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    Primum non nocere – a word about wise use of medicines and reporting adverse drug reactions

    28 marca 2024

    Since the prehistoric times people have used medications, primary in form of medicinal plants. Palaeolithic humans built on and expanded their knowledge on active substances present in herbal plants [1]. Just as knowledge about possible treatments has evolved over time, so has increased the awareness of drug safety and possible adverse drug reactions that might […]

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    How to divide responsibilities in a GMP-related contract? A quality agreement is the answer

    18 marca 2024

    For any company operating in the pharmaceutical sector and involved in manufacturing and/ or importing human and veterinary medicines, the Good Manufacturing Practice (GMP) is the closest thing to a holy book in the industry. It ensures that products are consistently produced and controlled according to quality standards, minimizing the risks involved in any pharmaceutical […]

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    Women Participation in Clinical Trials – Conflict, Controversy and Change.

    06 marca 2024

    Routinely, drug development studies are conducted using animals and in clinical trials with the participation of human beings. Both of them include two subgroups: the male and female. It is known that there are many differences between the two entities in several aspects including genes, hormones, anatomy, physiology, the interactions between the genes and the […]

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    A Brief History of the GMP

    20 lutego 2024

    Nowadays in the pharmaceutical industry the rules of Good Manufacturing Practice are something obvious. Quality manufacturing systems and the safety of the medicines are a priority for drug product manufacturers. However, it should be stated that the beginnings of GMP were developed on a number of tragedies.   How the FDA pioneered the development of […]

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    The changing face of clinical trials. A long and fascinating journey to effective and safe medicines.

    05 stycznia 2024

    In the era of numerous civilization diseases and other threats to human life and health, patients worldwide expect new therapies which are both effective and safe. However, access to modern drugs would not be possible without clinical trials, which are a necessary element of the drug marketing authorization process. Clinical trials have been a part […]

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    QPPV – the key player in Pharmacovigilance

    25 października 2023

    QPPV – this mysterious abbreviation identifies the most crucial person involved in the whole process of monitoring of safety of drug products, that is pharmacovigilance. The Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for the creation and management of the whole system ensuring the safe use of medicinal products both in humans and animals. […]

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    A white mouse is sitting on a cultural medium. Laboratory test tubes in the background.
    Replace, Reduce, Refine. Animal testing in drug development.

    16 października 2023

    In order to introduce a new medicine to the market, the applicant must demonstrate that the proposed product is safe and effective. This is done by presenting the set of quality, non-clinical and clinical data obtained during the developmental studies, which are then evaluated by regulatory authorities. The volume of the data required, impacting the […]

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    Post-covid syndrome
    From crisis to hope. Restoring mental wellness in a post-pandemic world

    09 października 2023

    The catalysts for deterioration: mental health puzzles The events of recent years have left a deep mark on our psyche. The safety measures taken to stop the pandemic in the years 2020-2021 have had a significant impact on our lives. Society had to confront lifestyle changes, uncertainty about the future, conflicts, domestic violence, and relationship […]

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    Medicinal products advertisement – what is it and what requirements must it fulfill?

    02 sierpnia 2023

    Nowadays it is difficult to imagine an economic entity functioning without using any form of advertisement. What about medicinal products? Do life-saving and life-enhancing products also need advertising? Do medicines which have pervaded our daily lives need to be additionally advertised? On the other hand, how do we know whether to choose company A’s medicine or company […]

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    Is market analysis important for pharmaceutical project success?

    20 lipca 2023

    Big pharma has the unlimited budgets, but is it true? In 2012 the medical and patient world held its breath because of Sanofi’s new product launch – Zaltrap (afibercept), a medicinal product registered for the treatment of colon cancer and its price of 9600 $/month. The price of Avastin (bevacizumab), its closest competitor, was half […]

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    How to increase the safety of used cosmetics? A few words about cosmetovigilance

    12 lipca 2023

    Every day, a lot of people experience side effects after using cosmetics, but not everyone knows that they can report them to the responsible authorities. Why reporting adverse reactions is important and how it affects the safety of cosmetics? If you want to find out what cosmetovigilance is – we invite you to read the […]

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