When changing the grade of an excipient for different markets the regulatory approach depends on whether the change impacts safety, quality, or efficacy of the drug product. Here’s how to address it for key regulatory agencies: USFDA Filing Type: Documentation: MHRA & EMA Variation Classification: Documentation: MENA Region (Saudi FDA, UAE, Egypt, etc.) Regulatory Approach:…
A BE study may or may not be required, depending on several factors. Here’s a structured approach to determine whether regulatory agencies like the FDA or EMA would require a BE study for this type of qualitative formulation change: Regulatory Perspective on Excipients in Bioequivalence Regulatory agencies consider excipients when evaluating bioequivalence, especially when they…
In formulation development, diluents (or fillers) are often seen as passive ingredients, just there to add bulk, improve compressibility, or adjust dose uniformity. But what if I told you they play critical hidden roles that can make or break a formulation? Here’s a look at some surprising functionalities beyond their textbook definitions: Lactose isn’t just…
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