Featured Pharma Online Editorial

1. Is Charisma An API? 11/19/2025

   After nearly 20 years in the pharmaceutical industry, Samir Shah, director of regulatory CMC for medical products and combination products at AstraZeneca, knows how beneficial charisma can be for the pharmaceutical professional. That’s why he presented the topic at the 2025 RAPS Convergence.

2. Derisking AI Means First Asking: Who Does It Serve? 9/26/2025

   Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.

3. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

   The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

4. Avoiding Alcohol-Induced Dose Dumping In Oral Drug Formulation 8/21/2025

   The FDA has become more vigilant about alcohol-induced dose dumping in extended-release oral dosages. Such dumping can result in anything from reduced therapeutic effects to dangerous toxicity. Let's take a closer look.

5. Reimagining Psychedelics: Mental Wellness Without the Roadblocks 8/19/2025

   The rising incidence of mental health disorders brought the mental health benefits of psychedelics back into the spotlight, and we are currently at a watershed moment.

6. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

   A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

7. What Did ICH Q14 Miss On Analytical Method Validation? 7/7/2025

   Revisions to ICH Q14 remedied some shortcomings, but the latest version still contains errors and ambiguities. Here is a detailed breakdown.

8. Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet 6/19/2025

   This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.

9. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

   Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

10. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

    The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).