Viscosity plays a particularly critical role—especially when the goal is to demonstrate bioequivalence (BE) with a Reference Listed Drug Key functions of viscosity in suspensions: Bioequivalence Considerations BE studies are conducted to ensure that the rate and extent of drug absorption from a generic product are comparable to that of the RLD. For BCS Class…
Every successful generic drug starts with one essential step — understanding the innovator. Innovator Product Testing is where science meets strategy. Before formulation begins, this stage provides a complete technical blueprint of the reference product. Here’s what it entails: 1. Physical Testing — More Than Just Dimensions We analyze the innovator tablet for: These parameters…
In pharmaceutical development, what you know before you start determines how far—and how fast—you go. The Handbook of Pharmaceutical Generic Development underscores the literature search as the first strategic pillar of generic drug development. It’s not just academic—it’s operational intelligence. Here’s what a high-quality literature search accomplishes: Establishes the Regulatory Landscape Knowing the regulatory path…
Forced degradation studies are more than a regulatory checkbox—they are a cornerstone of quality assurance, designed to reveal the intrinsic stability of a molecule and its behavior under stress. Yet, their potential is often underutilized due to common yet avoidable pitfalls. Key Insights into Frequent Challenges Inadequate Stress Conditions The art of forced degradation lies…
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:…
Poly(lactic-co-glycolic acid) (PLGA) is a widely used polymer in drug delivery systems, particularly for creating long-acting injectable microspheres. A crucial factor influencing the drug release profile of these formulations is the glass transition temperature (Tg), which represents the temperature at which PLGA transitions from a hard, glassy state to a softer, rubbery state. Impact of…
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