ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Compliance Considerations For Emergency-Use Delivery Systems

  Because auto-injectors are typically the delivery device of choice for emergency medications, they come with increased scrutiny from regulatory bodies regarding their safety and effectiveness.

• Small-Scale Aseptic Filling Technology Considerations

  Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.

• Pediatric Dosage Form Development: Program Design And Formulation Development

  Explore key considerations to successfully bridge from initial concept of pediatric program design and formulation development strategies into later stages of development and through to commercialization.

• Nanosuspension Dosage Forms: Product Development & Scale Up

  For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.

• Sterile Injectable Therapies: Revolutionizing Lifecycle Management

  The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• How Devices, Instructions, And Packaging Work Together To Improve Safety

  A medical device's user interface is the entire product system: the device, labeling, packaging, and IFU. These elements are crucial for risk mitigation and must be tested holistically.

• How To Achieve Precise And Flexible Dosing With Multiparticulates

  For orally delivered medicines, developers often must balance a drug’s “curb appeal” — its specific delivery mechanism, taste, ease of administration, and convenience — with safety and efficacy.

• Ophthalmic Formulation Development: Inside Ophthalmic Preparation

  Understand why the demand for CDMOs with experience in the formulation of ophthalmic products is on the rise. 

• Opioid Reformulation Filed As A CMC Supplement In Less Than A Year

  Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.