Good practice in the use of veterinary

A definition of good practice in the use of veterinary drugs has also been adopted ... 

GOOD PRACTICE IN THE USE OF VETERINARY DRUGS (GPVD) is the officially recommended or authorised usage approved by national authorities, of veterinary drugs under practical conditions in a manner that leaves toxicologically acceptable residues of the smallest amounts practicable. 

With veterinary drugs, data on good practice in the use of veterinary drugs are evaluated and corresponding MRLs in animal tissues, milk, and/or eggs are recommended. Such MRLs are intended to provide assurance that when the drug has been used properly, the intake of residues of the drug present in food is unlikely to exceed the ADI. 

Specialists invited to serve as members of JECFA are independent scientists who serve in their individual capacities as experts and not as representatives of their governments or employers. They also understand that the discussions at the meetings are confidential. The goal is to establish acceptable daily intakes (ADIs) (or equivalent tolerable intakes) for food chemicals and to develop specifications for identity and purity for food additives or maximum residue limits (MRLs) when veterinary drugs are used in accordance with good practice in the use of veterinary drugs. 

In summary, when an ADI is established, consideration of the estimated intakes of the relevant foods by human beings allows an assessment to be made of a safe and acceptable residue level for the relevant animal tissue(s). If the levels of residues estimated from supervised trials, when the drug is administered according to good practices in the use of veterinary drugs (only the amount which is necessary to obtain the desired effect is used), are below those considered toxicologically acceptable, then the levels determined by good practice will dictate the acceptable residue level, provided that practical analytical methods are... 

Graphitized carbon black (GCB) has been reported to be a highly effective sorbent for sample clean-up but also removes structurally planar analytes, limiting its applications. Addition of HOAc to the extraction solvent may help to improve recovery of analytes, but it also inhibits the retention of acidic matrix compounds. Several papers have reported the use of Cl8 for dSPE in veterinary residue analysis. " The use of PSA, NH2, and silica has also been reported. While dSPE does not provide the same degree of clean-up as SPE, it does provide good recovery and reproducibility, coupled with practical and cost advantages. ... 

An example of the application of this procedure for testing the equivalence of the albendazole or ivermectin MRLs for which differences exist between the United States and JECFA is presented in Table 12.5. Differences between US and JECFA MRLs for albendazole are due to use of different safety factors and to the JECFA consideration of good veterinary practice. That is, JECFA considered practical conditions of use of the drug and set MRLs consistent with that use accordingly, the entire ADI is likely not to be consumed. On the other hand, the United States always uses the entire ADI in setting MRLs for edible tissues. 

Council of Europe (2005) European pharmacopeia, 5th edn. Maisonneuve, Paris European Economic Community (1997) Pharmaceutical legislation for medicinal products for human and veterinary use in the European Union. Good manufacturing practices. (Directive 91/ 356/EEC). Eudralex, vol. IV. European Economic Community, Luxemboiug European Economic Community (1998) Notice to applicants for marketing authorization for medicinal products for human use in the Eiuopean Union, Volume IIA (III/3567/92)... 

Although the hemoglobin Aic assay is by far the more estabhshed in clinics than the fructosamine assay, the latter may be a good alternative in cases when accuracy of the former is compromised, as in anemia. The content of D-fructosated serum proteins, such as albumin, transferrin, or IgG, correlates with the overall fructosamine content and their separate analysis may also be used for diagnostic purposes, in both cUnical and veterinary practices. 

Guidelines are meant to guide the implementation of legislation, as it is stated for instance Volume 4 contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/ EC, and 91/412/EEC respectively. ... 

The basic legislation is compiled in a series of guidelines that are published in Volume 2 till Volume 10. Volume 4 is about guidelines for good manufacturing practices for medicinal products for human and veterinary use, which is also known as European Good Manufacturing Practices (EU GMP). 

In contrast, the EU approach consists of computing a TMDI using MRL, not median residue concentrations CVMP criticized the JECFA approach for its intrinsic limitation to a chronic risk scenario and also for several technical reasons, including difficulties of using linear regression to estimate the tolerance limit of residue concentrations with its confidence interval and to the rather loose concept of good veterinary practice. (For further details, see Ref. 106. For further details on and a discussion of the USFDA approach, see Refs. 105 and 108.)... 

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