Compounds relative response factors– the impact of a wrong quantification during E&L testing

Time: 12:10 pm - 12:30 pm

Date: 18 September 2019

18-september-2019 12:10 18-september-2019 12:30 Europe/London Compounds relative response factors– the impact of a wrong quantification during E&L testing

The importance of extractables and leachables testing in the pharmaceutical industry has grown significantly in the last few years driven by a substantial growth in global regulatory requirements. A drug product container-closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity, or affect… Read more »

Making pharmaceuticals Milano

Synopsis

The importance of extractables and leachables testing in the pharmaceutical industry has grown significantly in the last few years driven by a substantial growth in global regulatory requirements. A drug product container-closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity, or affect its stability or efficacy. Substances may migrate from different materials and
patients may be exposed through different routes of administration. During the drug development process it is important to evaluate the potential for various chemicals to migrate. Risk assessment of product configuration or manufacturing chain should be performed as well as a proper toxicological evaluation.
Regulatory agencies require extractables and leachables testing to identify any risks of product adulteration. One of the most critical aspects of Extractables & Leachables studies is related to the correct estimation of compounds concentration. An underestimation of concentration could negatively impact risk assessment reason why it’s absolutely necessary to be able to implement a valid approach for an accurate quantification of the migrated compounds.
Obiettivi di apprendimento
• Concentration rescaling of the chemical compounds based on relative response factors, to have a more precise quantification in the extractables assessment.
• Fill the gap between the necessity of using screening methods and the quantitative data reliability.
• Have more precise data on which set the an appropriate toxicological evaluation.
• Avoiding of false positives which lead to unfounded concerns, and false negatives which lead to the missing of the proper alerts.

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