Chemistry for Toxicological Risk Assessment —Transitions in Expected Approach

One of the cornerstones of biocompatibility evaluations is the use of toxicological risk assessment to screen for potential hazards and safeguard against long-onset risks like cancer. While there is an abundance of toxicological literature available, and the techniques of toxicological risk assessment are generally accepted, the process for conducting the underlying chemistry studies is less mature. FDA has been building finesse in reviewing chemistry studies, helping the testing facilities to be more aware of the nuances in chemistry. New internal awareness and recent reports with poorly conducted studies used for regulatory submissions have raised anxiety regarding the extent of use of chemistry for toxicology (“ChemTox”) within the agency over the last year and motivated changes in expectations. A key change in ChemTox is the amount and type of information expected for submission. Regulators are asking for details regarding the methods used in identification of compounds and providing suggestions on when a compound should be considered an unknown. Part of this scrutiny is arising due to recent publications that focus on the shortcomings of external databases and automatic compound matching algorithms. Another focus is on detailed information regarding the type and quality of concentration quantification. FDA has been asking for details regarding the number and type of internal standards used and how this extrapola...
Source: MDDI - Category: Medical Devices Authors: Tags: Testing Source Type: news

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  Cannabis, weed, marijuana, pot. It goes by several names, but we all know what it smells like. As weed becomes more mainstream, we on the Not Crazy podcast want to know: Is marijuana really an effective treatment for anxiety? Is it just a coping mechanism? Or a vice? In today’s podcast, Gabe and Jackie look at the research and weigh out the evidence. They also interview Eileen Davidson, a rheumatoid arthritis patient who regularly uses marijuana as a medicine to see what she has to say. What’s your take? Tune in for an open-minded discussion about weed. (Transcript Available Below) SUBSCRIBE &REV...
Source: World of Psychology - Category: Psychiatry & Psychology Authors: Tags: Anxiety and Panic General Medications Not Crazy Podcast Source Type: blogs
Discussion Tachycardia is a rapid heart rate that is above normal for age and level of exertion. Tachycardia is common, particularly sinus tachycardia due to normally encountered circumstances such as pain, fever or exercise. It is usually a normal physiologic process but sustained tachycardia often indicates a potentially abnormal underlying cause. Sinus tachycardia has a rapid heart rate with normal P waves and P-R intervals and variations from moment to moment and respiration. Generally it is not over 200 beats/minute. Vagal stimulation can slow the heart rate; this is a gradual slowing, not an abrupt slowing seen in ...
Source: PediatricEducation.org - Category: Pediatrics Authors: Tags: Uncategorized Source Type: news
The future of healthcare is shaping up in front of our very eyes with advances in digital technologies, such as artificial intelligence, VR/AR, 3D-printing, robotics or nanotechnology. We have to familiarize with the latest developments in order to be able to control technology and not the other way around. The future of healthcare lies in working hand-in-hand with technology and healthcare workers have to embrace emerging technologies in order to stay relevant in the coming years. Be bold, curious and informed! Are you afraid that robots will take over the jobs of nurses, doctors and other healthcare professionals? Are y...
Source: The Medical Futurist - Category: Information Technology Authors: Tags: Future of Medicine 3d printing AI artificial intelligence augmented reality genetics Health Healthcare nanotechnology Personalized medicine pharma pharmacology robotics virtual reality wearables GC1 Source Type: blogs
ConclusionsThere is an association between the capacity to forgive and the experience of chronic pain. Further research should examine forgiveness as an intervention in a population of chronic pain patients to explore this relationship further.
Source: Irish Journal of Medical Science - Category: General Medicine Source Type: research
CONCLUSION: pain in palliative patients is mainly experienced by cancer patients and the elderly. Psychological factors affect the condition of pain, so the management that includes biopsychosocial aspect will be able to reduce pain significantly. PMID: 32041912 [PubMed - in process]
Source: Acta medica Indonesiana - Category: Internal Medicine Tags: Acta Med Indones Source Type: research
Conclusion Learning how to pay attention to our attention (meta-attention) can be transformative. Using principles from cognitive science, we can create a comprehensive approach (attention capital theory in medicine) to reclaim the meaning and joy that has been depleted from our profession. Increasing the difficulty of our work to match our skill level, delegating low-level tasks to help us focus on critical steps in our physician zone, creating rules to eliminate distractions, and noticing both the wonder and suffering around us may be more important than resilience training or wellness modules. Although well-intention...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Medical Practice Physicians Burnout physician burnout physician wellness Sanj Katyal Source Type: blogs
In conclusion, this study suggests that epigenetic age acceleration is significantly associated with lung function in women older than 50 years. We hypothesised that this could be due to menopause. However, we have observed that menopause has minimal effect and therefore there is possibility of other unknown physiological factors at older age in females mediating the epigenetic age acceleration effect on lung function. While, it is still unknown what exactly epigenetic aging from DNA methylation measures, this study suggests it can be utilised as one of the important factors to assess women's lung health in old age. DNA me...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Advanced cancer patients are at an increased risk of developing depressive symptoms, which can lead to major depressive disorder and a poor quality of life. It is important that symptoms of depression to be addressed early and frequently throughout the trajectory of the disease process. Depression is underdiagnosed and therefore undertreated in advanced cancer patients. Clinicians often fail to perform regular depression screenings as recommended by the National Comprehensive Cancer Network. Depressive symptoms are overlooked as they tend to overlap with the effects of disease progression and cancer treatments. Patients' c...
Source: Journal of Hospice and Palliative Nursing - Category: Nursing Tags: Symptom Management Series Source Type: research
By DOUGLAS BRUCE, PhD On January 1, 2020, recreational cannabis use became legal in Illinois. More than 80,000 people in Illinois are registered in the state’s medical cannabis program. Surprisingly, many of their doctors don’t know how to talk with them about their medical cannabis use.  As a health sciences researcher, I have a recommendation that is both practical and profound: Physicians can learn first-hand from their own patients how and why they use medical cannabis, and the legalization of recreational cannabis may make them more comfortable discussing its usage overall. Nationwide, p...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Medical Practice Physicians Cannabis Douglas Bruce marijuana legalization medical cannabis Medical Marijuana Source Type: blogs
CONCLUSIONS: MT may lead to immediate decreases in pain and worry in children with cancer who are receiving palliative care, however the effects may not be sustained long term. Difficulties regarding protocol feasibility including recruitment and study compliance remain important considerations for future work. PMID: 31987232 [PubMed - in process]
Source: Complementary Therapies in Medicine - Category: Complementary Medicine Authors: Tags: Complement Ther Med Source Type: research
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