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The complex nature of studies contributing to the reputation of Krkaʼs veterinary medicines
Ščuka, Leon ; Kužner, Jernej ; Miklič, Špela
Krkaʼs Animal Health Programme offers modern, effective and safe products that are the result of our own know-how and years of experience in the area of veterinary care. Many in vivo studies in the ...recearch and development of veterinary medicines are performed to fulfil the regulatory requirements for providing evidence of their safety and efficacy. All in vivo studies are performed in compliance with animal welfare regulations, good laboratory and clinical practices and study-specific guidance. From the safety point of view,the following two general requirements have to be adequately addressed by in vivo studies: human (consumer) safety if the medicinal product is intended for use in food-producing animal species (residue studies), and the safety of the animal species intended to be treated (local and systemic tolerability studies). From the efficacy point of view, all claims have to be based on the findings from in vivo efficacy studies. However, Krka also employs several techniques to justifiably substitute in vivo studies for in vitro studies, or scientifically based justifications. The present overview of in vivo studies will demonstrate the great variety of study designs employed by Krka and shed some light on Krkaʼs approaches to them. With this article we would like to present some of the recently performed in vivo studies that were approved by the regulatory authorities and are the foundation of the claims in the Summary of Product Characteristics (SmPC) for Krkaʼs products. Krkaʼs experts also perform meta-analyses to review and combine the results of the studies. They provide an upgrade option for discovering and exploring data in the existing scientific literature and can yield plausible explanations or even result in the discovery of new knowledge.They can also give practical answers to controversial clinical issues and save costs of additional clinical experiments.
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