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…
Today, let’s dive into the intricate world of overcoming solubility challenges in drug formulation. Join me as we explore the hurdles posed by poor solubility and the ingenious strategies formulated by scientists to tackle this pervasive issue. Solubility Challenges Formulation Strategies Nanosuspensions: Solid Dispersions: Cyclodextrin Complexation: Overcoming solubility challenges is pivotal in developing effective therapies….
In pharmaceutical development, FaSSIF and FeSSIF replicate intestinal conditions in fasting and fed states, aiding in predicting drug dissolution, absorption, and bioavailability. FaSSIF (Fasted State Simulated Intestinal Fluid) Purpose: Key Characteristics: Composition: Application: FeSSIF (Fed State Simulated Intestinal Fluid) Purpose: Key Characteristics: Composition: Application: Why Are These Media Important? Biorelevant Dissolution Testing: Food Effect Studies:…
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…
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