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Related Concept Videos

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

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Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
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Equivalence: In Vitro and In Vivo Bioequivalence01:17

Equivalence: In Vitro and In Vivo Bioequivalence

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Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts. Pharmaceutical...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Bioequivalence studies: Biowaivers01:13

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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

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Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
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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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Proposed guidance for carryover studies, based on elementary equivalence testing techniques.

Thomas Keller, Thomas Brinkmann

    Clinical Laboratory
    |August 20, 2014
    PubMed
    Summary

    This study introduces a new statistical method for analyzing carryover effects in clinical analyzers. Equivalence testing demonstrates the absence of carryover, improving method validation in laboratory diagnostics.

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    Area of Science:

    • Clinical Chemistry
    • Laboratory Diagnostics
    • Analytical Chemistry

    Background:

    • Carryover experiments are crucial for validating clinical and immunochemistry analyzers.
    • Current statistical methods for analyzing carryover effects are inadequate, especially for demonstrating absence of carryover.
    • Existing reporting in parts per million (ppm) lacks uncertainty, hindering accurate assessment.

    Purpose of the Study:

    • To propose a step-by-step guidance for the statistical analysis of carryover studies.
    • To introduce a novel statistical design based on equivalence testing for carryover data analysis.
    • To provide a practical, sample-based tutorial for implementing the proposed methodology.

    Main Methods:

    • Employed a one-sided equivalence testing approach, a form of non-superiority testing.
    • Compared the observed carryover difference against a predefined limit.
    • Demonstrated the methodology using total beta-hCG measurements on a UniCel DxI 880 analyzer.

    Main Results:

    • Developed a new statistical approach for analyzing carryover study data using equivalence testing.
    • Determined that 8 (11) cycles of high/low concentration samples provide 80% (90%) power to validate absence of carryover at alpha=0.05.
    • Proposed defining acceptance criteria based on the imprecision of unaffected low-concentration samples.

    Conclusions:

    • Appropriate statistical methods are essential for method validation, particularly for demonstrating absence of effect, non-inferiority, or equivalence.
    • One-sided equivalence testing is the correct statistical model for carryover studies.
    • The proposed methodology is applicable to various experimental approaches, including method comparison, commutability, and robustness studies.