Newsletter | March 17, 2025

03.17.25 -- Managing Risk When Developing Combination Products

FEATURED EDITORIAL

Managing Risk When Developing Combination Products

In this episode, host Tom von Gunden discusses Chapter 6 on risk management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Edwin Bills.

5 Major Regulatory Focuses For Medical Device Compliance

Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be preparing.

INDUSTRY INSIGHTS

Mitigating Risks To Drug Stability And Efficacy: Extractables And Leachables

Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

Advancing GLP1 Analog Formulation To Overcome Oral Delivery Challenges

Oral GLP-1 formulations represent a groundbreaking advance in obesity treatment, offering improved patient comfort and adherence while expanding the therapeutic market.

Answering Migraine Patients’ Call For Rapid Action Oral Treatments

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

Identify And Mitigate Drug Absorption Risks Early With PBPK Modeling

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Financial Considerations For Phase 2 Clinical Injectable Drug Manufacturing

Uncover the importance of scalability and flexibility in early-stage manufacturing strategy and how that decision impacts financial outcomes for a development program.

Prefilled Syringes Market Trends: Improving Patient Experience

Learn how sterile injectable devices are providing safer and more convenient self-injection delivery, leading to positive patient experiences, better therapy adherence, and improved outcomes.

SOLUTIONS

Technology To Overcome Absorption Hurdles And Solubility Limitations

Bolstering Bioavailability With Advanced Formulation And Analytics

EZ-fill Smart: The Enhanced Version Of Ready-To-Use Vial Platform