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.
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.
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