Guidance for Industry: Effectiveness of Anthelmintics: General Recommendations,VICH GL7. Final Guidance

摘要

Two sections have been identified in the guidance's general elements, andspecific 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.