The objectives were to define the maximum tolerated dose (MTD), safety profile and pharmacokinetics (PKs) of intraperitoneal oxaliplatin delivered by pressurized intraperitoneal...
Development of physiologically-based pharmacokinetic models for standard of care and newer tuberculosis drugs
Tuberculosis (TB) remains a global health problem and there is an ongoing effort to develop more effective therapies and new combination regimes that can reduce duration of treatment.
Pharmacokinetics of Baclofen in a Full-Term Newborn after Intrauterine Exposure: A Case Report
Intrauterine exposure to baclofen can lead to syndrome of withdrawal during the first days of the newborn.
A new phenothiazine derivate is active against Clostridioides difficile and shows low cytotoxicity
The rapid evolution of antibiotic resistance in Clostridioides difficile and the consequent effects on prevention and treatment of C.
Slower degradation rate of cytarabine in blood samples from acute myeloid leukemia by comparison with control samples
Cytarabine, a key chemotherapy agent for acute myeloid leukemia (AML) treatment, is deaminated into inactive uracil-arabinoside by cytidine deaminase.
Dose Selection for Fremanezumab (AJOVY) Phase 3 Pediatric Migraine Studies Using Pharmacokinetic Data From a Pediatric Phase 1 Study and a Population Pharmacokinetic Modeling and Simulation Approach
Potential fremanezumab doses for pediatric patients were evaluated using pharmacokinetic modeling and
Pharmacokinetics of Pantoprazole and Pantoprazole Sulfone in Goats After Intravenous Administration: A Preliminary Report
Ruminant species are at risk of developing abomasal ulceration, but there is a lack of pharmacokinetic data for anti-ulcer therapies, such as the proton pump inhibitor pantoprazole, in...
Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms Using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption.
Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption.
Integrated Testing Strategy for the Safety of Botanical Ingredients: A Case Study with German Chamomile Constituents
Introduction: chamomile is a botanical ingredient commonly used in cosmetics, thus determination of skin sensitization effects of German chamomile constituents is critical for the...
Comparison of in vitro, in vivo, and in silico bioavailability results of different prednisone tablet formulations to assess the feasibility of possible biowaiver
The immediate-release solid oral products containing very soluble and permeable drugs are candidates for the biowaiver process.
Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Evaluate the Absorption of Midazolam Rectal Gel
We aimed to 1) develop physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models of a novel midazolam rectal gel in healthy adults, 2) assess the contribution of different physiologically relevant...
Integration of Clinical and Scientific Principles in the Teaching of Drug-Drug Interactions
Evaluation of drug-drug interactions (DDIs) is an integral part of pharmacy practice worldwide.
Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities
The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) on the different criteria used for biosimilar development and marketing authorisation process.
Physiologically Based Pharmacokinetic Modelling of Inhaled Nemiralisib: Mechanistic Components for Pulmonary Absorption, Systemic Distribution, and Oral Absorption
Physiologically based pharmacokinetic (PBPK) modelling has evolved to accommodate different routes of drug administration and enables prediction of drug concentrations in tissues as well as plasma.
Development of PBPK model for intra-articular injection in human: methotrexate solution and rheumatoid arthritis case study
A physiologically based model describing the dissolution, diffusion, and transfer of drug from the intra-articular (IA) space to the plasma, was developed for GastroPlus v9.8.
Current computer-aided drug design methodologies in discovery of novel drug candidates for neuropsychiatric and inflammatory diseases
Drug discovery and development is a very challenging, expensive and time-consuming process.
The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development
Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications.
Pharmacokinetics of tulathromycin in pregnant ewes (Ovis aries) challenged with Campylobacter jejuni
The purpose of this study was to evaluate the pharmacokinetics of tulathromycin in the plasma and maternal and fetal tissues of pregnant ewes when administered within 24 hours of a...
Improving Dissolution Behavior and Oral Absorption of Drugs with pH-Dependent Solubility Using pH Modifiers: A Physiologically Realistic Mass Transport Analysis
Orally dosed drugs must dissolve in the gastrointestinal (GI) tract before being absorbed through the epithelial cell membrane.