ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• NMR And Mass Spectrometry In Pharmaceutical Development

  Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.

• Best Practices For Ensuring Quality In Biologic Products

  New biologic therapies have new challenges in their packaging and delivery systems because of their complexities, higher stability risks, and larger sizes. 

• 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.

• Faster From Formulation To Fill/Finish

  Optimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.

• Delivering On GLP-1 Demand: Combining Device And Supply Strategy

  Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.

• Contract Design And Development Vs. In-House: Finding The Best Fit

  Outsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.

• Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

  A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.

• Patient Adherence With A Novel Dosage Form

  A sprinkle formulation helps patients with tremors or dysphagia take medication more easily, improving adherence, comfort, and care through a novel, FDA-approved oral granule format.

• AI: The New Partner In Medical Device Development

  Involving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals.

• Advancements In GLP-1 Analog Formulation: Overcoming Challenges

  Oral GLP-1 formulations represent a groundbreaking advance in obesity treatment to offer improved patient comfort and adherence while expanding the therapeutic market.