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Bioequivalence: Overview01:16

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Bioavailability refers to the proportion of an unaltered drug that, after administration, enters the systemic circulation and can be distributed to the desired action site. Factors such as gastrointestinal (GI) absorption and liver biotransformation influence the bioavailability of a drug when it is administered orally. When a drug is administered intravenously, it enters the systemic circulation directly; by definition, its bioavailability is assumed to be 100%. The bioavailability of an...
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Drug disposition in the body is a complex process and can be studied using two major approaches: the model and the model-independent approaches.
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When a drug is taken orally, it undergoes a journey starting from the gastrointestinal (GI) tract, passing through the portal vein, reaching the liver, and finally entering the systemic circulation. This process involves the absorption of the drug across the GI tract. The liver is the primary site for metabolizing the drug, with some metabolism also occurring in the gut wall. This journey significantly reduces the quantity of the drug that reaches the systemic circulation, a phenomenon known as...
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Alternative Analysis Approaches for the Assessment of Pilot Bioavailability/Bioequivalence Studies.

Sara Carolina Henriques1,2, João Albuquerque2,3, Paulo Paixão1

  • 1Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, 1649-003 Lisboa, Portugal.

Pharmaceutics
|May 27, 2023
PubMed
Summary

Pilot bioavailability/bioequivalence (BA/BE) studies benefit from alternative analysis methods. The geometric mean ƒ2 factor approach offers more accurate conclusions on test formulation potential with smaller sample sizes.

Keywords:
bioequivalencebootstrapgeneric medicinal productspharmacokinetic simulationpharmacokineticspilot studiesƒ2 factor

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Area of Science:

  • Pharmacokinetics and Pharmaceutical Sciences
  • Drug Development and Regulatory Science

Background:

  • Pilot bioavailability/bioequivalence (BA/BE) studies typically use average bioequivalence, which is sensitive to variability due to small sample sizes.
  • This sensitivity can lead to uncertainty in conclusions regarding test formulation potential.

Purpose of the Study:

  • To propose and evaluate alternative analytical approaches for pilot BA/BE studies.
  • To reduce uncertainty and improve the reliability of conclusions from small-scale BA/BE trials.

Main Methods:

  • Simulated pilot BA/BE crossover studies using population pharmacokinetic modeling.
  • Compared average bioequivalence with alternative methods: geometric least square means ratio (GMR), bootstrap analysis, and arithmetic/geometric mean ƒ2 factors.
  • Evaluated method performance using a confusion matrix.

Main Results:

  • The geometric mean ƒ2 factor (Gmean ƒ2) with a cut-off of 35 demonstrated the highest accuracy in determining test formulation potential under simulated conditions.
  • This method allows for more reliable conclusions with reduced sample sizes compared to traditional approaches.

Conclusions:

  • The Gmean ƒ2 factor is a suitable alternative for analyzing pilot BA/BE studies.
  • A decision tree is proposed to guide sample size planning and analysis approach selection for pilot BA/BE trials.