Methods to estimate safety and/or efficacy of therapeutic drugs, which include portable devices for anti-drug antibody (ADA) testing and databases containing anonymized data from humans and/or animal models, and related analyses, are provided. These methods and compositions can be used in various applications, including but not restricted to the following: uniform testing of patients for ADA； selection of therapeutic drug for patient treatment； evaluation of the need to change therapeutic drug or to apply tolerance regimens； selection of patients for clinical trials； comparison of therapeutic drugs marketed for a given disease and also gene therapy； scientific guidance for discovering and/or developing therapeutic drugs； postmarketing surveillance of therapeutic drugs.
