Executive summary: scientific and regulatory challenges of development of probiotics as foods and drugs.
Hoffman
Freddie Ann
FA
HeteroGeneity, Washington, DC 20011, USA. fhoffman@heterogeneity-LLC.com
Heimbach
James T
JT
Sanders
Mary Ellen
ME
Hibberd
Patricia L
PL
D035843:Biomedical Research / Q000592:standards; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety; D004345:Drug Industry / Q000592:standards*; D019649:Food Industry / Q000592:standards*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D019936:Probiotics / Q000592:standards* / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration