A Meta-Analysis of the Safety and Immunogenicity of Pharmacokinetic Similarity Studies and Comparative Clinical Studies.

A biosimilar clinical development program generally includes a pharmacokinetic similarity study and a comparative clinical study. Since both types of studies assess safety and immunogenicity, it is important to evaluate the role of each in determining whether there are any meaningful differences between the proposed biosimilar products and the reference products. We conducted a systematic review and meta-analysis of the safety and immunogenicity data from pharmacokinetic similarity studies and comparative clinical studies, using a database of approved monoclonal antibody and fusion protein biosimilars.

An Image Processing Approach to Quality Control of Drop-on-Demand Electrohydrodynamic (EHD) Printing.

Droplet quality in drop-on-demand (DoD) Electrohydrodynamic (EHD) inkjet printing plays a crucial role in influencing the overall performance and manufacturing quality of the operation. The current approach to droplet printing analysis involves manually outlining/labeling the printed dots on the substrate under a microscope and then using microscope software to estimate the dot sizes by assuming the dots have a standard circular shape. Therefore, it is prone to errors.

G-quadruplexes in long non-coding RNAs and their interactions with proteins.

Long non-coding RNAs (lncRNAs) have emerged as crucial regulators of cellular processes, with their dysregulation linked to various disease states. Among the structural motifs in lncRNAs, RNA G-quadruplexes (rG4s) have gained increasing attention due to their diverse roles in cellular function and disease pathogenesis. This review provides an updated and comprehensive overview of rG4s in lncRNAs, elucidating their formation, interaction with proteins, and distinctive roles in cellular processes.

Feasibility and Advantages of Continuous Synthesis of Bioinspired Silica Using CO as an Acidifying Agent.

In this work, we present a method for the continuous synthesis of bioinspired porous silica (BIS) particles using carbon dioxide (CO) as an acidifying agent. Typical BIS synthesis uses strong mineral acids (e.g.

Prosapip1 in the dorsal hippocampus mediates synaptic protein composition, long-term potentiation, and spatial memory.

Prosapip1 is a brain-specific protein localized to the postsynaptic density, where it promotes dendritic spine maturation in primary hippocampal neurons. However, nothing is known about the role of Prosapip1 . To examine this, we utilized the Cre-loxP system to develop a Prosapip1 neuronal knockout mouse.

The Small G-Protein Rac1 in the Dorsomedial Striatum Promotes Alcohol-Dependent Structural Plasticity and Goal-Directed Learning in Mice.

The small G-protein Ras-related C3 botulinum toxin substrate 1 (Rac1) promotes the formation of filamentous actin (F-actin). Actin is a major component of dendritic spines, and we previously found that alcohol alters actin composition and dendritic spine structure in the nucleus accumbens (NAc) and the dorsomedial striatum (DMS). To examine if Rac1 contributes to these alcohol-mediated adaptations, we measured the level of GTP-bound active Rac1 in the striatum of mice following 7 weeks of intermittent access to 20% alcohol.

A Mechanically Resilient Soft Hydrogel Improves Drug Delivery for Treating Post-Traumatic Osteoarthritis in Physically Active Joints.

Intra-articular delivery of disease-modifying osteoarthritis drugs (DMOADs) is likely to be most effective in early post-traumatic osteoarthritis (PTOA) when symptoms are minimal and patients are physically active. DMOAD delivery systems therefore must withstand repeated mechanical loading without affecting the drug release kinetics. Although soft materials are preferred for DMOAD delivery, mechanical loading can compromise their structural integrity and disrupt drug release.

Efficacy, Safety and Immunogenicity of Sun's Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study.

Introduction: The study aimed to evaluate comparability in terms of efficacy, safety and immunogenicity of Sun's ranibizumab biosimilar with reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).

Methods: This prospective, randomised, double-blind, two-group, parallel-arm, multicentre, phase 3 comparative study included patients with nAMD ≥ 50 years, randomised (in a 2:1 ratio) in a double-blind manner to receive 0.5 mg (0.

G-quadruplexes in MTOR and induction of autophagy.

G-quadruplex (G4) structures have emerged as singular therapeutic targets for cancer and neurodegeneration. Autophagy, a crucial homeostatic mechanism of the cell, is often dysregulated in neurodegenerative diseases and cancers. We used QGRS mapper to identify 470 G4 sequences in MTOR, a key negative regulator of autophagy.

Novel Machine Learning-Based Method for Estimation of the Surface Area of Porous Silica Particles.

This work reports a novel and quick method to estimate the surface area of porous materials. Conventionally, surface area measurement requires the BET method/N adsorption experiment which is time-consuming. In this work, we developed a method based on machine learning (ML) and the adsorption of a conductive dye on porous materials.

The small G-protein Rac1 in the dorsomedial striatum promotes alcohol-dependent structural plasticity and goal-directed learning in mice.

Unlabelled: The small G-protein Rac1 promotes the formation of filamentous actin (F-Actin). Actin is a major component of dendritic spines, and we previously found that alcohol alters actin composition and dendritic spine structure in the nucleus accumbens (NAc) and the dorsomedial striatum (DMS). To examine if Rac1 contributes to these alcohol-mediated adaptations, we measured the level of GTP-bound active Rac1 in the striatum of mice following 7 weeks of intermittent access to 20% alcohol.

Entanglement Swapping and Swapped Entanglement.

Entanglement swapping is gaining widespread attention due to its application in entanglement distribution among different parts of quantum appliances. We investigate the entanglement swapping for pure and noisy systems, and argue different entanglement quantifiers for quantum states. We explore the relationship between the entanglement of initial states and the average entanglement of final states in terms of concurrence and negativity.

Optimizing human α-galactosidase for treatment of Fabry disease.

Fabry disease is caused by a deficiency of α-galactosidase A (GLA) leading to the lysosomal accumulation of globotriaosylceramide (Gb3) and other glycosphingolipids. Fabry patients experience significant damage to the heart, kidney, and blood vessels that can be fatal. Here we apply directed evolution to generate more stable GLA variants as potential next generation treatments for Fabry disease.

A Rare Gingival Lesion in Children: Fibroepithelial Hyperplasia.

Aim And Objective: This case report aims to describe the management of a case of rare gingival lesion in a young pediatric patient.

Background: An increase in the size of the gingival tissue is known as gingival hyperplasia. This can cause esthetic as well as functional problems, and interfere with normal functions like mastication and speech.

Penile Fracture at the Crus of the Penis - A Rare Case Report.

Penile fracture is an uncommon acute surgical emergency, typically occurring after sexual intercourse, self-manipulation and at times, may be accidental. We report here a 39-year male who attended the department of emergency with swelling and bruising of the scrotum and penis. Physical examination exhibited a diffuse abdominal and perineal ecchymosis.

Chimeric nanoparticles for targeting mitochondria in cancer cells.

Mitochondrial dysfunction is implicated in myriad diseases, including cancer. Subsequently, targeting mitochondrial DNA (mt-DNA) in cancer cells has emerged as an unorthodox strategy for anti-cancer therapy. However, approaches targeting only one component of the mitochondrial "central dogma" can be evaded by cancer cells through various mechanisms.

Human radiolabeled mass balance studies supporting the FDA approval of new drugs.

Human radiolabeled mass balance studies are an important component of the clinical pharmacology programs supporting the development of new investigational drugs. These studies allow for understanding of the absorption, distribution, metabolism, and excretion of the parent drug and metabolite(s) in the human body. Understanding the drug's disposition as well as metabolite profiling and abundance via mass balance studies can help inform the overall drug development program.

Nanoparticle-Mediated Routing of Antibiotics into Mitochondria in Cancer Cells.

In recent years, antibiotics have emerged as alternative medicines in cancer therapy due to their capability of mitochondrial dysfunction in cancer cells. However, antibiotics render collateral damage in noncancerous cells by targeting mitochondrial transcription and translational machinery. To address this, herein, we have engineered three different mitochondria-targeted cationic antibiotic (tigecycline)-loaded nanoparticles from cholesterol conjugates.

Interprofessional clinical training based in a federally qualified health center: a short report.

A.T. Still University and HealthPoint, a federally qualified health center, worked together to develop novel interprofessional educational clinical experiences for dental and medical students.

Basal Forebrain Parvalbumin Neurons Mediate Arousals from Sleep Induced by Hypercarbia or Auditory Stimuli.

The ability to rapidly arouse from sleep is important for survival. However, increased arousals in patients with sleep apnea and other disorders prevent restful sleep and contribute to cognitive, metabolic, and physiologic dysfunction [1, 2]. Little is currently known about which neural systems mediate these brief arousals, hindering the development of treatments that restore normal sleep.

Testicular cancer: improving outcomes with national quality performance indicators.

Testicular cancer is the most common malignancy in young adult men. The prognosis is excellent in limited disease and cure is possible even in advanced disease. Quality performance indicators (QPI) are used in many developed countries as a measure of healthcare performance.