Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.

This report summarizes podium presentations and breakout sessions from the second day of the 2019 M-CERSI workshop on In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, and When? Presenters from the U.S. Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), Brazilian Health Surveillance Agency (ANVISA), and the pharmaceutical industry shared experiences/concerns with dissolution profile similarity assessment supporting minor/moderate Chemistry, Manufacturing and Control (CMC) changes.

Disintegration testing augmented by computer Vision technology.

Oral solid dosage forms, specifically immediate release tablets, are prevalent in the pharmaceutical industry. Disintegration testing is often the first step of commercialization and large-scale production of these dosage forms. Current disintegration testing in the pharmaceutical industry, according to United States Pharmacopeia (USP) chapter 〈701〉, only gives information about the duration of the tablet disintegration process.

Determining the Sources of Variance in the Preparation of Analytical Standards for Chromatographic Analysis of a Lyophilized Peptide Drug Substance by Nested ANOVA Statistical Analysis.

Synthetic peptides used as therapeutic medicines is continuing to grow as an area of focus within the pharmaceutical industry due to specificity and potency. As such, quality control areas need to continue to advance their capabilities to ensure that appropriate analyses are being performed, and that the data generated are both accurate and precise. One area which poses a significant challenge compared with traditional small molecule drug products is having a highly robust, low variability method of quantifying the assay of the active substance.

Strategies of bringing drug product marketing applications to meet current regulatory standards.

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards.

Development and validation of a high-throughput GC measurement for water activity.

The development and validation of a headspace GC method to measure the water activity of pharmaceutical samples is presented. Thermal and moisture transfer equilibration rates are shown to be critical variables in the measurement. Several different calibration schemes are discussed with their advantages and disadvantages.