Bioequivalence (BE) studies are typically conducted in a single-dose design, but in some cases, steady-state BE studies are required to ensure therapeutic equivalence. When Are Steady-State BE Studies Needed? Drugs with Non-Linear Pharmacokinetics Drugs with a Long Half-Life Modified-Release (MR) Formulations Enzyme Inducers or Autoinduction Drugs Narrow Therapeutic Index (NTI) Drugs Regulatory Perspective Study Design…
The choice of Bioequivalence (BE) study design depends on several factors, including the pharmacokinetics (PK) of the drug, its variability, dosage form, and regulatory requirements. Here’s a detailed breakdown of how to select the appropriate BE study design. Standard Two-Way Crossover Design Replicate Crossover Design Parallel Study Design Steady-State BE Study Design Partial Replicate Design…
BE studies for clear oral syrup solutions ensure that generic formulations provide the same therapeutic effect as the reference product. Unlike solid dosage forms, oral syrups are already in solution, which simplifies some BE requirements. However, factors such as excipients, solubility, and absorption characteristics can influence the need for in vivo studies. When Are BE…
Pilot BE Study with Two Dosing Strategies To optimize the formulation before the pivotal BE study, two pilot BE studies are conducted with different dissolution behaviors: Strategy 1: Formulation with Matching Dissolution in Discriminating Media Strategy 2: Formulation with Faster or Slower Dissolution (Depending on Dosage Form) Pilot BE Study Strategy Study Design Dosing Strategies:…
HvD pose a unique challenge in generic drug development due to their high intra-subject variability (CV > 30%) in pharmacokinetics. This variability complicates BE studies, requiring different regulatory agencies to adopt distinct approaches to ensure therapeutic equivalence without clinical hurdles. Key Regulatory Approaches for HvD Generic Drug Approval USFDA Approach – Reference-Scaled Average Bioequivalence (RSABE)…
Bioequivalence (BE) studies are crucial in the pharmaceutical industry to ensure that generic formulations exhibit comparable bioavailability to their reference products. Several factors influence BE results, potentially impacting regulatory approval and market entry. This review highlights the key determinants affecting BE outcomes, including formulation characteristics, physiological variability, study design, and analytical considerations. Formulation Factors The…
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