Clinical trials of medicinal products..

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The dominant part of clinical trials conducted by BioStat® is research on the introduction of new drugs to the market. We help pharmaceutical and biotechnology clients in the process of searching for new, more effective drugs, but also in the evaluation of existing drugs, the therapeutic value of which is not fully known.

A medicinal product commonly known as a drug, is a substance or mixture of substances with the properties of preventing or treating specific disease entities.

Before a drug becomes widely used, it must go through a process of preclinical and clinical trials. In Poland, a marketing authorization is issued by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

There are two types of medicinal products: an innovative drug (also known as the reference drug) and a generic drug, which is a replacement for an innovative product.

Phases of clinical trials:
Phase I
initial assessment of the drug's safety and pharmacological properties, a group of several dozen healthy volunteers, positive results enable the transition to phase II.
Phase II
determining the dose, preliminary analysis of the safety and efficacy of the drug, a group of several hundred patients with a specific type of disease, positive results enable the transition to phase III.
Phase III
confirmation of the effectiveness and safety of the drug, a group of several thousand patients. positive results allow the drug to be registered and introduced to the market.
Phase IV
studies of registered and marketed drugs, confirmation of long-term efficacy and safety of the drug, new indications for an already registered drug are also tested.

We conduct single- and multi-center research in Poland and abroad. Therapeutic areas in which we have so far conducted clinical trials for medicinal products include:

Oncology Ophthalmology Dermatology Psychiatry Allergology Invasive cardiology Neurology

During the research, we mainly work in the model Sponsor - CRO - BioStat®, being responsible for:

Badania kliniczne COVID-19
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