Pharmacometrics StudiesPharmacometrics StudiesPharmacometrics Studies relies on modeling and simulation technology to conduct quantitative research on pharmacokinetics (PK). This service covers core fields such as optimization of clinical trial protocols, population pharmacokinetics/pharmacodynamics analysis, physiological pharmacokinetic modeling, and selection of clinical endpoints. It realizes individualized drug guidance by integrating patient, drug, and disease data. Keplasentan hydrochloride tablets are a new type 1 drug independently developed by CophiPharm (formerly known as Conorazan hydrochloride tablets, H008). It has been officially approved for marketing. This innovative drug is a potassium-competitive acid blocker (P-CAB) and is used for the treatment of duodenal ulcers and reflux esophagitis. Through a clinical pharmacometrics model, we reasonably predicted the possible clinically recommended dose for the Phase III clinical trial of Keplasentan. As a result, in November 2019, it obtained the official approval from the National Center for Drug Evaluation to "exempt Phase II clinical trials and directly enter Phase III trials." It became the world's first DPP-IV inhibitor to exempt Phase II clinical trials and directly conduct Phase III confirmatory trials through a pharmacometrics model, attracting high attention from experts in the field of diabetes at home and abroad. |