While dissolution testing is a primary tool for predicting bioequivalence, several other in vitro methods contribute critical insights, especially for BCS Class II/IV drugs or complex formulations. Below is a list 1. Solubility Studies 2. Permeability Assays 3. Precipitation Kinetics and Supersaturation Studies 4. Dynamic Gastrointestinal Simulation Models 5. In Vitro Lipolysis 6. IVIVC 7….
A Frequently Overlooked Yet Crucial Step in Generic Drug Development. When a formulation is finalized and development stability data is already generated, teams often wonder: Q: “If we manufacture a fresh batch for the pivotal bioequivalence (BE) study, do we need to place it on stability again?” Answer: YES. Absolutely. Even if: The pivotal BE…
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…
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…
While traditional Average Bioequivalence (ABE) works well for most drugs, some cases require advanced approaches. Certain drugs exhibit high intra-subject variability (>30% coefficient of variation, CV), making it difficult to demonstrate BE using traditional methods. SABE is a statistical approach that adjusts BE acceptance limits based on the drug’s inherent variability, preventing unnecessary study failures…
Bioequivalence (BE) studies traditionally rely on pharmacokinetic (PK) parameters, but for locally acting drugs—such as inhalation products, nasal sprays, and topical formulations—systemic drug levels may not reflect therapeutic effect. Thus, alternative BE approaches are essential. Key Methods Pharmacodynamic (PD) Studies – Instead of plasma drug concentration, PD studies measure surrogate markers or direct clinical effects,…
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