In this white paper, we show testing of two critical parameters for the method validation of Gyrolab: 1) carryover contamination and 2) after MRD (minimum required dilution) stability.
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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 the skin to provide pain relief, and used to numb an area before placing an IV, drawing blood, or giving injections. A typical stability study is conducted by the assay of API in the drug product, but the different product qualities may affect penetration. To evaluate penetration, in vitro human cadaver skin model using Franz diffusion cells is used to determine product equivalence. In this study, we evaluate the product equivalence at different stability time points between RLD and test products.
In this study, we develop an LC-MS/MS assay for quantifying Azacitidine in Human Plasma and apply this method to support a phase ½ clinical study on the efficacy of Azacitidine in cancer subjects.
Assessing a compound’s stability is a complex and lengthy process with objectives varying by the development phase. A poorly designed stability study can cause delays that extend to years, create significant budget overruns, and even result in product failure. Thus, stability testing requires scientific expertise and very specialized experience to minimize development costs and avoid severe consequences. This webinar discusses the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.