Archive for the ‘Pharma and Medical Device Safety’ Category

๐€๐ซ๐ž ๐œ๐ก๐ข๐œ๐ค๐ž๐ง ๐ž๐ ๐ ๐ฌ ๐ญ๐ก๐ž ๐ฅ๐ž๐š๐๐ข๐ง๐  ๐ฌ๐จ๐ฎ๐ซ๐œ๐ž ๐จ๐Ÿ ๐š๐ซ๐š๐œ๐ก๐ข๐๐จ๐ง๐ข๐œ ๐š๐œ๐ข๐ ๐ข๐ง ๐ญ๐ก๐ž ๐€๐ฆ๐ž๐ซ๐ข๐œ๐š๐ง ๐๐ข๐ž๐ญ? ๐‡๐จ๐ฐ ๐ข๐ฌ ๐š๐ซ๐š๐œ๐ก๐ข๐๐จ๐ง๐ข๐œ ๐š๐œ๐ข๐ ๐ฅ๐ข๐ง๐ค๐ž๐ ๐ญ๐จ ๐ข๐ง๐Ÿ๐ฅ๐š๐ฆ๐ฆ๐š๐ญ๐ข๐จ๐ง ๐š๐ง๐ ๐ญ๐ก๐ž ๐š๐ ๐ข๐ง๐  ๐š๐ง๐ ๐ฉ๐ซ๐ž๐ฆ๐š๐ญ๐ฎ๐ซ๐ž ๐š๐ ๐ข๐ง๐  ๐จ๐Ÿ ๐ญ๐ก๐ž ๐›๐จ๐๐ฒ?

Yes, chicken and eggs are major sources of arachidonic acid in the American diet, with chicken often cited as the top source and eggs as a very significant one.ย Excess arachidonic acid is linked to inflammation through the production of inflammatoryย eicosanoids, which can contribute to chronic diseases and may be associated with premature aging. The body […]

BLA: Transforming Data into Regulatory Success

๐‚๐Œ๐‚ ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ ๐’๐ญ๐ซ๐š๐ญ๐ž๐ ๐ฒ ๐ข๐ง ๐š ๐ง๐ฎ๐ญ๐ฌ๐ก๐ž๐ฅ๐ฅ: ๐ˆ๐ญ’๐ฌ ๐ญ๐ก๐ž ๐š๐ซ๐ญ ๐จ๐Ÿ ๐ญ๐ฎ๐ซ๐ง๐ข๐ง๐  ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ ๐ฆ๐š๐ง๐ฎ๐Ÿ๐š๐œ๐ญ๐ฎ๐ซ๐ข๐ง๐  ๐๐š๐ญ๐š ๐ข๐ง๐ญ๐จ ๐š ๐ฌ๐ญ๐จ๐ซ๐ฒ ๐จ๐Ÿ ๐œ๐จ๐ง๐ญ๐ซ๐จ๐ฅ ๐š๐ง๐ ๐œ๐จ๐ง๐ฌ๐ข๐ฌ๐ญ๐ž๐ง๐œ๐ฒ ๐ญ๐ก๐š๐ญ ๐ซ๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฌ ๐œ๐š๐ง ๐ญ๐ซ๐ฎ๐ฌ๐ญ. ๐…๐จ๐ซ ๐š ๐๐ก๐š๐ฌ๐ž ๐Ÿ‘ ๐›๐ข๐จ๐ฅ๐จ๐ ๐ข๐œ, ๐ญ๐ก๐ข๐ฌ ๐ฆ๐ž๐š๐ง๐ฌ: โœ… ๐…๐ซ๐จ๐ฆ ๐ƒ๐ž๐ฏ๐ž๐ฅ๐จ๐ฉ๐ฆ๐ž๐ง๐ญ ๐ญ๐จ ๐‚๐จ๐ฆ๐ฆ๐ž๐ซ๐œ๐ข๐š๐ฅ: ๐‰๐ฎ๐ฌ๐ญ๐ข๐Ÿ๐ฒ๐ข๐ง๐  ๐ญ๐ก๐ž ๐ฌ๐ก๐ข๐Ÿ๐ญ ๐ญ๐จ ๐š ๐ฏ๐š๐ฅ๐ข๐๐š๐ญ๐ž๐, ๐ฌ๐œ๐š๐ฅ๐š๐›๐ฅ๐ž ๐ฉ๐ซ๐จ๐œ๐ž๐ฌ๐ฌ ๐ฐ๐ข๐ญ๐ก ๐š ๐ฌ๐œ๐ข๐ž๐ง๐œ๐ž-๐›๐š๐œ๐ค๐ž๐ ๐œ๐จ๐ฆ๐ฉ๐š๐ซ๐š๐›๐ข๐ฅ๐ข๐ญ๐ฒ ๐ฉ๐ฅ๐š๐ง. โœ… ๐๐ฎ๐ข๐ฅ๐๐ข๐ง๐  ๐ญ๐ก๐ž ๐‚๐จ๐ง๐ญ๐ซ๐จ๐ฅ ๐๐š๐ซ๐ซ๐š๐ญ๐ข๐ฏ๐ž: […]

Options After Stage 4 Glioblastoma Diagnosis and Resection Surgery

I’m deeply sorry to hear about your father’s diagnosis. Glioblastoma (GBM), especially grade 4, is an aggressive brain cancer, but there are treatment options and emerging therapies that may offer hope. Below is a structured overview ofย standard treatments,ย promising clinical trials, andย cutting-edge therapiesย you can explore while awaiting the histology report. 1. Standard of Care (Post-Surgery) Once […]

Comparing Google AI and DeepSeek AI: how does a cleaning service develop its first “quality management system” ?

From Google AI: To develop a first quality management system (QMS) as a cleaning service, you should start byย clearly defining your quality standards, establishing customer-focused expectations, documenting cleaning procedures, training staff thoroughly on these standards, implementing regular quality checks through inspections and client feedback, and continuously monitor and improve processes based on feedback to maintain […]

Reflections on AGING

As our bodyโ€™s building blocks break down, our organs and tissues experience an associated loss ofย structure and function. This results in a cycle of inflammation and tissue fibrosis that reduces the functional capacity of our vital organs. While tremendous recent progress has been made in the field of aging, the emphasis has begun to shift from extending lifespan (the number of years one is alive) to maximizing an individualโ€™s healthspan (the number of years one is active and without disease).

Patient Compliance, Investigator Compliance, and More Compliance

Importance of Compliance: Compliance (adherence to the study protocol by participants and researchers) is a cornerstone of successful clinical trials. Poor compliance can lead to unreliable results, increased costs, and even trial failure. Types of Compliance: Participant Compliance: Refers to how well participants follow the trial protocol, including taking medications as prescribed, attending scheduled visits, […]

COVID-19 Treatment Strategies: September 2024 update

Moving Simulation of SARS-CoV-2 Delta Variant

Image:ย  Computerย Simulation of SARS-CoV-2. Reprinted with kind permission of Janet Iwasa of http://animationlab.utah.edu/cova Update September 2024 COVID-19 Treatment Strategies As of 2023, a few small-molecule antiviral drugs (nirmatrelvir-ritonavir, remdesivir, and molnupiravir) and 11 monoclonal antibodies have been marketed for the treatment of COVID-19, mostly requiring administration within 10 days of symptom onset. Hospitalized patients with […]

Combining Research, Safety, and Epidemiology

Risk Management Consulting (RMC), a health services research firm, offers Research, Safety, and Epidemiology services with experience in the healthcare consulting and biopharmaceutical industries. RMC provides the health care system, biopharmaceutical industry, academia, and the Federal Government with “real-world” data to improve the quality, safety, and affordability of healthcare. RMC’s projects range from retrospective to […]