human food safety of new animal drugs microbial …:新型动物药品的人类食品安全….pptxVIP

human food safety of new animal drugs microbial …:新型动物药品的人类食品安全….pptx

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1;FDA/CVM;Any compound present in the edible tissues after treatment with the new animal drug. Includes parent drug, metabolites, and any substance formed in or on food. The definition is broad enough to include resistant bacteria. ;Human Food Safety Assessment;Assess the Microbial Food Safety of New Animal Drugs in the following categories: Antimicrobial resistance development in drugs of human concern Potential disruption and/or development of antimicrobial resistance in the human intestinal bacteria ; Risk = Hazard x Exposure;Using a Qualitative risk assessment approach Assess antimicrobial drugs intended for food-producing animals regarding the development of antimicrobial resistance Address human exposure to antimicrobial resistant microbes through ingestion of animal-derived food ;;The hazard has been defined as human illness caused by an antimicrobial-resistant bacterium attributable to an animal-derived food commodity treated with a human antimicrobial drug of concern. In some instances, a hazard characterization is sufficient for a particular antimicrobial drug;Describes factors related to an antimicrobial drug and its use in animals that contribute to the emergence of antimicrobial resistant bacteria or antimicrobial resistance determinants in the animal;Mechanism of Activity Spectrum of Activity Pharmacokinetics Pharmacodynamics Antimicrobial Resistance Mechanism Antimicrobial Resistance Transfer Selection Pressure ;Hazard: Emergence of Antimicrobial Resistance Parameters: Mechanism of Activity – Class of Drug, targeted action Spectrum of Actvity – Gram +/- activity, susceptibility data Antimicrobial Resistance mechanisms – Structural, efflux, gene Antimicrobial Resistance Transfer – chromosomal, mobile element Selection Pressure – co-selection ;Describes likelihood of human exposure to food-borne bacteria of human health concern through animal-derived food products ;Probability that humans consuming animal derived foods will be exposed to resistant

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