In vitro‐in vivo correlation (IVIVC) allows prediction of the in vivo performance of a pharmaceutical product based on its in vitro drug release profiles and can be used to reduce the number of bioequivalence (BE) studies during product development, and facilitate certain regulatory decisions. Here, we developed an IVIVC model for pitavastatin calcium, a basic Biopharmaceutics Classification System (BCS) II lipid‐lowering drug, which was then used to predict the BE outcome of formulations manufactured at two manufacturers. In addition, virtual trials using the IVIVC model using pH 4.0 acetate buffer dissolution showed similarity in areas under the curves and maximum plasma concentration (Cmax) for test and reference tablets under fasting condition. These predicted results were verified in definitive BE study. In conclusion, we demonstrated that for certain BCS II molecules, IVIVC modeling could be used as a priori to predict the BE outcome.

Ciprofol (also known as HSK3486) is a promising intravenous anesthetic candidate derived from propofol and independently developed by Haisco Pharmaceutical Group Co., Ltd. (Chengdu, China). Compared with propofol, ciprofol has the potential to reduce the dose required and the associated risks. Ciprofol is extensively metabolized in vivo, and its interaction with other concurrently administered drugs during clinical application is worthy of attention. Therefore, an open‐label, two‐stage sequential study was performed in healthy subjects who received either a single administration of ciprofol injection or ciprofol injection after oral administration of sodium divalproex. The aim of the study was to evaluate the effects of sodium divalproex on ciprofol with respect to pharmacokinetics, pharmacodynamics, and safety, thus providing a basis for the rational clinical use of ciprofol and sodium divalproex.