Biocon Biologics’ Post

Pharmaceutical Drug Supply Chain Security Act (FDA DSCSA) becomes mandatory November 2024. DSCSA is no less than a tectonic shift for all pharmaceutical drugs industry stakeholders including drug manufacturer, repacker, wholesaler, third (3rd) party service providers and the last-mile drug dispensers pharmacies and hospitals. Identifiers on product and case levels, track & trace, interoperable transaction sharing and transaction history requirements with DSCSA, etc. can be daunting LEGAL requirements to meet for regulatory drug security compliance! Finding relevant FDA legal regulatory intelligence when DSCSA regulations vary from one stakeholder role to another was complex and challenging not to mention super time consuming. The https://ow.ly/CQ2Q50QMCNS database search site remains abysmal with its metadata (tags assigned) based search algorithm to respond to your query. eSTARHelper has recently hosted its FDA DSCSA Copilot steered toward FDA sites and provisioned all DSCSA Guidance PDF and supply chain related 21 CFRs from https://ow.ly/CQ2Q50QMCNS available FREE, No Credit Card gimmicks on this fully functioning preview website, no account logins nor app store downloads needed, just point your browser and jam with the DSCSA Chatbot! This unique ChatGPT-4 based bot accepts natural language query and even provides the underlying source citations for your AI/ML bias fact checking. It goes one step further by integrating our Free, No Credit card SmartSearch+, i.e. a full-text search option with You-the-Human searching against ACTUAL FDA contents in order to fact-check AI/ML inherent training bias for verifiable accuracy. SmartSearch+ works like Google without the web noise or clutter. FDA DSCSA Copilot is now available for preview here https://ow.ly/ocHK50QMCNR …..no login account signups needed, no app store downloads and it’s Free, no Credit card gimmicks, just point your browser from your mobile phone, tablets or laptops! It’s like having a US FDA regulations pharma drugs, devices or biologics expert in your pocket! TRY IT NOW! Want to build one just like it BUT customized with your chatbot OWN prompts/replies and preloaded with your enterprise data? ( like SOPs (Standard Operating Procedures), company policy or manuals, reports etc) while leveraging CharGPT-4 AI/ML Chatbot? Send us an email with your questions or interests here – rbalani@estarhelper.com

Pharmaceutical Drug Supply Chain Security Act (FDA DSCSA) becomes mandatory November 2024. DSCSA is no less than a tectonic shift for all pharmaceutical drugs industry stakeholders including drug manufacturer, repacker, wholesaler, third (3rd) party service providers and the last-mile drug dispensers pharmacies and hospitals. Identifiers on product and case levels, track & trace, interoperable transaction sharing and transaction history requirements with DSCSA, etc. can be daunting LEGAL requirements to meet for regulatory drug security compliance! Finding relevant FDA legal regulatory intelligence when DSCSA regulations vary from one stakeholder role to another was complex and challenging not to mention super time consuming. The https://ow.ly/CBXP50QMCNT database search site remains abysmal with its metadata (tags assigned) based search algorithm to respond to your query. eSTARHelper has recently hosted its FDA DSCSA Copilot steered toward FDA sites and provisioned all DSCSA Guidance PDF and supply chain related 21 CFRs from https://ow.ly/CBXP50QMCNT available FREE, No Credit Card gimmicks on this fully functioning preview website, no account logins nor app store downloads needed, just point your browser and jam with the DSCSA Chatbot! This unique ChatGPT-4 based bot accepts natural language query and even provides the underlying source citations for your AI/ML bias fact checking. It goes one step further by integrating our Free, No Credit card SmartSearch+, i.e. a full-text search option with You-the-Human searching against ACTUAL FDA contents in order to fact-check AI/ML inherent training bias for verifiable accuracy. SmartSearch+ works like Google without the web noise or clutter. FDA DSCSA Copilot is now available for preview here https://ow.ly/pE8250QMCNW …..no login account signups needed, no app store downloads and it’s Free, no Credit card gimmicks, just point your browser from your mobile phone, tablets or laptops! It’s like having a US FDA regulations pharma drugs, devices or biologics expert in your pocket! TRY IT NOW! Want to build one just like it BUT customized with your chatbot OWN prompts/replies and preloaded with your enterprise data? ( like SOPs (Standard Operating Procedures), company policy or manuals, reports etc) while leveraging CharGPT-4 AI/ML Chatbot? Send us an email with your questions or interests here – rbalani@estarhelper.com

Some EXCEL Fun? Why not 🙈 In times when I feel low because of boredom, this is what I end up doing! Some excel fun. Via various data visualisation functions like sparklines, bar charts, line charts, area and scatter charts with some dynamic elements too (via “data validation tool” (click “Data” in Google Sheets and you will find it there) Practicing with random datasets from the net can actually help anybody with their visualisaion skills. Be it for the company you are working or for your own startup, you can review a lot of your progress and drive insights that will help take critical decisions, something which is only possible if : i) we have the information, ii) we know how to transform it, iii) And lastly we know how to utilise the visualisation tools. So what are you waiting for? Open your mircosoft excel and watch youtube videos that can actually guide you and help you gain your skills which will make you vital for the company 😊 Also, the link to my dashboard (please open 2nd page bottom part) : https://lnkd.in/gTecG9e4

What's latest in the #510k #regulatorysubmission process for #MachineLearning products? Join our Subject Matter Expert Edwin Waldbusser to ensure you are doing everything right to get your futuristic product approved. https://lnkd.in/g-R8vkdg #Pharmaceuticals #Medicaldevices #webinars #seminars #fda #regulatorycompliance #compliancetrainings

Finding the Alternative Path- Formulation strategies for sustained release of challenging small molecule compounds Le An Elizabeth Levy "The iPRECIO pump IV infusion and SC strategies can alter the PK profile resulting in a longer acting sustained release compared to PO and IP." American Association of Pharmaceutical Scientists (AAPS) | @aapscomms ePoster Library; Oct 24 2023; 403266 https://lnkd.in/gePDEi6i #drugdiscovery #drugdelivery #invivo #phamaceutics #smallmolecules #formulations iPRECIO Programmable Minipumps for better Predictivity

Transform your data into actionable insights with powerful reporting and analysis tools. Visualize your study's progress and make informed decisions to stay ahead of the curve with automated report distribution. Discover all OpenClinica has to offer in a free demo: https://bit.ly/3KbcaTT #OpenClinica #ClinicalTrials

The compiled list of important formulae in the Pharmacokinetics to calculate plasma clearance, volume of distribution, oral bioavailability, oral exposure, half-life, and mean residence time. It also includes the glossary of terms used in Pharmacokinetics. #pharmacokinetics #pharmaceuticals #pharmaceuticalindustry #pharmaindustry #pharmacystudents #research #pharmacy #pharmacology

🔬 Spotlight on Innovation: NovoMedix, LLC! 🌟 Company Overview: NovoMedix, LLC is a visionary organization steering advancements in pharmaceutical compositions. With a laser focus on addressing diseases attributed to abnormal blood glucose levels, they are leading the charge in developing solutions for treating and preventing such diseases. Moreover, NovoMedix, LLC is breaking new ground in formulating methods to alleviate symptoms of cardiovascular diseases. 🧪 Patent Highlight: Their recent patent (🔗 Patent ID: 10988442) unveils the development of nitrite salts of 1,1-dimethylbiguanide and their isotopic variants. These compounds are not just innovative but are potential game-changers, paving the way for creating pharmaceutically acceptable hydrates and solvates. The application of these compounds in pharmaceutical compositions is a testament to NovoMedix’s commitment to innovation and development in the medical field. 🔍 Discover More with Molecule-Search.com: Curious about the intricate details of NovoMedix’s research focus areas? Dive deeper with molecule-search.com! Leveraging advanced LLMs like OpenAI GPT-4, we provide concise and accurate summaries of a company’s research focus drawn from their patents. It's your go-to platform to uncover the innovations and breakthroughs companies like NovoMedix, LLC are contributing to the pharmaceutical industry. 🌐 Stay Informed & Stay Ahead! Join us in exploring the frontiers of pharmaceutical research and development. Discover, learn, and stay informed about the latest innovations with molecule-search.com! #PharmaceuticalInnovation #NovoMedix #ResearchAndDevelopment #OpenAIGPT4 #MoleculeSearch

Focus of Innovation of Vitalis Executive Summary Based on the patent details of Vitalis LLC, the main focus area of the organization appears to be the development of compositions and methods for treating multiple sclerosis (MS). The organization has recently patented a composition and method involving the oral administration of aspirin and fumaric acid or its derivatives for the treatment of MS. Main Focus Areas: - Vitalis LLC focuses on developing treatments for multiple sclerosis. - The organization has patented compositions and methods specifically designed for the treatment of MS. - The patented method involves orally administering a specific combination of aspirin and fumaric acid or its derivatives. - The dosage range for the administration of aspirin is approximately 80 mg to 500 mg per day. - The dosage for the administration of fumaric acid or its derivatives is approximately 360 mg per day. - Vitalis LLC aims to provide effective treatment options for MS patients. Learn more at https://lnkd.in/eQNzMi7d #patent #pharma #landscaping #vitalisllc

⭐ Digitalizing the TIM-1 gastrointestinal model ⭐ 🔬 For nearly three decades, the TIM-1 gastrointestinal model has been at the forefront of biorelevant dissolution testing, closely simulating the human gastrointestinal tract. Within the pharmaceutical sector, TIM-1 system plays an important role in aiding drug product design and offering a biopredictive evaluation of drug product performance. 💊 🚀 We recently found this exciting paper, titled "Digitalizing the TIM‑1 Model using Computational Approaches−Part One: TIM‑1 Data Explorer" by Inese Sarcevica, Bart Hens, Irena Tomaszewska, and Mark McAllister. In this article, the authors introduce: TIM-1 Data Explorer. This tool delves into the intricacies of fluid and mass balance, enabling a comprehensive understanding of experimental data. Additionally, the tool empowers quantitative predictions of drug behaviour during TIM-1 experiments, including dissolution and precipitation. Two case studies are used for validation: one with paracetamol and another with a weakly basic compound, PF-07059013. In both cases, the TIM-1 Data Explorer showcased good accuracy. 🙌 Congratulations to the authors for the publication! 🙌 🔗 Read the full article here: https://lnkd.in/eYzDP-WH #TIM-1 #Digitalization #Pharma-Modelling #ComputationalApproaches