Related Experiment Video
Updated: Sep 20, 2026

An Innovative Method for Exosome Quantification and Size Measurement
Published on: January 17, 2015
Sample size calculation for a proof of concept study
1GlaxoSmithKline, Research Triangle Park, NC 27709, USA. yy0408@gsk.com
Abstract:
Sample size calculation is vital for a confirmatory clinical trial since the regulatory agencies require the probability of making Type I error to be significantly small, usually less than 0.05 or 0.025. However, the importance of the sample size calculation for studies conducted by a pharmaceutical company for internal decision making, e.g., a proof of concept (PoC) study, has not received enough attention. This article introduces a Bayesian method that identifies the information required for planning a PoC and the process of sample size calculation. The results will be presented in terms of the relationships between the regulatory requirements, the probability of reaching the regulatory requirements, the goalpost for PoC, and the sample size used for PoC.
More Related Videos
13:54A Workflow for Lipid Nanoparticle (LNP) Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models (SVEM)
Published on: August 18, 2023
08:58Efficient Sampling of Genetically Encoded Biosensor Design Space Enabled with a Design of Experiments and Automation Workflow
Published on: October 17, 2025
Related Concept Videos
Sample Proportion and Population Proportion
Margin of Error
Sample Size Calculation
The sample size for the given experiment or sampling effort is fundamental to any study design. Sample size decides the number of...
Testing a Claim about Population Proportion
There are two methods of testing a claim about a population proportion: (1) Using the sample proportion from the data where a binomial distribution is approximated to the normal distribution and (2) Using the binomial probabilities calculated from the data.
The first method uses normal distribution as an approximation to the binomial distribution. The requirements are as follows: sample size is large...
Testing a Claim about Standard Deviation
The hypothesis testing for the claim of population standard deviation (or variance) requires the data and samples to be random and unbiased. The population distribution also must be normal. There is no specific requirement on the sample size as the estimation is based on the chi-square distribution.
As a first step, the hypothesis (null and alternative) concerning the claim about...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...