Estimating Provisional Acceptable Residues for Extralabel Drug Use in Livestock

Baynes, Ronald E.; Martı́n-Jiménez, Tomás; Craigmill, Arthur L.; Riviere, Jim E.

doi:10.1006/rtph.1999.1302

Cited by 28 publications

(12 citation statements)

References 16 publications

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“…If we assume that the concentration of 0.01 mg/L is the maximum allowed level of residues of florfenicol in milk according to suggestions of Baynes et al (17) withdrawal-time after intramuscular treatment, should be probably 6.77 days and for the intramammary treatment 2.8 days. These withdrawal-times could be lower if a greater level of tolerance of 0.10 mg/L is established.…”

Section: Discussionmentioning

confidence: 99%

“…For estimating the Admissible Daily Intake (ADI) a safety factor of 100 was used, which determined an ADI of 0.01 mg/Kg or 0.6 mg/person of 60 Kg of weight in average (16), or Theoretical Maximum Daily Intake (TMDI) (17). The TMDI divided by the consumption factor of the different animal tissues determines the Tol (Tolerance Levels) for the United States, and Maximum Residues Level (MRL) outside the United States (18).…”

Section: Introductionmentioning

confidence: 99%

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Florfenicol concentrations in milk of lactating cows postreated by intramuscular or intramammary routes

et al. 2010

Rev MVZ Córdoba

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Concentraciones de florfenicol en leche de vacas en lactancia postratamiento por vía intramuscular o intramamariaJohn Ruiz B, ABSTRACTObjective. To determine the florfenicol concentration in bovine milk after intramuscular or intramammary administration to establish the optimum withdrawal time, therapeutic efficacy, and its influence on milk yield. Materials and method. Twelve healthy lactating Holstein cows were selected from the University of Antioquia's teaching dairy herd (Colombia), were randomly assigned to a control (n=6) group or florfenicol (n=6) group that received 20 mg/kg of florfenicol by intramammary and intramuscular routes, with a 15 days washout period between treatments. Results. The Tmax and Cmax for the intramuscular route were 6 hours and 2.86 mg/L respectively. The Tmax and Cmax for the intramammary route, were estimated at 0 hour and about 20000 mg/L respectively by extrapolated from regression line. The florfenicol elimination phase in milk had an average half-life of elimination (t½) of 19.8 hours and 4.9 hours for intramuscular and intramammary administration, respectively. The therapeutic efficacy only was reached by intramammary route, when minimal inhibitory concentration (M.I.C.) of florfenicol by Stahphylococcus aureus, was used as reference value. There was no statistically significant difference in milk yield between treated and non-treated cows. Conclusions. According to these results, post-treatment milk withdrawal should be no less than 3 days for intramammary administration, and at least 7 days for intramuscular administration. The therapeutic efficacy only was reached by intramammary route. In addition, there was no statistically significant difference in milk yield between treated and nontreated cows. RESUMENObjetivo. Determinar la concentración de florfenicol en leche bovina después del tratamiento intramuscular o intramamario, para establecer el tiempo de retiro, la eficacia terapéutica, y su influencia sobre la producción láctea. Materiales y métodos. Se seleccionaron doce vacas Holstein en lactancia de la hacienda de Universidad de Antioquia (Colombia). Se asignaron al azar al grupo control (n=6) o al grupo florfenicol (n=6), al cual se le administró 20 mg/kg de florfenicol por vía intramamaria e intramuscular con 15 días de diferencia entre tratamientos. Resultados. La Tmax y Cmax para la vía intramuscular fueron 6 horas y 2.86 mg/L respectivamente. La Tmax y Cmax para la vía intramamaria, fueron estimados como 0 hora y aproximadamente 20000 mg/L respectivamente por extrapolación de la línea de regresión. La fase de eliminación del florfenicol en leche, tuvo una vida media de eliminación (t½) promedio de 19.8 horas y 4.9 horas para la vía intramuscular e intramamaria respectivamente. Cuando la concentración inhibitoria minima (C.I.M) del florfenicol para Stahphylococcus aureus, fue usada como el valor de referencia, la eficacia terapéutica sólo se alcanzó por la vía intramamaria. No existió diferencia estadística significativa entre las producciones lácteas de las v...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Florfenicol concentrations in milk of lactating cows postreated by intramuscular or intramammary routes

et al. 2010

Rev MVZ Córdoba

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“…This milk concentration is equivalent to a safe concentration or a provisional acceptable residue for ivermectin in milk recently described in the literature. 13 Based on these data and assumptions, a milk WDI of 53 days would be a conservative estimate for dairy cattle exposed to ivermectin pour-on.…”

Section: Extralabel Use Of Ivermectinmentioning

confidence: 99%

Extralabel use of ivermectin and moxidectin in food animals

Baynes

Payne

Martı́n-Jiménez

et al. 2000

javma

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“…Recently, Baynes et al 45 published a method for establishing provisional acceptable residue concentrations of drugs and contaminants in food animal products. This method can be used to establish target concentrations for residue depletion based on tolerances, MRLs, and ADIs, using all available data.…”

Section: Food Safety Considerationsmentioning

confidence: 99%

“…The ADI for a veterinary drug is often apportioned to various tissues and products to ensure that ingestion will be less than the ADI. 45 When making extralabel withdrawal interval estimations, the FARAD method assumes that a safe tolerance in a minor species will be the same as that in the major species for which the drug is approved. This assumption is based on the belief that the minor species food product would be ingested instead of the major species food product.…”

Section: Food Safety Considerationsmentioning

confidence: 99%

Interspecies considerations in the evaluation of human food safety for veterinary drugs

Craigmill

Cortright

2002

AAPS J

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Residues are composed of the parent drug and metabolites, and therefore interspecies comparisons must involve a consideration of comparative xenobiotic metabolism. The focus of this article will be the residue studies that are required to establish human food safety, and the interspecies pharmacokinetic differences and similarities that impact drug residues in animal-derived foods. To illustrate the factors that can complicate and assist these comparisons, 2 drugs will be examined in detail: ivermectin and fenbendazole. In addition, the activities of 2 US programs, the Food Animal Residue Avoidance Databank (FARAD) and the NRSP-7 (National Research Support Project Number 7) Minor Use Animal Drug Program will be presented, along with strategies that may be employed in the study of species differences.

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Estimating Provisional Acceptable Residues for Extralabel Drug Use in Livestock

Cited by 28 publications

References 16 publications

Florfenicol concentrations in milk of lactating cows postreated by intramuscular or intramammary routes

Florfenicol concentrations in milk of lactating cows postreated by intramuscular or intramammary routes

Extralabel use of ivermectin and moxidectin in food animals

Interspecies considerations in the evaluation of human food safety for veterinary drugs

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