Retrospective chart reviews: Assessing delays in IRB approval

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Run charts serve as an essential instrument for visualizing the performance of various processes over time, enabling the identification of trends and patterns crucial for quality improvement. These charts map out a series of data points chronologically, offering insights into the stability and efficiency of a process. A run chart's creation involves plotting data points on a graph, with the time intervals on the horizontal axis and the specific measurements on the vertical axis. For...

In statistical process control, control charts, particularly R charts, are instrumental in monitoring process variations and identifying non-random patterns that run charts might miss. R charts track the variability within process subgroups, which is crucial when standard deviation use is impractical or unknown process variations exist.
R charts are pivotal for pinpointing shifts in process variability. Stability is indicated when all data points remain within the defined upper and lower...

A Pareto chart is a bar graph or a combination of both line and bar graphs. The bar lengths represent the individual values or the frequency, while the lines represent the cumulative total values. In this chart, the longest bars are arranged on the left and the shortest bars on the right, which makes it easier to read and interpret the data. It can also be called a Pareto diagram or Pareto analysis.
The Pareto chart is named after the Italian economist Vilfredo Pareto, who described the Pareto...

R chart, or range chart, is a fundamental tool in statistical process control used to monitor the variability within a process. It complements the X-bar (x̄) chart by focusing on the range of the data, rather than individual values, providing a clear picture of the process dispersion over time.
An R chart plots the range of subsets of measurements collected from a process. Each point on the chart represents the range—defined as the difference between the maximum and minimum...

In statistics, several tools are used to interpret the data. Measures of central tendency represent the characteristics of the data, such as mean, median, and mode. Additionally, measures of variance like standard deviation and range are used to find the spread of data from the mean. Relative standing measures the distance between data locations. Commonly used measures of relative standings are percentile, z score, and quartiles.
Percentiles are a type of fractile that partition data into...