Two statistical concepts, confidence intervals and prediction intervals, play distinct roles in understanding the variability of data and making informed decisions. This article explores the differences between these intervals and discusses their relevance in specification setting for pharmaceutical products.

GraphPad, a renowned software platform, has emerged as a powerful and user-friendly tool for graphing and statistical analysis. In this article, we will explore the multifaceted utility of GraphPad in the pharmaceutical sector.

In GMP, documentation is important. Your Excel spreadsheet should be created and maintained following good documentation processes. Read the following tips that you can follow in order to guarantee data precision and adherence to regulations.

In the laboratory, data integrity is paramount, especially in industries subject to GMP regulations. Excel spreadsheets have become indispensable tools for data management, analysis, and reporting. These spreadsheets must undergo a rigorous process of validation to ensure regulatory compliance.

Scientists often spend countless hours manually creating graphs to visualize and interpret their data. An automated dissolution graph builder in Excel simplifies the process of creating dissolution graphs.

Setting reliable and appropriate specifications for dissolution testing is essential for ensuring that the drug product is consistent in quality and performance.

To comply with dissolution requirements, the quantity of active ingredient dissolved from the tested dosage units must align with the specifications provided in the FDA guidance.

In the pharmaceutical industry, dissolution testing is a crucial step in the development and quality control of dosage forms.

Tablet dosage forms often include one or more scores, which serve a valuable purpose. Ensuring consistent scoring allows the patient to adjust the dosage by splitting the tablet.

The consistency of dosage units can be shown through one of two methods: content uniformity and weight variation. This article discusses how content uniformity test is performed.

The consistency of dosage units can be shown through one of two methods: content uniformity and weight variation. This article discusses how weight variation analysis is performed.

Tablet dosage forms often include one or more scores, which serve a valuable purpose. Ensuring consistent scoring allows the patient to adjust the dosage by splitting the tablet.

One criterion that new products with scores must adhere to is tablet splitability, which is measured at both ends of the proposed hardness range.

Friability refers to the tendency of a tablet to chip, crumble, or break during transportation. USP <1216> Tablet Friability shows the guidelines for determining the friability of compressed, uncoated tablets.

Raw data from Empower typically contains a ton of information that we do not need and extracting the important data can be a time-consuming task.

This calculator can quickly calculate values for f1 and f2. By utilizing this tool, scientists can significantly reduce the time required for calculations.

The void volume is the volume that the mobile phase occupies in a column. To accurately determine the void volume of a particular column, you must inject an unretained compound that has no or little retention.

In dissolution testing, f1 difference and f2 similarity calculations are used to compare one formulation to another or a reference batch.