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Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring.

Adverse drug reactions (ADRs) are responsible for almost 5% of hospital admissions, making it necessary to implement different pharmacovigilance strategies. The additional monitoring (AM) concept has been highlighted and intended to increase the number of suspected ADRs reported, namely in medicines with limited safety data. A prospective, descriptive study of active pharmacovigilance (AP) was conducted between 2019 and 2021 in the Local Health Unit of Matosinhos (LHUM) (Porto, Portugal). A model of AP for medicines under AM, namely oral antineoplastic agents, was designed. Follow-up consultat

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… Aspects related to the dosage, drug–drug and drug–food interactions, storage conditions, and most relevant excipients (e.g., lactose and sodium), which could potentially result in some interactions, were explained. …

Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV-INHIBITION study design.

AIMS: In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. We present the SV-INHIBITION study rationale, design, and methods. METHODS AND RESULTS: The SV-INHIBITION trial is a nationwide multicentre, randomized, double blind, placebo-controlled, Phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in

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… in another clinical trial or administration of an off‐label drug in the 4 weeks preceding the screening • Pregnancy, desire for pregnancy, absence of contraception during the study period • Severe hepatic insufficiency (Child‐Pugh C class) • Hypersensitivity to the active substance or to any of the excipients …

Analyzing the impact of subcutaneous injection needle, device, and administration characteristics on patient pain, anxiety, and safety: a systematic literature review.

The subcutaneous (SC) injection route is a commonly used and important method for therapeutic delivery of a wide range of compounds, and needle characteristics have a significant influence on patient pain, anxiety, safety, and other outcomes. This systematic review evaluates the evidence on how needle-specific characteristics (e.g. gauge, length, tip design, wall thickness, concealment) and administration- or device-related factors can affect patient-reported outcomes and clinical safety indicators during and following SC injections. A comprehensive search was conducted in MEDLINE, PubMed, Emb

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… including both needle-specific characteristics (e.g. needle length, diameter, bevel geometry, lubricity, and visibility) and broader administration-related variables such as injection site, angle, injection speed or flow rate, and biologic characteristics such as temperature, volume, viscosity, pH, and excipients … Relevant subgroup analyses by indication, device class, injection site, and biologic properties (e.g. viscosity, volume, flow rate, pH, and excipient composition) were constrained by inconsistent reporting and substantial heterogeneity across studies. …

Protocol for SARS-CoV-2 post-vaccine surveillance study in Australian adults and children with cancer: an observational study of safety and serological and immunological response to SARS-CoV-2 vaccination (SerOzNET).

BackgroundCancer is associated with excess morbidity and mortality from coronavirus disease 2019 (COVID-19) following infection by the novel pandemic coronavirus SARS-CoV-2. Vaccinations against SARS-CoV-2 have been rapidly developed and proved highly effective in reducing the incidence of severe COVID-19 in clinical trials of healthy populations. However, patients with cancer were excluded from pivotal clinical trials. Early data suggest that vaccine response is less robust in patients with immunosuppressive conditions or treatments, while toxicity and acceptability of COVID-19 vaccines in th

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… These excipients are found in many common cancer treatments and cancer patients sensitised to these agents with prior allergic reactions may be at higher risk of vaccine-related adverse effects [ 34 , 35 ]. …

Ixazomib, pomalidomide and dexamethasone in triple-class exposed multiple myeloma patients - a phase II study.

Multi-class upfront regimens for multiple myeloma (MM) have improved outcomes, yet many patients become either triple-class exposed (TCE) or refractory (TCR) early in their disease course. This is a phase II, investigator initiated, open-label, single-arm, prospective, multicenter study evaluating all-oral Ixazomib-pomalidomide- dexamethasone (IPd) regimen for TCE RRMM patients. Sixty-one patients were enrolled between March 1st 2021 and March 17th 2024. The median age was 74 (range: 53-89) years; 25 (41%) were ≥75 years old. Fiftyseven percent had high-risk cytogenetics (t(4;14), t(14;16), +1

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… Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 15. …

Обобщение и оценка воздействия нанопчастей аторвастатина и аторвастатина на вызванную ими демиелинацию Cuprizone: модуляция прохода с сигналами Nrf2/NF-kB.

Множественный склероз (MS) является хроническим воспалительным заболеванием центральной нервной системы (CNS), характеризующимся повреждением миелинской оболочки и, со временем, постепенным неврологическим расстройством. Статины привлекли внимание к исследованиям в области MS из-за их антивоспалительных и нейрозащитных эффектов. ЦЕЛИ: В этом исследовании оценивалось, может ли аторвастатин улучшить поведение и гистопатологические изменения мозга мужчины C57BL/6 Мыши. Все группы мышей, за исключением контрольной группы, которая получила нормальное питание, были накормлены 0.2% (КПЗ) в их ежеднев

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… Fourier transform infrared spectroscopy (FTIR) analysis was performed using a spectrophotometer (Shimadzu IR2000, Japan) to investigate potential interactions between atorvastatin and formulation excipients. …

Assessment of the availability of repurposed orphan drugs in India.

India has a massive burden of rare diseases (RDs), with an estimated 96 million people living with RDs but limited options for treatment. Repurposing drugs used for other common conditions are essential alternative for RDs due to their cost-effectiveness and reduced timeline. India's patent regime prevents the evergreening of drugs, and a large generic manufacturing industry provides ample opportunity to explore the potential of repurposed drugs for treating RDs, known as repurposed orphan drugs (ROD). However, there is no portal or other source for information on orphan drugs in India. This s

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… neither mentioned in Drugs@CDSCO, IP or as Nutraceuticals | Some of the drugs are available through compassionate use programs even if they do not yet have a marketing approval from one of the regulators Other sources (Special cases) https://www.usp.org/sites/default/files/usp/document/harmonization/excipients …

Medicine manipulation: An alternative to mitigate therapeutic gaps in the Brazilian Unified Health System?

Despite the various initiatives carried out in Brazil and in the world, the challenge of offering essential medicines in adequate presentations remains, especially to the public affected by diseases considered neglected and the pediatric population, for whom the therapeutic options remain limited. The main objective of this study was to evaluate the production of manipulated medicines as a strategy to mitigate therapeutic and access gaps to essential medicines within the Brazilian public health system, called the Unified Health System (SUS). The evaluation, carried out between 2020 and 2021, i

Yellow nail syndrome: a review.

Yellow nail syndrome (YNS; OMIM 153300, ORPHA662) is a very rare disorder that almost always occurs after 50 years of age but a juvenile or familial form has also been observed. YNS is diagnosed based on a triad associating yellow nail discoloration, pulmonary manifestations (chronic cough, bronchiectasia, pleural effusion) and lower limb lymphedema. Chronic sinusitis is frequently associated with the triad. YNS etiology remains unknown but a role of lymphatic impairment is usually evoked. YNS is more frequently isolated but may be associated in rare cases with autoimmune diseases, other clini

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… Other sources of titanium ions were also suggested: joint implants, surgical staples, foods (chewing gum to try to explain YNS in children), medication excipients, cosmetics (sunscreen, moisturizers, shampoo, toothpaste) [ 50 , 52 ]. …

Sotatercept in patients with osteolytic lesions of multiple myeloma.

This phase IIa study evaluated the safety and tolerability of sotatercept, and its effects on bone metabolism and haematopoiesis in newly diagnosed and relapsed multiple myeloma (MM) patients. Patients were randomized (4:1) to receive four 28-d cycles of sotatercept (0·1, 0·3, or 0·5 mg/kg) or placebo. Patients also received six cycles of combination oral melphalan, prednisolone, and thalidomide (MPT). Thirty patients were enrolled; six received placebo and 24 received sotatercept. Overall, 25% of patients received all four sotatercept doses; 71% of sotatercept-treated patients had ≥1 dose int

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… or lesions currently undiagnosed but suspect for malignancy; plasma cell leukaemia; received ESAs <21 d before study start; scheduled to receive local radiation to bone during the course of the study; history of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients …

Sophorolipids as anticancer agents: progress and challenges.

Sophorolipids (SLs) are considered effective biosurfactant for cancer treatment, which can efficiently inhibit the viability of various cancer types including breast, lung, liver, cervical and colon cancers. Their mechanism of action targets apoptosis and operates at the level of caspase enzymes, upregulation and downregulation of the B-cell lymphoma (Bcl)-family proteins, and changes in mitochondrial membrane permeability. The binding of SLs to the cancer cell receptors modulates the expression of Bax, APAF1, Bcl-2 and Bcl-x, and triggers the release of cytochrome c into the cytosol which fur

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… Further amplification of therapeutic efficacy by encapsulation with biocompatible excipients and co-delivery of synergistic drugs is currently being explored. Specific targeting of tumors can be achieved through ligand based approaches reducing systemic toxicity. …

Business Risk Mitigation in the Development Process of New Monoclonal Antibody Drug Conjugates for Cancer Treatment.

Recent developments aim to extend the cytotoxic effect and therapeutic window of mAbs by constructing antibody-drug conjugates (ADCs), in which the targeting moiety is the mAb that is linked to a highly toxic drug. According to a report from mid of last year, the global ADCs market accounted for USD 1387 million in 2016 and was worth USD 7.82 billion in 2022. It is estimated to increase in value to USD 13.15 billion by 2030. One of the critical points is the linkage of any substituent to the functional group of the mAb. Increasing the efficacy against cancer cells' highly cytotoxic molecules (

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… From a regulatory standpoint, assessment of the environmental toxicity and effects on occupational health are required for the raw materials (excipients), while drug products and medical devices follow their own framework, with a greater emphasis on the therapeutic applications [ 83 ]. …

Preclinical evaluation of the novel, orally bioavailable Selective Inhibitor of Nuclear Export (SINE) KPT-335 in spontaneous canine cancer: results of a phase I study.

BackgroundThe purpose of this study was to evaluate the activity of Selective Inhibitors of Nuclear Export (SINE) compounds that inhibit the function of the nuclear export protein Exportin 1 (XPO1/CRM1) against canine tumor cell lines and perform a Phase I clinical trial of KPT-335 in dogs with spontaneous cancer to provide a preliminary assessment of biologic activity and tolerability.Methods and findingsCanine tumor cell lines derived from non-Hodgkin lymphoma (NHL), mast cell tumor, melanoma and osteosarcoma exhibited growth inhibition and apoptosis in response to nanomolar concentrations o

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… All excipients were of suitable grades for use in pharmaceuticals. Pharmacokinetic Analysis in Healthy Dogs KPT-335 was administered as a single oral dose in capsule formulation to 6 male beagle dogs at approximately 1.5 mg/kg following a meal. …

Cyclic Peptides in Modern Drug Discovery: Trends and Therapeutic Directions.

Peptide therapeutics are an important drug modality due to their high specificity, favorable safety, and expanding design potential. Among them, cyclic peptides occupy a space between small molecules and biologics, offering improved rigidity, stability, and target engagement. This report analyzes trends in cyclic peptide research using data from the CAS Content Collection over the past two decades. Results show a steady rise in academic publications and patents, reflecting growing interest across discovery and development. Notably, oral administration is gaining attention, indicating progress

Оптимизация доставки каннабидиол: повышение растворимости и проницаемости воды посредством фосфолипидной комплексации.

Каннабидиол (КБР) продемонстрировал терапевтический потенциал в лечении эпилепсии, множественного склероза, болезни Альцгеймера, Паркинсона и Крона. Несмотря на ее многообещающие последствия и анальгетические, антивоспалительные и аксиолитические свойства, полный потенциал КБР сдерживается низкой растворимостью воды (0,7-10 мкг/мл), низкой проницаемостью и химической нестабильностью. Цель этого исследования состояла в том, чтобы повысить проницаемость кишечника (GI) в результате распада, стабильности и проницаемости кишечника КБР путем создания комплекса КБР-фосфолипид (CBD-PLC). Мы предположи

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… Fourier Transform Infrared Spectrometry (FTIR) FTIR offers a profound understanding of molecular interactions between active pharmaceutical ingredients and excipients. …

2,4 Dinitrophenol as Medicine.

In the sanctity of pure drug discovery, objective reasoning can become clouded when pursuing ideas that appear unorthodox, but are spot on physiologically. To put this into historical perspective, it was an unorthodox idea in the 1950's to suggest that warfarin, a rat poison, could be repositioned into a breakthrough drug in humans to protect against strokes as a blood thinner. Yet it was approved in 1954 as Coumadin® and has been prescribed to billions of patients as a standard of care. Similarly, no one can forget the horrific effects of thalidomide, prescribed or available without a prescri

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… Challenges for cyclosporine (ring structure with high molecular mass of 1202 g/mol) are its insolubility in water requiring detergents or lipid emulsion excipients, immunosuppression side effect, and poor penetration of the intact BBB, making it suitable only for more severe TBI where the BBB has already … DNP and prodrug have the advantage over cyclosporine of being a much smaller molecule (DNP’s molecular mass 184 g/mol), water-soluble, easily formulated as an oral and intravenous agent without the need for complex solubilization systems or toxic excipients, and easily crosses the intact BBB to reach …

The Health-Promoting Properties and Clinical Applications of Rice Bran Arabinoxylan Modified with Shiitake Mushroom Enzyme-A Narrative Review.

Rice bran arabinoxylan compound (RBAC) is derived from defatted rice bran hydrolyzed with Lentinus edodes mycelial enzyme. It has been marketed as a functional food and a nutraceutical with health-promoting properties. Some research has demonstrated this rice bran derivative to be a potent immunomodulator, which also possesses anti-inflammatory, antioxidant, and anti-angiogenic properties. To date, research on RBAC has predominantly focused on its immunomodulatory action and application as a complementary therapy for cancer. Nonetheless, the clinical applications of RBAC can extend beyond canc

Transformative Impact of Nanocarrier-Mediated Drug Delivery: Overcoming Biological Barriers and Expanding Therapeutic Horizons.

Advancing therapeutic progress is centered on developing drug delivery systems (DDS) that control therapeutic molecule release, ensuring precise targeting and optimal concentrations. Targeted DDS enhances treatment efficacy and minimizes off-target effects, but struggles with drug degradation. Over the last three decades, nanopharmaceuticals have evolved from laboratory concepts into clinical products, highlighting the profound impact of nanotechnology in medicine. Despite advancements, the effective delivery of therapeutics remains challenging because of biological barriers. Nanocarriers offe

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… Additionally, SLNs contain physiological excipients that are generally recognized as safe, such as glyceryl behenate, glyceryl monostearate, glyceryl palmitostearate, trimyristin, tripalmitin, tristearin, or wax cetyl palmitate, making them acceptable from a cosmetic standpoint and well tolerated for … Additionally, SLNs contain physiological excipients that are generally recognized as safe, such as glyceryl behenate, glyceryl monostearate, glyceryl palmitostearate, trimyristin, tripalmitin, tristearin, or wax cetyl palmitate, making them acceptable from a cosmetic standpoint and well tolerated for …

Fighting trafficking of falsified and substandard medicinal products in Russia.

BACKGROUND: The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat … ty for the production, storage and distribution of falsified medicinal products, active substances, excipients, components, materials and supplies; the use of falsified documents related to the trafficking of medicinal products (Articles 5, 6, 7). This legal act regulates the cooperation between the health authorities, customs, police and other competent aut …

Artificial intelligence in drug discovery and development.

Artificial intelligence-integrated drug discovery and development has accelerated the growth of the pharmaceutical sector, leading to a revolutionary change in the pharma industry. Here, we discuss areas of integration, tools, and techniques utilized in enforcing AI, ongoing challenges, and ways to overcome them.

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… Decision-support tools use rule-based systems to select the type, nature, and quantity of the excipients depending on the physicochemical attributes of the drug and operate through a feedback mechanism to monitor the entire process and intermittently modify it [84] . …