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The Pharmaceuticals and Biopharmaceuticals industry focuses on the discovery, development, manufacturing, and commercialization of medicinal drugs and biologic products (like vaccines, antibodies, and cell/gene therapies) intended to diagnose, treat, mitigate, or prevent diseases.
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Labs are under pressure to deliver results that are not only accurate but also traceable, defensible, and structured for global compliance.
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As regulatory bodies like the FDA and USP continue to emphasize method validation and bioequivalence, laboratories must ensure their dissolution testing practices are scientifically sound and regulatory compliant.
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