Triplice formula

Purpose : To characterize the effect of glasdegib on cardiac repolarization (QTc) in patients with advanced cancer. Methods : A concentration-QTc model was developed using data from two glasdegib single-agent, dose-escalation trials. Triplicate electrocardiogram was performed at pre-specified timepoints paired with pharmacokinetic blood collections after a single dose and at steady-state. Changes in QTc from baseline were predicted by model-based simulations at the clinical dose (100 mg QD) and in a supratherapeutic setting...

AIMS/HYPOTHESIS: In individuals with type 1 diabetes, chronic hyperglycaemia impairs aerobic fitness. However, the effect of acute marked hyperglycaemia on aerobic fitness is unclear, and the impact of insulin level has not been examined. In this study, we explored if acute hyperglycaemia with higher or low insulin levels affects [Formula: see text] and other exercise performance indicators in individuals with type 1 diabetes. METHODS: Eligible participants were aged 14 to 30 years, with complication-free, type 1 diabetes and HbA1c  ≤ 75 mmol/mol (≤9%)...

OBJECTIVE: The administration of hyperosmolar oral products in neonates has been associated with gastrointestinal complications. The American Academy of Pediatrics recommends a maximum osmolality of 450 mOsm/kg for formulas and enteral nutrition for term infants, and recent studies reported intolerance to enteral nutrition with osmolality above 500 mOsm/kg in low birthweight infants. The osmolality of medications administered to neonates is often not available in the literature or from manufacturers...

OBJECTIVE: To evaluate the anti-apoptotic efficacy of Qingnao Yizhi formula (，QNYZ) in cultured cerebral cortical neuronal cells (CNCs) and the regulation of the NogoA-Nogo receptor (NgR)/Rho-Rho kinase (ROCK) signaling pathway. METHODS: Primary cultured CNCs were randomly divided into the following groups: normal control group (N-C), hypoxia-reoxygenation group (H/R), high-dose QNYZ group (Q-H), low-dose QNYZ group (Q-L) butylphthalide (NBP) group, and Y-27632 (a selective ROCK transduction pathway inhibiter) group...

INTRODUCTION: Daratumumab is a CD38-targeting monoclonal antibody that has demonstrated clinical benefit for multiple myeloma. Daratumumab inhibition of CD38, which is expressed on immune cell populations and cardiomyocytes, could potentially affect cardiac function. This QTc substudy of the phase 2 CENTAURUS study investigated the potential effect of intravenous daratumumab monotherapy on QTc prolongation and other electrocardiogram (ECG) parameters, including concentration-QTc effect modeling...

Characterization of antibody-drug conjugates (ADCs) using mass spectrometry (MS) is important in drug discovery and formulation development and as part of the quality control processes. To facilitate electrospray ionization (ESI) and produce high-quality mass spectra, common components of storage solutions for monoclonal antibodies (mAbs) and ADCs, such as nonvolatile phosphate-buffered saline (PBS), should be replaced before analysis. Centrifugal spin-type kits are extensively used for the desalting or buffer-exchange of mAbs and ADCs samples...

INTRODUCTION AND OBJECTIVES: The fortification of maternal milk (MM) is a standard practice in order to achieve the requirements needed for the growth and development of the premature newborn. However, its osmolality could increase. According to the American Paediatrics Academy, it is recommended not to exceed 450 mOsm/kg (approximately 400 mOsm/L) in the diet of the infant, even though the safety limit is estimated to be between 400 and 600 mOsm/kg. The aim of this study is to determine the osmolality of thawed and fortified donated MM (DMM)...

The effect of steady-state supratherapeutic sertraline (Zoloft) on QT interval was assessed in a single-center, randomized, 3-way crossover, double-blind, placebo- and moxifloxacin-controlled thorough QT study. Healthy adults received sertraline 400 mg/day, moxifloxacin 400 mg, and placebo, with a washout period (≥14 days) between treatments. A 12-lead electrocardiogram was recorded in triplicate before dosing and at selected time points up to 72 hours after dosing. Analysis of covariance using a mixed-effect model with sequence, period, treatment, time, and treatment-by-time interaction as fixed effects; subject within sequence as a random effect; and baseline QT corrected for heart rate using Fridericia formula (QTcF) as a covariate was conducted...

Objective: this study aims to investigate the physical stability of standard formulations for parenteral nutrition, with and without lipids, in one bag for preterm babies. Method: standard formulations for first-day and for second-day parenteral nutrition of preterm babies weighing 1,000 grams were prepared in triplicate. Standard all-in-one formulas for first-day and for second-day parenteral nutrition were compared with equivalent standard lipid-free formulations. The standard formulas contain glucose, lipids, calcium gluconate, potassium chloride, sodium chloride, and vitamins...

The incorporation of antimicrobials in the composites as an attempt to reduce bacterial adhesion without jeopardizing mechanical properties is a challenge for Dentistry. OBJECTIVE To evaluate the bacterial adhesion and physical properties of a composite containing the methacrylate triclosan- derivative monomer (TM). METHODOLOGY TM was synthesized and added to an experimental composite. Samples were divided into two groups: Control and TM (13.4 wt%). Antibacterial Activity: Three specimens of each material were prepared and placed on bacterial suspensions of Streptococcus mutans for 1, 5 and 10 days...

The aims of this study were (i) to evaluate the effect of talazoparib (1 mg once daily) on cardiac repolarization in patients with advanced solid tumors by assessing corrected QT interval (QTc) and (ii) to examine the relationship between plasma talazoparib concentration and QTc. In this open-label phase 1 study, patients had continuous 12-lead ECG recordings at baseline followed by time-matched continuous ECG recordings and collection of talazoparib plasma pharmacokinetic samples predose and at 1, 2, 4, and 6 h postdose on treatment days 1 and 22 and before talazoparib administration on day 2...

INTRODUCTION: The present analysis addressed the effect of the number of ECG replicates extracted from a continuous ECG on estimated QT interval prolongation for different QT correction formulas. METHODS: For one hundred healthy volunteers, who received a compound prolonging the QT interval, 18 ECG replicates within a 3 minute window were extracted from 12-lead Holter ECGs. Ten QT correction formulas were deployed and the QTc interval was controlled for baseline and placebo and averaged per dose level...

PURPOSE: Anticancer drugs may cause cardiovascular toxicities, including QT interval prolongation. Niraparib, a potent and selective once-daily oral poly (ADP-ribose) polymerase inhibitor, is approved as a maintenance therapy in platinum-sensitive recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC). Here, we present the effects of niraparib on cardiac repolarization, and the correlation between changes in baseline QT interval corrected by Fridericia's formula (ΔQTcF) and niraparib plasma concentrations...

The present study was conducted to evaluate the effect of two new formulas of dietary buffers on intake, total tract digestibility, rumen pH, blood metabolites, and milk production of mid-lactation dairy cows. Nine multiparous cows (594 ± 46 kg BW; mean ± SD) averaging 120 ± 28 days in milk and producing 46.6 ± 3.4 kg/d were randomly assigned to a triplicate 3 × 3 Latin square. During each 21-d period, cows were offered one of three total mixed rations that varied in dietary buffer...

AIM: To characterize the effect of inotuzumab ozogamicin on QT interval in patients with B-cell malignancies. METHODS: Data were pooled from three clinical studies including 250 patients (N=2743) who received inotuzumab ozogamicin monotherapy. Patients with relapsed/refractory acute lymphoblastic leukaemia (NCT01564784 and NCT01363297) received 1.8 mg m-2 per cycle in divided doses (mean Cmax 371 ng ml-1 ; considered therapeutic) and patients with relapsed/refractory non-Hodgkin lymphoma (NCT00868608) received 1...

BACKGROUND: Many healthcare facilities and providers prohibit blenderized tube feeding (BTF) for patients who request it due to concerns of high microbial load. The current project compared microbial loads of a standard ready-to-feed polymeric commercial formula (CF), a BTF made using baby food (BTF-BF), and a BTF prepared from blending whole food (BTF-WF), following food safety standards expected of U.S. hospitals. METHODS: Three tube-feeding formulas (CF, BTF-BF, BTF-WF) were prepared in a U...

OBJECTIVE: To analyze the influence of dilution, time, and temperature after preparation on the osmolality of infant formulas given to newborns (NBs). METHODS: Experimental and descriptive study with samples of different neonatal formulas to verify the osmolality of the milk according to dilution, time, and temperature after preparation. We analyzed seven neonatal formulas in the following times after preparation: immediately (up to 5 minutes); 20 and 40 minutes; every hour up to 8 hours; and 12 and 24 hours...

The Biscayne Bay Coastal Wetlands (BBCW) project of the Comprehensive Everglades Restoration Plan (CERP) aims to reduce point-source freshwater discharges and spread freshwater flow along the mainland shoreline of southern Biscayne Bay. These actions will be taken to approximate conditions in the coastal wetlands and bay that existed prior to construction of canals and water control structures. An increase in pink shrimp (Farfantepenaeus duorarum) density to ≥ 2 individuals m-2 during the wet season (i.e...

Purpose: Individuals approaching presbyopia may exhibit ocular symptoms as they contend with visual demands of near work, coupled with natural age-related changes in accommodation. Therefore, accommodation and vergence of 30- to 40-year-old, myopic, soft contact lens wearing subjects with symptoms of asthenopia and no history of using multifocal lenses were evaluated. Patients and methods: In this prospective, observational study, 253 subjects with asthenopia were evaluated by 25 qualified practitioners, each at a different clinical site...

The present study investigated the capabilities and performances of semi-continuous and fully-continuous probabilistic approaches to DNA mixtures interpretation, particularly when dealing with Low-Template DNA mixtures. Five statistical interpretation software, such as Lab Retriever and LRmix Studio - involving semi-continuous algorithms - and DNA•VIEW® , EuroForMix and STRmixTM - employing fully-continuous formulae - were employed to calculate likelihood ratio, comparing the prosecution and the defense hypotheses relative to a series of on-purpose prepared DNA mixtures that respectively contained 2 and 3 known contributors...