Duane Lakings - The Common Technical Document for the Registration of Pharmaceuticals for Human Use

Version 1

      Publication Details (including relevant citation   information):

      In New Drug Approval   Process, Fourth Edition, Accelerating Global   Registrations,  (Richard Guarino, editor).    Marcel Dekker, Inc., New York, NY, 2004, pp. 441‑488.

      Abstract:

      This chapter provides detailed information on the ICH Common   Technical Document (ICH M2 and M4) and the necessary information   to be included for the Quality, Safety, and Efficacy sections of   the CTD.

      Address (URL): http://