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BookletJECFA Toolbox for Veterinary Drug Residues Risk Assessment
Section 4.1. JECFA’s approach for assessing dietary exposure to veterinary drug residues: Estimating total residues for use in dietary exposure assessment
2024By this point, you will understand the roles of both the total residue and marker residue depletion studies. Consult the guidance document to: • review how the M:T ratios are calculated in edible tissues at any time point after drug administration; and• see how total residue estimates are calculated based on the marker residue depletion and M:T data. This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs. -
BookletJECFA Toolbox for Veterinary Drug Residues Risk Assessment
Section 2. Hazard assessment: How health-based guidance values are derived and used in the JECFA drug residue risk assessment
2024Specific types of toxicological and microbiological data are essential for performing a robust hazard assessment of veterinary drug residues. The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and other agencies provide guidance on the design and analysis of such studies. Consult the guidance document on hazard assessment to learn how JECFA identifies key study outcomes and subsequently derives relevant HBGVs, including the following processes:• Toxicological studies: Determining the no observable adverse effect level (NOAEL) from toxicological studies and selecting an appropriate uncertainty (safety) factor (UF);• Microbiological studies: How minimum inhibitory concentration (MIC) data can be used to assess relevant microbiological endpoints, such as disruption of the colonization barrier in the human colon and emergence of antimicrobial resistance; • Derivation of both chronic (acceptable daily intake) and acute (acute reference dose) health-based guidance values, and the difference between these HBGVs.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs. -
BookletJECFA Toolbox for Veterinary Drug Residues Risk Assessment
Section 3.4. Estimating median and tolerance limit values for marker residues
2024To estimate human dietary exposure to veterinary drug residues and establish maximum residue limits (MRLs), derivation of median residue concentration and upper tolerance limit (UTL) is necessary. The first value represents a typical residue concentration for the entire dataset of concentrations measured in samples (e.g. tissue, milk, eggs) from individual animals over a range of time periods. UTL values are calculated to consider those samples in which marker residues are present at concentrations higher than average levels, potentially posing a higher risk to consumers.Consult the guidance document on median and tolerance limit values for marker residues to: • plot the residue concentrations graphically and determine the median residue concentrations in edible tissues at any time point after drug administration, using the hypothetical data set provided; • learn about the concept of UTL residues (95/95 UTL, the upper limit of the one-sided 95% confidence interval over the 95th percentile of marker residue concentrations); and• see how the design of the marker residue depletion study influences the resulting 95/95 UTL, with subsequent impacts on the derivation of maximum residue levels.This publication is part of the FAO JECFA Toolbox for Veterinary Drug Residue Risk Assessment. The toolbox provides practical guidance on the principles, modalities and technical requirements of JECFA in assessing the risks of veterinary drug residues in food and in recommending MRLs.
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