Simcyp Simulator 影响了超过 80 种新药的开发
250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.” This is the language typically used by the US FDA on drug labels to describe how clinical pharmacology decisions have been reached. Much more detail can be found in the Office of Clinical Pharmacology (OCP) review that supports … Continued
