Jamie Weishaar

The @U.S. Food and Drug Administration released draft guidance on Phase II of its industry-wide, voluntary sodium reduction targets. If finalized, the targets would support reducing the average sodium intake to 2,750 mg per day. "In addition to our sodium reduction efforts, the FDA is also actively working on a forthcoming final rule updating the definition of the claim ‘healthy,’ a proposed rule for front-of-package nutrition labeling and exploring ways to reduce added sugars consumption," said Jim Jones, FDA's deputy commissioner for human foods. "The FDA’s sodium reduction and other nutrition initiatives are central to a broader, whole-of-government approach to help reduce the burden of diet-related chronic diseases and advance health equity.” Read More ➡️ https://hubs.li/Q02LrltL0 #publichealth #nutrition #FDA #foodregulations

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Watch Erica Schlesinger's on-demand talk from the 2024 Global Drug Bioavailability Enhancement/Controlled & Modified Drug Release Summit to explore a comprehensive approach to technology selection for enhanced formulations. Discover strategies for developing scalable and commercially viable formulations from Phase I onwards. Don't miss out on valuable insights into formulation development that considers drug product design right from the start. Click the link to access the presentation and learn more. https://hubs.li/Q02H0qtB0 Key Takeaways: - Strategic drug product design for a flexible Target Product Profile (TPP) to create an advanceable dosage form for First-in-Human (FIH) studies 🧓👶 - Importance of considering TPP/Product Design in amorphous solid dispersion (ASD) screening 🔬💊 - Impact of particle properties (SDD vs HME) on product design and performance🏭 #drugdevelopment #drugproduct #drugmanufacturing

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Why are Natural History Studies important for drug development? Read more here: https://zurl.co/YDfP #ALSP #csf1r #blog #naturalhistory #drugdevelopment

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A recent FDA rule increases regulatory oversight of #LDTs and phases out the use of general enforcement discretion with respect to a significant number of LDTs over a four-year period. Dive into the details of the rule--and what it means for manufacturers of in vitro diagnostics marketed as LDTs--here: https://lnkd.in/eQ2adjif Caroline Williams, Mark Von Eisenburg, MS, Nancy El Hoyek, Laura T. Housman, MPH, MBA, DrPH(c), Brigit Kyei-Baffour, MBA #diagnostics #LDT #labdevelopedtest

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Data are abundant, quality is paramount: The FDA released new draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” – have you seen it? https://bit.ly/4bK6lYv #FDADraftGuidance #InVivoStudies #DataIntegrity

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Pharma Company Gets FDA Green Light For Next Phase Trial For Tourette Syndrome, find out on the latest from Benzinga by Rolando García Bernado. Features SciSparc, FDA - La Administración de Alimentos y Medicamentos, Oz Adler, CPA. #Pharma #Tourette #ClinicalTrial #TouretteSyndrome #BZCannabis.

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April's Horizon Highlight examines biosimilars, the policies impacting their growth in the market, and patient access. #biosimilars #biologics #drugpolicy #healthcare #healthpolicy

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Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals

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Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals

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The CHMP Grants Positive Opinion to Prestige Biopharma Group (Prestige Biopharma / Prestige Biologics)’s Tuznue, Biosimilar of Herceptin #prestigebiopharma #tuznue #breastcancer #gastriccancer #biosimilar #herceptin #trastuzumab #chmp #positiveopinion #phase1 #phase3

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Reviewers and writers on our CMC team delivered high quality chemical and product development reports on time. To learn more, click here: https://bit.ly/cmcwriting #cmc #cmcwriting #ndafiling #fdaapproval #fda #regulatorycompliance #regulatory #regulatoryaffairs #drugsafety #pharmacovigilance #pharma #pharmaceuticals

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Check out our latest work on targeting Histidine residues covalently with aryl -fluorosulfates

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🔬💡 Enhancing Drug Solubility Predictions in Organic Solvent Mixtures Using Machine Learning 🧪🧬 Navigating the complexities of drug solubility in organic solvents is critical for pharmaceutical development. This study by Francesca Cenci, Samir Diab , Paola Ferrini , Catajina Harabajiu , Massimiliano Barolo, Fabrizio Bezzo and Pierantonio Facco introduces a sophisticated machine-learning approach to predict drug solubility in solvent mixtures, leveraging high-throughput experimentation to refine solubility estimates for drug-like molecules. 📊 Utilizing a unique blend of supervised machine learning and quantitative structure–property relationship (QSPR) methodologies, the research focuses on the solubility of active pharmaceutical ingredients (APIs) as influenced by solvent molecular descriptors, functional subgroups, and mixture compositions. Partial Least-Squares (PLS) regression is employed to manage regressors' correlation, enhancing the precision of solubility predictions. Key Insights: 🔎 Advanced Solubility Modeling: Adopts a novel machine-learning framework that treats APIs as unique entities, improving solubility prediction across different solvent compositions and temperatures. 🧮 High Precision: Achieves determination coefficients ≥ 0.90 for solubility predictions in single, binary, and ternary solvent mixtures. 🔄 Validation Success: Tests the model against nine literature datasets of organic solubility, showing superior performance compared to benchmark models 🔍 Reduced Error Metrics: Demonstrates a significant reduction in RMSE ratio compared to benchmark models, confirming the method's robustness and accuracy. 🧪 Industry Application: Provides a scalable solution to predict solubility in industrially relevant solvents, supporting more effective crystallization processes. 📚 Link to Publication: https://lnkd.in/duWn6GhS #DrugSolubility #MachineLearning #Pharmaceuticals #ChemicalEngineering #Innovation #PolyModelsHub

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