ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Exploring Lipid Nanoparticles For Drug Delivery

  Using lipid nanoparticles (LNP) for drug delivery is a promising area of research. Discover the benefits of LNP delivery, the different types of lipid nanoparticles, their safety for drug delivery, and more.

• Computational Modeling Of Injection-Related Tissue Responses

  Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

• 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.

• Is It Ever Too Soon To Start Your Performance Testing Assessment?

  Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

• PHI And Medical Devices: What Device Manufacturers Need To Know

  Connected medical devices must treat Protected Health Information (PHI) protection as integral to patient safety and compliance. Understand the data flows and HIPAA requirements to design security.

• Reformulation Of A Complex, High-Drug-Load, Modified Release Dosage Form

  What if you could limit and position a formulation change as only a CMC prior approval supplement under the FDA’s scale-up and post-approval changes guidance?

• Parenteral Packaging And Delivery Systems: Container Closure Integrity

  Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

• A New Mindset For Combination Product Development

  As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

• Designing Delivery Devices For Older Adults With Cognitive Impairment

  Leverage our insights to improve your human factors studies and ensure the effective inclusion of older adults with mild cognitive impairment.

• Transitioning From Vial To Prefilled Syringe

  Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.