Table 4.

Estimated milk withdrawal intervals for lactating goats after single or multiple doses of flunixin meglumine administered intravenously or subcutaneously.

	EMA method	FDA method
Single IV administration at 1.1 mg/kg	34.1 h (36 h)	36 h
Single SC administration at 1.1 mg/kg	37.9 h (48 h)	36 h
Repeated IV administration at 1.1 mg/kg at 12-h intervals for 6 injections	NA	36 h
Repeated SC administration at 1.1 mg/kg at 12-h intervals for 6 injections*	51.5 h (60 h)	48 h

The EMA method refers to the computerized version of the method (i.e., WTM 1.4 software) used to calculate withdrawal periods for milk developed by the Committee for Veterinary Medicinal Products (CVMP) of European Medicines Agency (EMA). The FDA method refers to the tolerance limit method (coded in the “reschem” R package) used to calculate milk withdrawal interval times developed by US Food and Drug Administration (FDA). The EMA method outputs the exact time when the drug concentration is below the tolerance (i.e., the maximum residue limit), and this time should be rounded to the next milking interval (shown in parenthesis assuming a 12-h milking interval). NA indicates that the withdrawal time is not calculable due to missing values or high variability of the data.

^*Animal #8 in the repeated SC injection study was excluded because it was an apparent outlier.

Milk withdrawal intervals following extra-label drug use were estimated using EMA and FDA regulatory methods.