Good Identification Practices for Organic Extracables and Leachables via Mass Spectrometry
The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.
ADVANCEMENTS IN GLP-1 ANALOG FORMULATION DEVELOPMENT: OVERCOMING CHALLENGES IN ORAL DELIVERY
February 14th 2025Obesity is a significant global health challenge that requires lifestyle changes and effective pharmacological treatments to overcome. Human glucagon-like peptide 1 (GLP-1) analogs, also called incretin mimetics, have emerged as a promising obesity treatment option. Additionally, oral GLP-1 formulations represent a groundbreaking advance in obesity treatment, offering greater patient comfort and adherence to expand the therapeutic market.
Flexible-Dose Development Strategies for Today's Clinical Landscape - Executive Summary
January 8th 2025This executive summary focuses on dose-flexible manufacturing strategies and their role in drug development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized early in development. This presentation will focus on technical strategies that can help anticipate appropriate timing for implementation and how to do so cost effectively while adhering to required timelines.
