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,…
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…
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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