Acute myeloid leukemia (AML) is a type of leukemia with an aggressive phenotype, that commonly occurs in adults and with disappointing treatment outcomes.
Saliva Sampling in Therapeutic Drug Monitoring and Physiologically Based Pharmacokinetic Modeling: Review
Therapeutic drug monitoring investigations based on saliva samples can be utilized as an alternative to blood sampling for many advantages.
Use of Gastrointestinal Simulator, Mass Transport Analysis, and Absorption Simulation to Investigate the Impact of pH Modifiers in Mitigating Weakly Basic Drugs’ Performance Issues Related to Gastric pH: Palbociclib Case Study
It is well known that reduced gastric acidity, for example with concomitant administration of acid reducing agents, can result in variable pharmacokinetics and decreased...
In vitro and in vivo evaluation of the main protease inhibitor FB2001 against SARS-CoV-2
FB2001 is a drug candidate that targets the main protease of SARS-CoV-2 via covalently binding to cysteine 145.
Predicting the correct dose in children: Role of computational Pediatric Physiological-based pharmacokinetics modeling tools
The pharmacokinetics (PKs) and safety of medications in particular groups can be predicted using the physiologically-based pharmacokinetic (PBPK) model.
First-in-human study to investigate the safety and pharmacokinetics of salvianolic acid A and pharmacokinetic simulation using a physiologically based pharmacokinetic model
Salvianolic acid A (SAA) is a water-soluble phenolic acid component from Salvia miltiorrhiza Bunge currently under development for myocardial protection treatment for coronary heart disease (CHD).
Formulation of metoclopramide HCl gastroretentive film and in vitro- in silico prediction using Gastroplus® PBPK software
The new trends in pharmaceutical studies focus on targeting drug delivery and computer software that help in the body environment simulation, such as Gastroplus® software.
Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union
Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in theEuropean Union is currently established by demonstrating that the 90% confidence interval for theratio of the population geometric...
Inferring Therapeutic Targets in Candida albicans and Possible Inhibition through Natural Products: A Binding and Physiological Based Pharmacokinetics Snapshot
Despite being responsible for invasive infections, fungal pathogens have been underrepresented in computer aided therapeutic target mining and drug design.
Development of physiologically based pharmacokinetics model for prediction of drug disposition in diabetic patients
Background: There is growing evidence that diabetes mellitus modifies the pharmacokinetics of several medications, changing their pharmacodynamics.
A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms
Atorvastatin is the most prescribed 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor used to lower cardiovascular risk and constitutes one of the best-selling drugs world-wide.
Absorption, distribution, metabolism, and excretion of [14C]Mefuparib (CVL218), a novel PARP1/2 inhibitor, in rats
Mefuparib (CVL218) is a novel second-generation poly-ADP-ribose polymerase (PARP) inhibitor for cancer treatment.
Physiologically based pharmacokinetic modeling and simulation of cannabinoids in human plasma and tissues
There has been an increased public interest in developing consumer products containing nonintoxicating cannabinoids, such as cannabidiol (CBD) and cannabigerol (CBG).
Utility of preclinical species for uncertainty assessment and correction of prediction of human volume of distribution using the Rodgers-Lukacova model
Prediction of rat, dog, monkey, and human volume of distribution (VDss) by Rodgers-Lukacova model was evaluated using a data set of more than 100 compounds.
The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage forms for which...
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme
The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product...
In vitro antibacterial activity and in vivo pharmacokinetics of intravenously administered Amikacin-loaded Liposomes for the management of bacterial septicaemia
Systemic delivery of amikacin is a widely adopted treatment modality for severe infections like sepsis. However, the current course of treatment requires repeated bolus doses of amikacin, prolonged hospitalization, and continuous therapeutic monitoring to manage the severe adverse effects.
SeDeM tool-driven full factorial design for osmotic drug delivery of tramadol HCl: Formulation development, physicochemical evaluation, and in-silico PBPK modeling for predictive pharmacokinetic evaluation using GastroPlus™
An elementary osmotic pump (EOP) is the simplest form of osmotic drug delivery system that consists of the combination of active pharmaceutical ingredients and excipients...
Population pharmacokinetic modeling of daridorexant, a novel dual orexin receptor antagonist
The analysis aimed at identifying subject-specific characteristics (covariates) influ-encing exposure to daridorexant and quantification of covariate effects to determineclinical relevance.
Prediction of janagliflozin pharmacokinetics in type 2 diabetes mellitus patients with liver cirrhosis or renal impairment using a physiologically based pharmacokinetic model
Janagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor for type 2 diabetes mellitus (T2DM).