We manufacture clinically tested medicinal products. Bioequivalence studies are one of the essential milestones on the path from prototypes, created through research and development, to medicinal products suitable for use in treatments.

By measuring the blood concentration of active ingredients, these studies confirm the bioequivalence of Krka’s medicinal products with the reference medicinal products, thus proving their comparable efficacy and safety. The bioanalytical methods used in our state-of-the-art and automated bioanalytical laboratories can detect even the lowest active-ingredient concentrations in biological materials. We have been introducing less invasive modern microsampling techniques.

Based on these results, we acquire marketing authorisations for our medicinal products.

Krka is one of the few generic pharmaceutical companies that support post-authorisation clinical studies. These studies provide valuable insights into overall treatment – from disease diagnosis, correct choice of medicine and dosage, to the efficacy of our products.

Clinical studies supported by Krka significantly contribute to healthcare professionals making the right and reliable decisions in day-to-day patient care, as well as to treatment success and medical advances.

High ethical standards, valid guidelines and regulations underpin clinical studies performed with Krka’s medicines. This allows us to provide healthcare professionals and regulatory authorities with additional data on our medicines and a greater understanding of real-life clinical practice.

Krka strives to ensure that participants in our clinical studies represent the diverse patient populations who may use our medicines with regard to age, sex, ethnicity, and other relevant characteristics.

Krka is committed to responsible data sharing and transparency in clinical research, providing healthcare professionals and researchers with access to study results and relevant anonymized patient-level data to advance scientific knowledge and improve patient care.

We promote transparency in clinical research by making study results and information on the demographic distribution of participants publicly available. In selected studies, subgroup analyses are conducted to assess treatment outcomes across different demographic and clinical populations.