Mixture Experimentation in Pharmaceutical Formulations: A Tutorial.

Mixture experimentation is commonly seen in pharmaceutical formulation studies, where the relative proportions of the individual components are modeled for effects on product attributes. The requirement that the sum of the component proportions equals 1 has given rise to the class of designs, known as mixture designs. The first mixture designs were published by Quenouille in 1953 but it took nearly 40 years for the earliest mixture design applications to be published in the pharmaceutical sciences literature by Kettaneh-Wold in 1991 and Waaler in 1992.

A Bayesian Approach to Kinetic Modeling of Accelerated Stability Studies and Shelf Life Determination.

Kinetic modeling of accelerated stability data serves an important purpose in the development of pharmaceutical products, providing support for shelf life claims and expediting the path to clinical implementation. In this context, a Bayesian kinetic modeling framework is considered, accommodating different types of nonlinear kinetics with temperature and humidity dependent rates of degradation and accounting for the humidity conditions within the packaging to predict the shelf life. In comparison to kinetic modeling based on nonlinear least-squares regression, the Bayesian approach allows for interpretable posterior inference, flexible error modeling and the opportunity to include prior information based on historical data or expert knowledge.

One-year Follow-up Results of Transperineal Biopsy For Patients Undergoing Irreversible Electroporation Treatment in Localized Prostate Cancer.

Objective: This article reports on the early results of a 1-year follow-up study investigating the efficacy of irreversible electroporation in the treatment of localized prostate cancer.

Methods: The study included 18 out of 40 patients diagnosed with low- and intermediate-risk prostate cancer who underwent irreversible electroporation. Treatment results were evaluated through confirmation biopsies, comparing prostate-specific antigen levels, international prostate symptom scoring, and international index of erectile dysfunction scores before irreversible electroporation and at the 12-month mark.

Stability analysis using mixed models: A critique of tolerance interval methods and a probabilistic solution.

Recently, tolerance interval approaches to the calculation of a shelf life of a drug product have been proposed in the literature. These address the belief that shelf life should be related to control of a certain proportion of batches being out of specification. We question the appropriateness of the tolerance interval approach.

DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.

The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product decisions as part of drug product life cycle management. Accordingly, the application of mathematical approaches to evaluate dissolution profile similarity is described in regulatory guidance with the emphasis given to the similarity factor f with little discussion of alternative methods. In an effort to highlight current practices to assess dissolution profile similarity and to strive toward global harmonization, a workshop entitled "In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, When" was held on May 21-22, 2019 at the University of Maryland, Baltimore.

Evaluation of clinical and mpMRI findings of irreversible electroporation therapy for the treatment of localized prostate cancer: Preliminary results.

Objective: To evaluate early clinical and multiparametric prostate magnetic resonance imaging (mpMRI) results of irreversible electroporation (IRE) efficiency in treatment of localized prostate cancer.

Material And Methods: For the patients in whom IRE was performed for local ablation, mpMRI was used for the sixth month follow-up. These images were compared with the mpMRI images obtained before the procedure.

Adaptation of the Dementia Attitudes Scale into Turkish.

Introduction: The aim of this study was to assess psychometric properties of the Turkish version of the Dementia Attitudes Scale which is developed to determine attitudes towards dementia.

Methods: 326 volunteered students between the age of 20-44 years, studying in Manisa Celal Bayar University Faculty of Medicine and Faculty of Health Sciences are included in this methodological study. Data of the study were collected with "Demographic Data Form", "Dementia Attitudes Scale" and "UCLA-Geriatrics Attitudes Scale".

Factors that predict the perception of spirituality and spiritual care of nurses working in high-risk units and the effect of death anxiety.

Purpose: Spirituality contributes to the health and well-being of individuals. This study investigates the factors that predict the spirituality perceptions and the effect of death anxiety of nurses.

Design And Methods: This was a cross-sectional study, 382 nurses working in four public hospitals intensive care and emergency departments setting in two different cities in Turkey.

The Reflections of Final Year Medical Students About Nursing Home: "Loneliness and Abandonment".

Background: Population aging is a global phenomenon with opportunities and challenges. The numbers and proportions of older people are increasing in almost every country. This study aimed to evaluate the perceptions of nursing homes among final-year medical students.

Impact of bacterial translocation in calves with atresia coli.

Objective: To identify whether enteric bacteria pass into the mesenteric lymph nodes (MLNs) and peritoneal cavity in calves with atresia coli and to evaluate whether the presence of bacterial translocation (BT) has an impact on the success of surgical treatment.

Design: Prospective clinical study.

Animals: Twenty-six client-owned calves.

Topical dimethyl sulfoxide inhibits corneal neovascularization and stimulates corneal repair in rabbits following acid burn.

Neovascularization of the cornea is characterized by the growth of blood vessels caused by imbalances between angiogenic and anti-angiogenic factors. We investigated whether the expression of Vascular endothelial growth factor (VEGF), Vascular endothelial growth factor receptor (VEGF), Vascular endothelial growth inhibitor (VEGI) receptors, as well as topical drug treatments, participate in regulating corneal neovascularization after corneal damage and remodeling. We used 72 mature male New Zealand rabbits.

Dimethyl sulfoxide but not indomethacin is efficient for healing in hydrofluoric acid eye burns.

Introduction: In this study, we aimed to investigate the effect of indomethacin and dimethyl sulfoxide (DMSO), well-known antioxidant and anti-inflammatory agents, to heal eye burns induced with hydrofluoric acid in rabbits.

Methods: After general anesthesia, the right eye of 72 male New Zealand rabbits were burned by instillation of 2% hydrofluoric acid for 60s. Following this, the eyes were irrigated with 500 cc normal saline.

Effects of neurofeedback therapy in healthy young subjects.

Purpose: Neurofeedback refers to a form of operant conditioning of electrical brain activity, in which desirable brain activity is rewarded and undesirable brain activity is inhibited. The research team aimed to examine the efficacy of neurofeedback therapy on electroencephalogram (EEG) for heart rate, electrocardiogram (ECG) and galvanic skin resistance (GSR) parameters in a healthy young male population.

Methods: Forty healthy young male subjects aged between 18 to 30 years participated in this study.

Plasma and synovial fluid pharmacokinetics of cefquinome following the administration of multiple doses in horses.

The plasma and synovial fluid pharmacokinetics and safety of cefquinome, a 2-amino-5-thiazolyl cephalosporin, were determined after multiple intravenous administrations in sixteen healthy horses. Cefquinome was administered to each horse through a slow i.v.

Psychometric properties of the Turkish version of the Emotional Eating Scale for children and adolescents.

This methodological-descriptive-sectional study was performed to assess the validity and reliability of the "Emotional Eating Scale Adapted for Use in Children and Adolescents (EES-C)" scale in Turkey. The sample group of the study was composed of 576 children and adolescents. The data were obtained by using the demographic data collection form and "Emotional Eating Scale Adapted for Use in Children and Adolescents (EES-C)".

Psychometric Properties of Turkish Version of Pediatric Daytime Sleepiness Scale (PDSS-T).

Purpose: The aim of the research was to evaluate the psychometric properties of the Pediatric Daytime Sleepiness Scale-Turkish Version (PDSS-T).

Methods: The researchers chose a study sample of 522 grade 5-11 students. Data were collected using a demographic data collection form and the PDSS-T.

Effects of perceived smoking-cancer relationship and cardiovascular health attitudes on childrens' views of smoking.

Background: This study was conducted with the aim of determining how students' perceived smoking-cancer relationship and cardiovascular health attitudes affect childrens' views of smoking.

Materials And Methods: The sample of this descriptive-cross sectional study comprised 574 subjects between the ages of 11-15. The data were collected using the Children's Cardiovascular Health Promotion Attitude Scale and the Children's Decisional Balance Measure for Assessing and Predicting Smoking Status.

Dissolution curve comparisons through the F(2) parameter, a Bayesian extension of the f(2) statistic.

Dissolution (or in vitro release) studies constitute an important aspect of pharmaceutical drug development. One important use of such studies is for justifying a biowaiver for post-approval changes which requires establishing equivalence between the new and old product. We propose a statistically rigorous modeling approach for this purpose based on the estimation of what we refer to as the F2 parameter, an extension of the commonly used f2 statistic.

An application of serially balanced designs for the study of known taste samples with the α-ASTREE electronic tongue.

The α-ASTREE e-Tongue instrument uses seven sensors to characterize taste signals associated with a liquid sample. The instrument was used to study eight test preparations (comprised of a blank, four preparations corresponding to four known tastes and Sodium Topiramate in three concentrations known to have a bitter taste) and eight washes. Serially balanced residual effects designs were used to order the samples to estimate residual and main effects.

Block designs in method transfer experiments.

Method transfer is a part of the pharmaceutical development process in which an analytical (chemical) procedure developed in one laboratory (typically the research laboratory) is about to be adopted by one or more recipient laboratories (production or commercial operations). The objective is to show that the recipient laboratory is capable of performing the procedure in an acceptable manner. In the course of carrying out a method transfer, other questions may arise related to fixed or random factors of interest, such as analyst, apparatus, batch, supplier of analytical reagents, and so forth.

Double bootstrapping a tolerance limit.

We consider the problem of constructing tolerance limits in the context of a one-way random effects model The usual parametric method for calculating tolerance intervals is based on the normality assumption. However, in practice, we frequently observe nonnormally distributed data. We propose the use of the double bootstrap (or nested bootstrap) method to estimate tolerance limits, which allows us to relax the normality assumption.

Serially balanced designs for two sets of treatments.

Serially balanced designs are useful in applications in which repeated measurements of multiple samples (treatments) are being taken according to an ordered sequence. The design permits the estimation of direct treatment and carryover effects. When the samples comprise two groups, where the sequence requires samples from one group to be separated by samples from another group (e.

A note on kinetic modeling of stability data and implications on pooling.

In this note we discuss the relationship between the underlying kinetic model and the statistical (or analytic) model used to study degradation. For small degradation rates, the zeroth, first, and second order statistical models give approximately the same fits and predictions on either the original assay scale or the percent of label claim scale. However, It is shown that the zeroth and second order statistical models artificially induce differential degradation rates across strengths when the percent of label claim response data are analyzed and poolability is not allowed across strengths.

A distal protruding ureteral polyp looking like a bladder mass.

A 34-year-old female patient with a right lumbar and back pain during micturition is presented. Ultrasonography and intravenous urogram both supported a possible bladder mass. Finally, a ureteral polyp was diagnosed on cystoscopy and resected by the ureteroscopic approach.