Statistical Issues in Biologics Submissions to the FDA. Lynch, C. J. & Lachenbruch, P. A. Drug Info J, 30:921-932, 1996.
doi  bibtex   
@article{lyn96sta,
  title = {Statistical Issues in Biologics Submissions to the {{FDA}}},
  volume = {30},
  journal = {Drug Info J},
  doi = {10.1177/009286159603000408},
  author = {Lynch, Cornelius J. and Lachenbruch, Peter A.},
  year = {1996},
  keywords = {teaching-mds,rct,study-design,reporting,clinical-trials,checklist},
  pages = {921-932},
  citeulike-article-id = {13264552},
  citeulike-linkout-0 = {http://dx.doi.org/10.1177/009286159603000408},
  posted-at = {2014-07-14 14:09:37},
  priority = {0},
  annote = {checklist for design and reporting of pharmaceutical studies}
}

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