Featured Pharma Online Editorial
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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Lilly's Calculated Approach To Upgrade Trade-Offs
5/22/2025
If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.
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First AMT Program OK'd Under New FDA Designation — Here's What To Know
5/21/2025
The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.
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ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy
5/12/2025
Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.