ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 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.

• Combining Powdose® And Diffucaps® For Precise Solid Oral Dosing

  Combining POWDOSE® and Diffucaps® enables precise, individualized solid oral dosing—improving drug delivery, patient compliance, and therapeutic outcomes in personalized medicine applications.

• How To Protect A Modern Silicone Oil-Sensitive Biologic Drug For Self-Injection Of 2.25mL

  A customer experienced expensive project delays when they selected their “tried and tested” large volume, glass syringe system to package a drug to be used in an auto-injector for self-administration.

• 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.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.

• Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing

  This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

• Spray Drying: Advantages And Disadvantages

  When it comes to formulation development, pharmaceutical spray drying is one of the most versatile solutions. Review a detailed look at the steps involved in spray drying and the benefits and downsides.

• Overcoming Challenges In Cell And Gene Therapy Containment

  Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

• Customized Release Through Dispersed Dosage Formats

  Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

• Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

  Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.