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Regulatory Compliance for Global Pharma Market Quality by Design (QbD) in Product Development Dr. Nitin Dharmadhikari Sun Pharma .
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Particle Size Specifications for Solid Oral Dosage Forms: A Regulatory Perspective. ... bioavailability, content uniformity, stability, etc.).
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ANNEX A1 GUIDANCE ON PROCESS VALIDATION SCHEME FOR SOLID ORAL DOSAGE ... Mill Fluid energy mill Impact mill ... uniformity (Assay) – .
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Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and ...
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A GUIDEBOOK TO PARTICLE SIZE ANALYSIS. ... The most obvious example is milling ... characteristics including content uniformity, ...
Blend Uniformity PQRI Research Ajaz S. Hussain, Deputy Director Office of Pharmaceutical Science CDER, FDA Background Blend uniformity analysis (BUA) a in ...
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FDA Adopts, Releases ICH Document on Dose .... the use of the Mass/Weight Variation test as an alternative test for Content Uniformity is not considered ...