Related Experiment Video
Updated: Nov 12, 2025
07:25
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
18.0K
Assessment of Prescribability and Switchability by Using Multiple Bioequivalence Assessment Approaches
Francis Micheal1, Mohanlal Sayana2, Rajendra Prasad3
1Department of Chemistry, School of Advanced Sciences, VIT University, Vellore, Tamilnadu 632014, India.
Drug Metabolism Letters
|March 22, 2021
Summary
A new methoxsalen capsule (MTX test) met average bioequivalence (ABE) criteria but failed population (PBE) and individual (IBE) bioequivalence tests compared to the reference. This study highlights limitations of ABE for drug interchangeability.
Area of Science:
- Pharmacokinetics and Drug Development
- Bioequivalence Studies
- Analytical Chemistry
Background:
- Bioequivalence (BE) assessment is crucial in drug development for evaluating generic drugs.
- Average bioequivalence (ABE) is the standard but may not fully address drug interchangeability.
- Population bioequivalence (PBE) and individual bioequivalence (IBE) offer alternative assessments considering more variance factors.
Purpose of the Study:
- To establish the bioequivalence of a new methoxsalen capsule (MTX test) against a reference formulation (MTX reference).
- To evaluate bioequivalence using multiple methods: average (ABE), population (PBE), and individual (IBE).
- To utilize a novel LC-MS/MS method for pharmacokinetic analysis.
Main Methods:
- An open-label, randomized, crossover, single-dose bioequivalence study in 52 healthy males.
- Administration of 20 mg methoxsalen (MTX test and MTX reference) under fasting conditions.
- Pharmacokinetic parameters and ABE, PBE, and IBE were determined using a validated LC-MS/MS method.
Main Results:
- Both MTX test and reference formulations showed similar pharmacokinetic profiles (Cmax, AUC0-t, AUC0-∞).
- The new methoxsalen capsule met the ABE criteria (80.00%-125.00%) for key parameters.
- However, PBE and IBE assessments indicated bio-inequivalence between the MTX test and reference formulations.
Conclusions:
- While meeting ABE standards, the MTX test capsule was found bio-inequivalent to the reference using PBE and IBE methods.
- Employing multiple bioequivalence assessment methods in a single study offers a novel approach.
- This integrated method may address limitations of traditional bioequivalence assessments for ensuring drug interchangeability.
Related Concept Videos
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
55
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...
55
01:16Bioequivalence: Overview
1.4K
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,...
1.4K
01:13Bioequivalence studies: Biowaivers
69
Body: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...
69
01:16Bioequivalence Data: Statistical Interpretation
65
Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
65
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
66
Body: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...
66
01:17Equivalence: In Vitro and In Vivo Bioequivalence
79
Body: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.
79