absorption.
Prediction of pharmacokinetic parameters of inhaled indacaterol formulation in healthy volunteers using physiologically-based pharmacokinetic (PBPK) model
Inhaled formulations are the first choices for treating asthma and chronic obstructive pulmonary disease (COPD), attracting the increasing investment and development in the...