Introduction.- Written Communication in Drug Development.- Written Communication in Academic Settings.- Language Pitfalls: Native English Speakers.- Language Pitfalls: Non-Native English Speakers.- Scientific Misconduct.- Key Statistical Concepts.- Tables and Graphs.- International Conference on Harmonization (ICH) and Other Guidelines.- The Investigators' Brochure.- Initiating Clinical Programs (IND & IMPD).- The CTD: Overviews and Summary...