The Requirements of Managing Phase I Clinical Trials Risks: The British and Italian Case Studies.

Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes.

Phosphosulindac (OXT-328) prevents and reverses chemotherapy induced peripheral neuropathy in mice.

Background: Chemotherapy-induced peripheral neuropathy (CIPN), a side effect of chemotherapy, is particularly difficult to treat. We explored whether phosphosulindac (PS), a modified NSAID, could treat CIPN.

Methods: CIPN was induced in male C57BL/6 J mice by paclitaxel, vincristine or oxaliplatin.

Examining the Effect of Threatened Masculinity on Gun Violence.

Gun violence is considered a national epidemic in the United States. In 2020, approximately 45,000 people were killed due to firearm-related injuries in the United States alone. However, research has struggled to identify a comprehensive list of risk factors associated with gun violence.

Trends of Phase I Clinical Trials in the Latest Ten Years across Five European Countries.

Background: Phase 1 clinical trials represent a critical phase of drug development because new candidate therapeutic agents are tested for the first time on humans. Therefore, international guidelines and local laws have been released to mitigate and control possible risks for human health in agreement with the declaration of Helsinki and the international Good Clinical Practice principles. Despite numerous scientific works characterizing the registered clinical trials on ClinicalTrials.

Medication-Related Osteonecrosis of the Jaw in Cancer Patients: Result from the OneFlorida Clinical Research Consortium.

Medication-related osteonecrosis of the jaw (MRONJ) is a rare but severely debilitating drug-induced bone disorder in the jawbone region. The first MRONJ was reported in 2003 after bisphosphonate (BP) exposure. Recently, other drugs, such as receptor activator of NF-κB ligand (RANKL) inhibitor denosumab and antiangiogenic agents, were also associated with MRONJ.