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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

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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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Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
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Factors Influencing Bioavailability: First-Pass Elimination01:23

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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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Noncompartmental Analysis: Miscellaneous Pharmacokinetic Parameters00:54

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The noncompartmental approach is a widely used method in pharmacokinetics to assess drugs' behaviors in the body. It considers several factors, including clearance, bioavailability, and total volume of distribution.
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Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative

Sara Carolina Henriques1,2, Paulo Paixão1, Luis Almeida2

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

Pharmaceutics
|October 28, 2023
PubMed
Summary

Pilot bioavailability/bioequivalence studies can use a geometric mean (Gmean) f2 factor for better decision-making. This method aids in determining if pivotal studies are needed, especially with higher variability.

Keywords:
bioequivalencegeneric medicinal productsmodelling and simulationpharmacokinetic simulationpharmacokineticspilot studiesƒ2 factor

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Area of Science:

  • Pharmacokinetics and Drug Development
  • Biopharmaceutical Sciences
  • Regulatory Science

Background:

  • Pilot bioavailability/bioequivalence (BA/BE) studies are crucial pre-pivotal trials, typically enrolling 12-18 subjects without formal sample size calculation.
  • Previous work suggested using the geometric mean (Gmean) f2 factor for pilot BA/BE data evaluation, showing promise for Cmax assessment under specific conditions.

Purpose of the Study:

  • To evaluate the proposed Gmean f2 factor method against standard average bioequivalence in more extreme scenarios for pilot BA/BE studies.
  • To assess the utility of the Gmean f2 factor in decision-making for proceeding to pivotal bioequivalence studies.

Main Methods:

  • Simulated pilot BA/BE crossover studies using population pharmacokinetic modeling with varying inter-occasion variability (IOV) levels.
  • Compared the Gmean f2 factor with standard average bioequivalence under diverse true geometric mean ratios (GMRs) for bioequivalent and bioinequivalent formulations.

Main Results:

  • A redefined decision tree is proposed, recommending a fixed sample size of 20 subjects for pilot studies when intra-subject coefficient of variation (ISCV%) is >20% or unknown.
  • The Gmean f2 factor method is suggested for use alongside average bioequivalence when the 90% confidence interval for GMR falls outside the [80.00-125.00]% acceptance range.

Conclusions:

  • The Gmean f2 factor approach provides valuable insights into the certainty of proceeding with pivotal BA/BE studies based on pilot study results and variability.
  • This alternative method aids in optimizing decisions for pivotal bioequivalence study progression, especially in challenging variability scenarios.