for more details contact [email protected] content of this course will assist pharmaceutical, biotechnology, and CROresearchers and managers in understanding the requirements for a well-designed andsuccessful ADME, PK/TK, and DM program that is conducted within a drugdevelopment logic plan and in compliance ICH guidelines. The various types of ADME,PK/TK, and DM studies, which include in vitro metabolism and delivery, animal andhuman pharmacokinetics, protein binding, mass balance, tissue distribution, metaboliteisolation and identification, and toxicokinetic support, will be discussed. Study designsand potential results, with possible interpretations, from each of the study types will bepresented. The generation study reports and summaries, both of which are to be includedin submissions to regulatory authorities, for completed research experiments will bedelineated.