title: Guest editors' note: special issue on recent developments in statistical approaches for chemistry and manufacturing control (CMC) and quality-by-design(QbD).
authors.affiliation: a Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Yi
authors.initials: Y
authors.lastname: Tsong
authors.forename: Harry
authors.initials: H
authors.lastname: Yang
mesh_terms: D000818:Animals; D001702:Biopharmaceutics / Q000592:standards / Q000706:statistics & numerical data*; D002626:Chemistry, Pharmaceutical; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D006801:Humans; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data*
chemical_list: D004364:Pharmaceutical Preparations