ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 5 Novel Techniques For Solubility Enhancement

  Thanks to insoluble drug delivery technologies, the practice of reformulating poorly soluble drug products to improve efficacy, patient compliance and safety has now been widely adopted.

• Which Testing Does An Effective Certificate Of Analysis Include?

  Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

• The Challenges And Opportunities Of Real-World Evidence

  The FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.

• 4031 Ready Methods Reduce E&L Timelines

  An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

• Solubility With Lipid-Based Technologies For Oral & Injectable Formulations

  Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.

• The Future Of Pharma Packaging Trends, Technologies, And Patient-Centric Solutions

  Pharmaceutical packaging must evolve alongside drug development to ensure stability, safety, and regulatory adherence, utilizing innovative designs to improve therapeutic outcomes and patient accessibility.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

• An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals

  Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.

• Improved Biomanufacturing Processes And Drug Product Stability

  Improve upstream media for bioavailability and foam stability, downstream buffers for purification, and the formulation and final fill drug product stability with this highly interdisciplinary process.