Changing the API source requires evaluating its impact on safety, efficacy, stability, and manufacturability. Below are the key factors to assess: Physicochemical Properties Dissolution & Bioavailability Stability Considerations Regulatory & Compliance Manufacturing & Process Impact In-vivo Considerations Risk Assessment & Final Decision Conclusion API source changes demand scientific, regulatory, and process evaluations to prevent any…
In pharmaceutical development, a drug’s success depends not only on its formulation but also on how efficiently it reaches the bloodstream. One of the most critical yet often overlooked factors? Dissolution testing and its direct impact on pharmacokinetics (PK). What’s a Dissolution Profile? Dissolution testing simulates how a tablet releases its active ingredient in the…
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:…
Filing a Paragraph IV (Para IV) certification for a generic drug requires either proving non-infringement or challenging the validity of the patent covering the reference listed drug (RLD). A deep understanding of independent and dependent claims is crucial to designing around a patent. Understanding Patent Claims Patent claims define the legal protection granted to an…
SUPAC Guidance on Qualitative Changes The USFDA SUPAC (Scale-Up and Post-Approval Changes) guidance categorizes formulation changes based on their impact on product performance. A qualitative change refers to the replacement or removal of an excipient, classified as a Level 3 change, which is considered major and requires regulatory approval. Key Regulatory Requirements for Level 3…
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…
