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🔗 Source: inhalationmag.com
📊 Size: 874 KB
👤 Author: Benjamin Weber
⬇️ Downloads: 204

Summary

Objective methods for evaluating the equivalence of aerodynamic particle size distributions (APSD) are crucial for determining whether a generic inhalable drug product is equivalent to an innovator drug product. Multi-stage cascade impactors are used to determine APSD, but analyzing the data is complicated due to multiple stages and non-size measurement components. Two topics have been controversially discussed: using APSD data to draw conclusions about efficacy and safety, and choosing a statistical methodology for equivalence testing. A stepwise cascade impactor equivalence test has been proposed, based on the population bioequivalence (PBE) test and the modified chi-square ratio statistic (mCSRS). This article aims to explain the proposed test, compare it with the average bioequivalence (ABE) test, and demonstrate its application using a practice data set. The data set consists of 60 NGI profiles from a hypothetical reference (REF) product and a test (TEST) product, and visual analysis and statistical tests are used to compare the APSD of the two products. The results show that the TEST and REF products differ on some stages, and the stepwise cascade impactor equivalence test is used to determine equivalence. The article also provides a user-friendly web application for applying the test to own NGI data.

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Objective methods for evaluating the equivalence of aerodynamic particle size distributions (APSD) are crucial for determining whether a generic inhalable drug...

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  • File Format: PDF
  • File Size: 874 KB
  • Pages: 7
  • Language: EN
  • Author: Benjamin Weber
  • Total Downloads: 204
  • Last Updated: 3 weeks ago

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