Design Considerations for Bioequivalence Studies

Free Webinar
Design Considerations for Bioequivalence Studies
Cross-over Design Choices, Boundary Selection and Determining Sample Size

In this webinar, Denis Desmond, Research Statistician at nQuery, explores how to design effective and regulatory-ready bioequivalence studies by focusing on three essential areas:

1. Choosing the Right Crossover Design for Bioequivalence

2. Addressing Variability and Design Complexities

3. Accurate Sample Size Planning Using nQuery

Learning objective of this webinar:

 In this webinar you will get an overview of bioequivalence studies, crossover trials, their advantages and disadvantages, and some of the crossover designs. This webinar also covers sample size determination for crossover trials and demonstrates several worked examples in nQuery.

Bioequivalence studies are a type of clinical trial in which the goal is to demonstrate that there is no significant difference between two formulations of a drug for the rate and extent of absorption of the active compound, i.e., that the two formulations have equivalent bioavailability. Bioequivalence studies are a key element of generic drug development, and most commonly utilise crossover trial designs. 

Key Statistical Approaches Covered in This Webinar

Selecting the Right Design for Bioequivalence

• Overview of standard and replicate crossover designs (e.g., 2x2, 3x3, 2x4)

• Matching study design to drug characteristics (e.g., high variability, narrow margins)

• Regulatory considerations for design choice (FDA, EMA guidance)

Addressing Design Pitfalls in Bioequivalence Trials

• Handling high intra-subject variability and carry-over effects

• Common mistakes in washout periods and treatment sequencing

• Design adaptations to avoid study failure or rejections

Accurate Sample Size Planning

• Methods for calculating appropriate sample size for equivalence testing

• Understanding power, variability, and their influence on sample size

• Step-by-step nQuery demonstrations for real-world BE scenarios

About nQuery

nQuery helps make your clinical trials faster, less costly and more successful. It is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures.

nQuery Solutions

• Sample Size & Power Calculations: Calculate for a Variety of frequentist and Bayesian Design
• Adaptive Design: Design and Analyze a Wide Range of Adaptive Designs
• Milestone Prediction: Predict Interim Analysis Timing or Study Length
• Randomization Lists: Generate and Save Lists for your Trial Design

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