title: Determination of sulfadimethoxine withdrawal time from milk. Part II: Statistical assessment.
abstract: A statistical method is proposed to establish milk discard time for the data set described in Part I (preceding paper). Results are compared with those from the Food and Drug Administration (FDA)-recommended method. The milk discard time is established on the basis of a calculated tolerance limit. This limit provides 95% confidence that 99% of the population residue would assay below the permitted concentration (10 ppb for SDM). Unlike the FDA method, the proposed method allows easy calculation and requires no assumptions in drug depletion rate over time. For a permitted concentration of 10 ppb, both methods confirm the present 60-h discard time for SDM when it is assumed that no more than 1/3 of the milk came from treated cows.
authors.affiliation: Hoffmann-La Roche, Inc., Nutley, NJ 07110, USA.
authors.forename: E L
authors.initials: EL
authors.lastname: Lentz
authors.forename: J
authors.initials: J
authors.lastname: Chung
mesh_terms: D000818:Animals; D002417:Cattle; D004350:Drug Residues / Q000032:analysis*; D005260:Female; D008452:Maximum Allowable Concentration; D008892:Milk / Q000737:chemistry*; D013223:Statistics as Topic / Q000379:methods; D013412:Sulfadimethoxine / Q000008:administration & dosage / Q000032:analysis* / Q000493:pharmacokinetics; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D013412:Sulfadimethoxine