ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products

  Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.

• Trends In Combination Products

  As demand grows for more patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing drug/device combination products.

• The Impact Of PFAS Regulations On Drug Delivery Devices

  By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.

• Navigating PFAS In Medical Devices

  Review how an experienced partner can help you navigate the shifting regulatory landscape for your medical device.

• The Importance Of An Analytical Testing Strategy

  A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.

• Overcome Common Pre-Filled Syringe Challenges Through Partnership

  The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.

• 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.

• 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.

• Unlocking A Patient Preference For Rapid Onset In Treating Migraines

  Examine the case study and learn how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter T_max for the treatment of acute migraine.

• Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway

  Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.