The recommended (minimum) monthly dose rate of lotilaner is 20 mg/kg. Since the tablets are recommended for a weight band, the dose rate range is 20-43 mg/kg to be administered once a month orally. Methods This randomized, controlled, blinded study was conducted with reference to the guidelines for evaluating the target animal safety of new pharmaceuticals [VICH Guideline 43, and to recognized quality assurance standards (United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations, 21 Code of Federal Regulations (CFR) Part 58 and the Organization for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 13)] [8-10]. The clinical chemistry profile included: alkaline phosphatase, total bilirubin (with direct bilirubin if total bilirubin exceeds 1 mg/dl), aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, urea nitrogen, creatinine, total protein, albumin, globulin and albumin/globulin ratio (calculated), glucose, total cholesterol, triglycerides, electrolytes (potassium, chloride, sodium) calcium, and phosphorus. Ethics approval The study was based on the guidelines for evaluating the target animal safety of new pharmaceuticals [VICH Guideline 43, and to recognized quality assurance standards (United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations, 21 Code of Federal Regulations (CFR) Part 58 and the Organization for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 13)].