Jianmei D Kochling

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A platform analytical quality by design approach for methods development is presented in this paper. This approach is not limited just to method development following the same logical Analytical quality by design (AQbD) process, it is also exploited across a range of applications in methods development with commonality in equipment and procedures. As(More)
VX-497 is a poorly water-soluble compound. It is formulated in PEG-400 and encapsulated in softgel capsules. Although the drug product is stable at refrigerated conditions, many degradation peaks have been observed at accelerated storage conditions. An investigation utilizing high performance liquid chromatography-mass spectrometry (HPLC-MS) was conducted(More)
The selection of media in dissolution method development can sometimes be an arbitrary decision. The case studies in this article give a practical rationale that should help in selecting media, especially surfactants. Three cases were studied: (1) the role of surfactants versus compound stability in the dissolution medium during dissolution method(More)
There has been significant growth in the use of modeling tools to accelerate development and enhance pharmaceutical quality. Among these are empirical and semi-empirical modeling of accelerated stability studies which can be used to predict product shelf-life (Waterman, Pharm Res 24:780–790, 2007; (Wu et al., AAPS Pharm Sci Tech,16:986–991, 2016); (Lavrich,(More)
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