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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024

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New safety information for healthcare professionals Veoza (fezolinetant): new recommendations to minimise risk of liver injury The PRAC has agreed to a direct healthcare professional communication (DHPC) informing of the risk of drug-induced liver injury (DILI) with Veoza (fezolinetant) and has recommended monitoring of liver function before and during treatment. Veoza is a medicine used to treat moderate-to-severe vasomotor symptoms (also referred to as hot flushes or night sweats) associated with menopause. The committee considered a review of the potential risk of fezolinetant to cause drug-induced liver injury based on information from all available sources, including reports of suspected side effectsand studies published in the scientific literature. Severe elevations of the liver enzymes alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (>10x upper limit of normal) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) have been reporte...
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Pharmaceutical Manufacturing

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 Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. It involves a series of steps to ensure that the medications produced are of high quality, safe, and effective for patient use. The process encompasses several critical stages, including: Research and Development (R&D): Discovery: Identification of new chemical entities or biological products through research. Preclinical Testing: Laboratory and animal testing to evaluate safety and efficacy. Clinical Trials: Testing in human subjects to confirm safety and effectiveness. Formulation Development: Drug Formulation: Designing the composition of the drug, including active ingredients and excipients (inactive ingredients). Dosage Form Design: Creating the final product form (e.g., tablets, capsules, injectables). Manufacturing Process: Active Pharmaceutical Ingredient (API) Production: Chemical synthesis or biological processes to produce t...
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How Dynamic Streaming Potential Can Take Formulation Science to the Next Level — Free Webcast

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What physico-chemical properties do your formulas have? Will they remain stable? Do their viscosities, performance, etc., endure changes in pH or temperature?Physico-chemical property analysis is one way to predict their behaviors. As ingredient supplier Seppic explains on its website, "physico-chemical tests are used to characterize properties, anticipate behavior in formulation and measure performance . .. under real usage conditions." The company adds that such tests also help to optimize the ingredient or formula structure, guiding the product developer to make adjustments that achieve the functionality and behavior desired by end users.More specifically, as Calixto and Maia Campos report, rheological, texture and sensory analyses are important to understanding the behavior and stability of formulations. Cheung, et al., even proposed the creation of products based on their constituents and microstructure, rather than traditional trial-and-error and screening formula var...
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