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Intra-mammary antibiotics are widely used, and are an important contributor to the control of bovine mastitis. The concentrations of antibiotic drugs in milk after intra-mammary administration is highly important for food protection and treatment efficacy. In this project, novel mathematical and statistical models were developed to describe the pharmacokinetics of antibiotic drugs after intra-mammary administration. This approach combined physiologically-based pharmacokinetic models to capture the unique features of the mammary gland, and large-scale mixed-effects analysis to understand these effects at the level of the treated population. The developed models perform well across various drug types and production conditions, and it is proposed that these models are suitable as a generalized method for the description and analysis of drug concentration in milk. Further, the developed methods are applied to study the statistical performance of the various existing methods used to study milk residues in the regulatory context. A derived model is discussed, which is suitable for application to regulatory conditions for the determination of milk discard times.