GLP-GMP Regulatory Compliant Research

Sporometrics was pleased to partner with a veterinary contract research and consultant company, to design and conduct GLP-GMP regulatory compliant research for drug approval in the veterinary pharmaceutical industry. Household cats are prone to ringworm infection which is caused by the dermatophyte fungi Microsporum canis and it is estimated that 1.3 million cats (based on disease incidence from itraconazole Research, Market Vibes, 2013) are treated for ringworm each year. Current treatment involves a topical antifungal cream containing itraconazol however due to cat behavior, creams can be licked off or washed off delaying treatment. It was unknown if oral treatment of itraconazole would provide the same efficacy for this common issue. From conception of a small scale pilot study to leading the full scale clinical trial, Sporometrics provided the pivotal mycological studies to illustrate the effectiveness of the antifungal drug. This strong collaborative effort between the two labs lead to the successful approval by the Center for Veterinary Medicine (CVM) for this new application to hit the veterinary market.