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ICH Q6B for Analytics

PharmTech

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Labeling for the primary and secondary labels are determined.

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How AI Brings Pharmacogenetics to the Frontline of Precision Medicine

Pharmacy Times

This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. Real-World Evidence, Emerging Therapies, and Demonstrating Value Technological advances are accelerating this progress.

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FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

The manufacturer reported that, as part of the NDA review, they have not highlighted any technical concerns related to the submitted documentation or testing of OLC. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

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Obesity Medication Use Remains Low Among Children | ADA 2025

Drug Topics

image credit: syahrir / stock.adobe.com While data shows that obesity has been on the rise among children in recent history, the overall complications spurred on by childhood obesity have been well documented. of YA with obesity were prescribed OMs—predominantly GLP-1s approved for adults but used off label for younger people.

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The GLP-1 Gold Rush: Why Compounded Alternatives Are a Risky Bet

Pharmaceutical Commerce

Existing policies often feature explicit exclusions for non-FDA approved products or harm from off-label use. Implement and meticulously document robust quality control and assurance processes internally. For the few willing to offer coverage, 5 premiums are substantially elevated with higher deductibles. Subscribe Now!

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Victoza vs. Saxenda: Differences, similarities & side effects

The Checkup by Singlecare

However, healthcare providers can prescribe them “off-label” for other conditions. Compare Victoza vs. Saxenda conditions treated Condition Victoza Saxenda Type 2 diabetes Yes Off-label Obesity Off-label Yes Type 1 diabetes No No Is Saxenda better than Victoza? What conditions are treated by Victoza vs. Saxenda? Shuxiao says.