Measurement uncertainty for <711> Dissolution tests using Monte Carlo methods - Uncertainties arising from sampling and analytical steps.

Background: The dissolution test is a critical quality control method in the pharmaceutical industry, primarily used to assess drug bioavailability and ensure the consistency of manufactured batches. This test simulates the release of the active ingredient in the body and verifies compliance with specifications through multiple stages (e.g.

Measurement uncertainty for < 905 > Uniformity of Dosage Units tests using Monte Carlo and bootstrapping methods - Uncertainties arising from sampling and analytical steps.

Uniformity of dosage unit (UDU) test is widely used to assess the quality, safety, and effectiveness of dosage forms in unit doses. An increased variability of the amount of drug (API - Active Pharmaceutical Ingredient) in each dose unit may lead to low quality, unsafety, and ineffective medicines. The aim of this work was to evaluate the measurement uncertainty associated with the acceptance value (AV) using the Monte Carlo and Bootstrapping methods, as well as to estimate the risk of false decisions regarding compliance/non-compliance due to uncertainty.