2015
DOI: 10.1016/j.yrtph.2015.02.013
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Tissue concentrations of sulfamethazine and tetracycline hydrochloride of swine ( Sus scrofa domestica ) as it relates to withdrawal methods for international export

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Cited by 7 publications
(3 citation statements)
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References 14 publications
(17 reference statements)
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“…Extra-label drug use (ELDU) refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. It occurs when a drug only approved for human use is used in animals when a drug approved for one species of animal is used in another, when a drug is used to treat a condition for which it was not approved, or the use of drugs at levels in excess of recommended doses [12]. For instance, the use of enrofoxacin solution as a topical ear medication (only approved for use as an injection) is the common ELDU in veterinary medicine [13].…”
Section: Extra-label Drugmentioning
confidence: 99%
“…Extra-label drug use (ELDU) refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. It occurs when a drug only approved for human use is used in animals when a drug approved for one species of animal is used in another, when a drug is used to treat a condition for which it was not approved, or the use of drugs at levels in excess of recommended doses [12]. For instance, the use of enrofoxacin solution as a topical ear medication (only approved for use as an injection) is the common ELDU in veterinary medicine [13].…”
Section: Extra-label Drugmentioning
confidence: 99%
“…In addition, different approaches, many based on statistics, have been used to determine the withdrawal time for veterinary drugs in foodproducing animals. These include the use of half-life multipliers (number of half-lives contained within the withdrawal time), the withdrawal-period estimator algorithm [30,31], the non-parametric methods for specific drugs [32], and the physiologically based pharmacokinetic modeling [33][34][35][36]. The statistical linear regression method is the most widely used and recommended by both FDA (at 99% of tolerance interval with 95% confidence intervals) and EU (at 95% tolerance with 95% confidence intervals), although it was not considered the best approach [37].…”
Section: Lack Of Global Harmonization: Mrls/tolerances and Withdrawal Periodsmentioning
confidence: 99%
“…These singularities, related to the different MRLs, procedures for calculating WP, and drug tissue residue data considered, have been demonstrated. When Udiani et al [38] estimated the WP for veterinary drugs, such as sulfamethazine in swine liver [35] and flunixin in calf liver [26], different values were obtained depending on the data and the MRL taken into account. In the same way, tissue residue levels of florfenicol and tylosin in different tissues were considered to determine the WP by the linear regression method with both recommendations (FDA and EU), and different values were obtained [39].…”
Section: Lack Of Global Harmonization: Mrls/tolerances and Withdrawal Periodsmentioning
confidence: 99%