Clinical Safety Articles & Analysis
17 articles found
This application is fundamental in the development of ophthalmic drugs and ensuring their safety for clinical use. Disease Modeling: The cell line aids in studying pathological conditions such as dry eye syndrome, corneal dystrophies, and infections. ...
The main risk associated with HCP is immunogenicity and they have the potential to affect the safety and efficacy of a given drug product. HCP is a complex mixture with a variety of physicochemical and immunological properties. Almost all HCPs are foreign proteins with clinical safety risks due to their potential to trigger an immune response in ...
There are no known biological risks associated with exposure to magnetic fields of the strength used in clinical MRI’s. And though there have been compatibility issues with medical devices, such as pacemakers, the clinical safety of an MRI scan has always been quite high, and newer devices are even improving it. ...
The opioid crisis in the United States is a devastating public health issue, with over 70,000 overdose deaths annually, largely driven by the highly potent synthetic opioid fentanyl. The urgency to address this crisis has spurred the development of innovative therapies to prevent and reverse fentanyl overdoses. In this blog, we will explore the groundbreaking preclinical work on CSX-1004, a fully ...
Application of flow cytometry in drug development and research FC has a wide range of applications and participates in all aspects of the entire drug development process, including drug development and target confirmation, non-clinical safety and toxicity evaluation, and clinical research. 1. ...
With the rising demand for improving patient safety in clinical trials, the adoption of patient-centric solutions is considered the best route to enhance data accuracy and experience automated workflows. ...
ByClinion
Study Overview: Design: Prospective, randomized, open-label, multi-center, international, clinical safety and efficacy investigation. Randomization: Treatment with AccuCinch System plus guideline-directed medical therapy (GDMT) or GDMT alone. ...
By engaging CD16-positive NK cells, AFM13 leads to NK cell-mediated killing of tumor cells.1 Pembrolizumab (Keytruda®) is approved in patients with R/R classical Hodgkin lymphoma as monotherapy. AFM13 showed single agent clinical activity with solid safety profile in a Phase 1 study2. Pre-clinical in vivo data of the combination of AFM13 with ...
Drug development process needs extensive collaborations with internal & external stakeholders, co-ordination with cross functional teams like R&D, QA, clinical research, safety, manufacturing, supply chain, marketing, and so on. At every phase of development process, companies are responsible for the safety and efficacy of their drug for ...
ByDDi LLC
In turn, these patients experience the very tangible benefits of time savings, financial savings, improved clinical outcomes, and enhanced safety. For example, new mothers are often unable or unwilling to be away from their newborn for an entire day as a result of being under anesthesia. ...
Introducing Beacon Biosignals: a neurotechnology company founded to develop machine learning-enabled EEG neurobiomarkers and accelerate precision medicine for any disease state affecting the brain Founded by MD/PhDs and engineers from Harvard and MIT, Beacon is propelled by the vision of a computing platform designed to scale the interrogation of large brain datasets with unprecedented ...
The risk domains include operational, human capital, technology, hazard, strategic, clinical/patient safety, legal/regulatory and financial risks. From there, you will need to determine areas of focus that need improvement, which will necessitate access to data that can adequately highlight trouble spots or potential success stories—like declines in ...
For women who want to have children when the time is right, egg freezing is a viable option and one that has become more popular in recent years. As an abundance of fertility clinics pop up nationwide, it is important to consider the safety implications of IVF, egg freezing, and fertility clinics. ...
Phased Implementation Phase I, which was effective on Jan. 1, 2014, required hospitals to establish alarm safety as an organizational priority by July 1, 2014, and to identify during 2014 the most important alarms to manage based on their own internal situations. Phase II, which begins Jan. 1, 2016, hospitals are expected to establish and implement specific components of policies and procedures ...
The topics will cover its pharmacological effects, its actions in clinical practice regarding both efficiency and safety, as well as pharmacoeconomic studies. A particular emphasis will be put on trials conducted in children, in adults suffering from chronic obstructive pulmonary diseases (COPD) and in special patient populations.Keywords: immunostimulation, ...
Clinical efficacy, tolerability and safety of various doses of Iodine-Lithium-α-Dextrin (ILαD) monotherapy have been evaluated in 56 HIV-infected patients enrolled in double blind uncontrolled randomised study during 48 weeks follow-up period. ...
This purified vaccine was tested in the clinical phase I/II trial in healthy non-infected adults in China. About 518 volunteers in Southern region and 650 volunteers from the Northern region of China were vaccinated. ...