Safety Data Articles & Analysis
24 articles found
In Vitro and In Vivo Studies: Prior to human trials, extensive laboratory studies are conducted to evaluate the efficacy, stability, and safety of the conjugate. This includes assessing how well the conjugate binds to its target and how effectively it can deliver radiation to kill cancer cells. 4. ...
Fundamentally, TK studies provide an understanding of the systemic exposure-risk relation and delivery of safety data for the dose-response analysis. It outlines parameters such as the maximum tolerated dose, no observable adverse effect level, or the lethal dose for a certain percent of the population. ...
Pharmacokinetics and Pharmacodynamics (PK/PD) AnalysisStudying the absorption, distribution, metabolism, and excretion characteristics of ADC in the body, as well as the relationship between drug concentration and efficacy, is the basis for understanding its efficacy and safety framework. These data are crucial for designing appropriate administration plans and ...
Available from: https://nj.gov/health/eoh/rtkweb/documents/fs/1578.pdf 4. Safety data sheet potassium permanganate [Internet]. AquaPhoenix Scientific. 2015. ...
In recent years, there has been a growing trend of using video technology in surgical procedures to enhance precision, communication, and training. While the benefits of video in surgery are many, there are also concerns regarding the legal risks that may arise from its use. Medical professionals fear that video footage of a surgery could potentially be used against them in legal proceedings, ...
Mental health is a critical concern for all companies. One in five individuals will experience a mental health problem during their lives, according to the World Health Organization. For many people, the workplace is where mental health problems first begin and/or become exacerbated. ...
Why Do You Need One? A medical battery pack is an essential part of any medical device. It provides power to the device when no other power source is available. This kinf of battery pack can be used on a number of devices, including portable defibrillators, heart monitors and other life-saving devices. There are many different types of medical battery pack manufacturing on the market today. ...
ADC Pharmacokinetic Model The application of models can integrate PK, efficacy, and safety data to meet the needs of ADC drug development at different stages, such as target selection, antibody affinity, linker stability, animal-to-human extrapolation, dose selection and adjustment, exposure-response relationships, DDI studies, etc. ...
DSTP3086S, a humanized IgG1 anti-steap1 monoclonal antibody related to MMAE, demonstrated safety and significant antitumor activity in a Phase I trial of 77 mCRPC patients. ...
As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms. In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when ...
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 PD1-blockade showed synergism and the potential for induction of cross-talk between innate and adaptive immunity.3 Based on these findings, we conducted a Phase 1b study evaluating the safety and ...
Revisiting the “why” behind decision making can be a helpful exercise in all aspects of business. This is no less true for clinical operations executives when it comes to the clinical trial systems they employ to facilitate their teams’ work. The technology that supports clinical trial systems has evolved steadily over the past several decades, yet the ultimate goal of ...
Place bo-control led trials assessing microbiome therapeutics have demonstrated efficacy in recurrent CDI; hov/ever, long-term safety and efficacy data from rigorously conducted studies of microbiome therapies, including cumulative efficacy in those who received a second dose following a CDI recurrence, is limited. ...
This is not only a frustrating experience for patients, but it can also compromise the safety data in a clinical trial. The good news is that we may be able to solve this problem with open-source artificial intelligence (AI) and old-fashioned scientific validation. ...
ByAiCure
While some clinical research has found positive correlations between probiotic supplementation and a reduction in thrush, BV, UTIs, vaginal dryness, or other genital tract issues — larger scale studies, efficacy and safety data are needed to propel the vaginal probiotics space ...
ByJuno Bio
The NIH ceased randomly assigned treatments in 2015, when data was presented to the Data and Safety Monitoring Board showing treatment to SBP of less than 120 decreased the rate of a composite cardiovascular disease (CVD) outcome by 25 percent and the rate of all-cause death by 27 percent. Researchers reported these findings in 2015, but ...
Food and Drug Administration for children under emergency use authorization, with others expected to follow soon, many are seeking information on the safety, efficacy, and necessity of COVID-19 vaccines for children, as parents face the critical decision of if and when to vaccinate. This blog answers the most common questions with an in-depth look at the available ...
ENB Therapeutics reports preliminary data from the ongoing Phase 1/2 trial assessing the safety and efficacy of lead product ENB-003 in combination with pembrolizumab. Safety data are encouraging with no significant drug related safety events from the first 3 dosing cohorts. ...
“Early safety and efficacy data on the transcatheter Accucinch system is impressive and suggests the therapy has the potential to repair the left ventricle, improve heart function, and restore the quality of life for heart failure patients,” said Satya Shreenivas, interventional cardiologist at The Christ Hospital Heart and Vascular Center and The ...
The data was presented at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. ...