Surrogate matrix has been widely used in bioanalysis, especially for endogenous compounds analysis. Surrogate analyte approaches, on the other hand, are only occasionally employed in bioanalysis, but play a significant role and serve as a useful tool for the quantitation of various analytes, ranging from small molecular biomarkers to large molecule biological entities. This webinar will give a brief review of the surrogate analyte approaches during bioanalysis using LC-MS platform, from both scientific and regulatory perspectives. A few case studies will be discussed in detail laying out the challenges, and approaches to tackle these challenges.
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In this case study, Frontage successfully completes the method development and validation under the Sponsor's pressing timelines, while providing high quality, and reproducible data with an ISR passing rate of over 90%.
In this case study, we share how Frontage used Gyrolab to conduct a Sponsor's study efficiently saving precious sample volumes.
EMLA Cream (lidocaine 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine. It is a numbing cream that can be placed on skin to provide pain relief. It is often used to numb an area before placing an IV, drawing blood, or giving injections.
Typical stability study is conducted by the assay of active pharmaceutical ingredient (API) in the drug product. However, the assay results may not indicate drug product’s penetration rate similarity between different products over a certain period of time frame because of the differences in its topical product qualities (such as rheology, particle size, excipients, penetration enhancers, etc.). Therefore, it is important to evaluate the penetration of compounds into human skin during drug product stability study.
In vitro human cadaver skin model using Franz diffusion cells (invented in 1975) is widely regarded as the most valid in vitro model for evaluating the penetration of compounds into human skin. It can be used to determine the product equivalence.