ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Pharmaceutical Nanotechnology: What To Know

  Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.

• Stability Chambers: Testing, Equipment, And Uses

  Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• A Smarter Strategy For Optimizing Oncology Drug Products

  John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.

• Nose To Brain (N2B) Drug Delivery – Benefits And Challenges

  Delve into the growing interest in drug delivery methods that target the brain and central nervous system via absorption into the bloodstream, specifically focusing on crossing the blood-brain barrier (BBB).

• Which Testing Does An Effective Certificate Of Analysis Include?

  Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

• FAQs On The Revised EU GMP Annex 1: Volume 8

  Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

• 4031 Ready Methods Reduce E&L Timelines

  An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.

• Building Sustainability Into Medical Devices

  Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance.

• A Practical Packaging Components Checklist For Emerging Biotechs

  A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.