Detecting safety signals among adverse events in clinical trials

Scott Patterson, Byron Jones,L Aarons, M Karlsson,F Mentre,F Rombout,J-L Steimer,A van Peer, S Abdel-Rahman, M Reed, T Wells, G Kearns,G Agnelli,P Prandoni,C Becattini,M Silingardi, M Taliani,M Miccio,D Imberti,R Poggio,W Ageno,E Pogliani,F Porro,P Zonzin,G Ahr, B Voith,J Kuhlmann, H Akaike, M Akritas, M Bershady, J Albert, J Ioannidid,P Reichelderfer, B Conway,R Coombs, L Crane,R DeMasi, D Dixon,P Flandre, M Hughes, L Kalish, K Larntz,D Lin,I Marschner, A Munoz, J Murray,J Neaton,C Pettinelli, W Rida, J Taylor,S Welles, K Alberti,P Zimmet, J Shaw, M Ali, E Talukder, S Al-Marzouki, I Roberts, T Marshall, S Evans, A Alonso, G Molenberghs,HS Al-Sallami, VVP Kumar,CB Landersdorfer,JB Bulitta, SB Duffull, DG Altman, JM Bland, DG Altman,JM Bland, A Amankwa, S Krishnan, J Tisdale, J Amoros, KC Anderson, R Pazdur, AT Farrell, S Anderson, WW Hauck, S Anderson,WW Hauck, S Anderson,WW Hauck, Y Ando, Y Uyama, R Ansbacher, E Antman, N Aoyagi, M Aregay,Z Shkedy,G Molenberghs, M-P David,F Tibaldi, A Atkinson, C Daniels,R Dedrick, C Grudzinskas, S Markey, A Atkinson, R Lalonde, K Aurenen,E Arjas, T Leino,A Takala, A Awad, S Baker, N Balakrishnan, CW Ma, JP Balthasar, H Bang, S Jung, S George, MM Barbieri,B Liseo,L Petrella, JS Barrett,V Batra,A Chow, J Cook, AL Gould, A Heller,M-W Lo, SD Patterson, BP Smith, JA Stritar, JM Vega,N Zariffa, F Barthel, A Babiker, P Royston, M Parmar, MS Bartlett, RP Basson, A Ghosh, BJ Cerimele, KA DeSante, DC Howey,S Bate, B Jones, H Bauchner, P Bauer, MM Bauer, P Bauer, M Kieser, P Bauer

Bioequivalence and Statistics in Clinical Pharmacology(2017)

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Abstract
Many people in business and medicine regard statistics as at best a nuisance, or as a challenging (frequently incomprehensible) and therefore best ignored subject (whenever possible), or at worst as an hinderance to science. Even Einstein liked to say that “God doesn’t gamble.” .
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