This guidance is intended to standardize and simplify methods used in the evaluation of new anthelmintics submitted for approval to the European Union, Japan, and the United States.

Two sections have been identified in the guidance’s general elements, and specific evaluation studies. The General Elements section includes: good clinical practice, evaluation of effectiveness data, types of infection and parasite strains, product equivalence, recommendations for the calculation of effectiveness, standards of effectiveness and the definition of helminth claims. The Specific Evaluation Studies section describes dose determination, dose confirmation, field and persistent effectiveness studies.

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