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Related Concept Videos

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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...
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

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...
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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 indication due to...
Crossover Experiments01:16

Crossover Experiments

Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

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Updated: May 8, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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The road not taken: transferability issues in multinational trials.

Pepijn Vemer1, Maureen P M H Rutten-van Mölken

  • 1Institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, PO Box 1738, 3000 DR, Rotterdam, The Netherlands, pepijnvemer@gmail.com.

Pharmacoeconomics
|August 28, 2013
PubMed
Summary

National regulatory agencies struggle to use cost-effectiveness (CE) data from multinational trials for drug reimbursement decisions. Simpler methods are often used, despite advanced statistical approaches existing to improve country-specific CE estimates.

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Area of Science:

  • Health Economics
  • Pharmacoeconomics
  • Clinical Trial Analysis

Background:

  • National regulatory agencies rely on cost-effectiveness (CE) data from multinational randomized controlled trials (RCTs) for drug reimbursement decisions.
  • Estimating country-specific CE from multinational RCTs requires effective utilization of patient-level data.
  • Existing methods for CE estimation range from simple to statistically complex.

Purpose of the Study:

  • To investigate the methods used for estimating CE ratios in economic evaluations alongside recent multinational RCTs.
  • To assess the application of different statistical approaches in multinational RCTs with at least 500 patients.

Main Methods:

  • Systematic literature review of studies performing economic evaluations alongside multinational RCTs.
  • Classification of studies based on the origin of resource use, unit costs, health outcomes, and utility value sets (one country, subset, or all countries).
  • Recording of trial-wide and country-specific CE results and statistical analyses employed.

Main Results:

  • Majority of 21 included studies used data from all countries for health care utilization and outcomes.
  • Thirteen studies used one-country valuation for health care utilization; six used multi-country valuation.
  • None of the studies presenting quality-adjusted life-years (QALYs) utilized multi-country valuation; inconsistency in valuation methods was observed.
  • Eleven studies calculated country- or region-specific CE estimates, with 13 using simpler methods and 8 employing advanced statistical techniques.
  • Five studies utilized hierarchical data structures for more appropriate estimates and improved transferability.

Conclusions:

  • The adoption of advanced statistical methods for CE estimation in multinational RCTs has been slow.
  • Simpler, less sophisticated methods are still routinely used, potentially limiting the accuracy of country-specific CE estimates.
  • There is a need to improve the application of advanced statistical methods to enhance the reliability of CE data for reimbursement decisions.