A multicenter study to evaluate the analytical precision by pathologists using the Aperio GT 450 DX.

Background: Digital pathology systems (DPS) are emerging as capable technologies for clinical practice. Studies have analyzed pathologists' diagnostic concordance by comparing reviews of whole slide images (WSIs) to glass slides (e.g.

Dose, exposure, and treatment regimen of intravenous immunoglobulin G in multifocal motor neuropathy.

Introduction: Intravenous immunoglobulin (IVIG) is the only approved treatment for multifocal motor neuropathy (MMN), a rare, chronic, immune-mediated demyelinating neuropathy. There is a significant gap in understanding of the role of serum immunoglobulin G (IgG) levels in the efficacy of IVIG in affected patients. We aimed to characterize the interplay between dose and exposure of IVIG and the effects of patient factors on individual variabilities.

Technological Barriers to Routine Genomic Surveillance for Vaccine Development Against SARS-CoV-2 in Africa: A Systematic Review.

The Global Initiative on Sharing All Influenza Data, a public-access database for sharing severe acute respiratory syndrome coronavirus 2 genomic sequencing data, has received significantly less data from African countries compared to the global total. Furthermore, the contribution of these data was infrequent and, for some countries, non-existent. The primary aim of this review is to identify the technological barriers to routine genomic surveillance in Africa.

Randomized Controlled Trial of the Immunogenicity and Safety of a Serum-Free Purified Vero Rabies Vaccine (PVRV-NG2) Using a Simulated Postexposure Zagreb Regimen With Human Rabies Immunoglobulin in Adults in Thailand.

Background: A serum-free, highly purified Vero rabies vaccine-next generation (PVRV-NG2) is under development. We conducted a phase III trial to describe the safety and immunogenicity profile of PVRV-NG2 compared with those of licensed purified Vero rabies vaccine (PVRV) in a simulated rabies postexposure prophylaxis (PEP) Zagreb regimen in Thailand.

Methods: Healthy adults aged ≥18 years (n = 201) were randomized in a 2:1 ratio to receive PVRV-NG2 or PVRV in a rabies PEP Zagreb (days 0, 7, 21 [2-1-1]) regimen, with concomitant human rabies immunoglobulin (HRIG) at day 0.

The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab.

The accelerated approval (AA) pathway was established by the United States Food and Drug Administration (FDA) to provide earlier access to therapies for patients with serious medical conditions and unmet medical needs. Since its inception, the AA pathway has been used for novel treatments across different therapeutic areas, but most prominently in oncology, including the immune checkpoint inhibitor class. This review article describes the history of regulatory approvals for pembrolizumab, an immunotherapy agent targeting programmed death receptor-1 (PD-1), and use of the AA pathway and the corresponding regulatory decisions made by the FDA.

Brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease: A 12-week, active-treatment, extension trial.

Background: A 12-week randomized controlled trial demonstrated that brexpiprazole is efficacious for treating agitation in patients with dementia due to Alzheimer's disease.

Objective: To assess the long-term safety and tolerability of brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease.

Methods: This 12-week, active-treatment (oral brexpiprazole 2 or 3 mg/day) extension trial ran from October 2018-September 2022 at 66 sites in Europe/US.

Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study.

Unlabelled: The fixed-dose combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) delivered pressurised metered-dose inhaler (pMDI) has demonstrated efficacy in chronic obstructive pulmonary disease (COPD), in studies predominantly conducted in Caucasian adults. The current study evaluated the efficacy and safety of BDP/FF pMDI in Chinese patients with COPD, as part of registration for COPD in China. This double-blind, double-dummy, randomised, parallel-group study was conducted in patients with COPD of Chinese ethnicity aged ≥40 years.

Reporting ethical approval in case reports and case series in 12 consecutive years: A systematic review.

Our study describes the reported rate of the Institutional Review Board (IRB) approval, declaration of Helsinki (DoH), and informed consent in the case reports and case series and investigates factors associated with the ethical approval report. We searched PubMed for case reports and case series from 2006 to 2017. Annually, we obtained the first 20 articles of a case report cluster from 20 distinct publications.

The reference value of serum vitamin B12 among An-Najah National University.

Background: Serum vitamin B12 plays a crucial role in cellular growth, DNA synthesis, and maintaining a healthy nervous system. Its deficiency can lead to various health issues, including cardiovascular problems. The reference range for vitamin B12 varies between populations due to cultural, genetic, and dietary differences.

TAVI complication: Prosthetic valve leaflet dislodgment after post-dilatation.

Introduction And Importance: Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat severe aortic stenosis. While TAVI is generally safe and effective, it can be complicated by rare adverse events such as prosthetic leaflet dislodgment leading to acute free aortic regurgitation.

Case Presentation: We report the case of a female patient who experienced acute free aortic regurgitation following elective TAVI.

Effects of inhaled beclometasone dipropionate/formoterol fumarate/glycopyrronium vs. beclometasone dipropionate/formoterol fumarate and placebo on lung hyperinflation and exercise endurance in chronic obstructive pulmonary disease: a randomised controlled trial.

Background: The single-inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) is available for maintenance therapy of chronic obstructive pulmonary disease (COPD). Cardinal features of COPD are lung hyperinflation and reduced exercise capacity. TRIFORCE aimed to evaluate the effect of BDP/FF/G on lung hyperinflation and exercise capacity in patients with COPD.

Bioequivalence requirements for orally inhaled and nasal drug products and use of novel physiologically based biopharmaceutics modeling approaches for assessing in vivo performance.

Orally inhaled and nasal drug products (OINDPs) are complex due to the interplay between the device, formulation, and patient characteristics. Establishing bioequivalence (BE) of OINDPs with reference is highly complex and require in vitro, in vivo pharmacokinetic and comparative clinical endpoint studies that are challenging to conduct. In order to increase the rate of submission and approval of generics, regulatory agencies are encouraging the use of alternative in vitro and in silico methodologies to replace complex in vivo studies.

Examining the clinical outcomes of a soft silicone multilayer foam dressing for exudate management in US hospitals: it is time to optimize dressing change frequency.

Background: Acute and chronic wounds in the acute hospital setting are commonly managed with soft silicone multilayer foam dressings (SSMFDs). While many SSMFDs are indicated for wear time of up to 7 days, they are often changed more frequently.

Objective: To use real-world data on dressing change practices and clinical outcomes to examine whether a built-in indicator on a proprietary SSMFD could reduce unnecessary dressing changes.

A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward.

Purpose: In silico modeling and simulation techniques such as physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) have demonstrated various applications in drug discovery and development. Virtual bioequivalence leverages these computation tools to predict bioequivalence between reference and test formulations thereby demonstrating possibilities to reduce human studies. A pre-requisite for virtual bioequivalence is development of validated virtual population that depicts the same variability as that of observed in clinic.

Justification of widened dissolution specifications of an extended-release product using physiologically based biopharmaceutics modeling.

Drug products meeting the dissolution specifications is crucial in order to ensure consistent clinical performance. However, in certain cases, wider dissolution specifications may be required based on product behaviour. While the justification of such wider specifications may be challenging from a regulatory context, approaches such as physiological-based biopharmaceutics modeling (PBBM) can be utilised for this purpose.

Real-world use of inhaled corticosteroid/formoterol as needed in adults with mild asthma: the PRIME study.

Introduction: Inhaled corticosteroid/formoterol fumarate (ICS/FF) as needed is recommended by the Global Initiative for Asthma (GINA) as sole therapy in adults with mild asthma, with low-dose maintenance ICS plus short-acting β-agonist (SABA) as an alternative. SABA alone is no longer recommended. Given these changes in recommendations, the observational PRIME study aimed to describe real-world treatment patterns in mild asthma in Europe.