Blog
Is an uncertain remedy better than none? Exploring the usage of off-label drugs and ensuring treatment in Pregnant and Breastfeeding Women
07 May 2024
A Latin sentence says: anceps remedium melius quam nullum – an uncertain medicine is better than none. Have you ever wondered why the use of drugs in some populations of patients (such as pregnant women or children) is especially encouraged to be reported? The answer to this question is straightforward – it is impossible to […]
Herbal substances – marking the line between the cure and the poison
25 April 2024
Lily of the Valley Day – the eternal question of dose in determining toxicology and therapeutic effect On May 1st some of us celebrate Lily of the Valley Day. This holiday is popular especially in France, known as La Fête du Muguet. On this day, the French give bouquets of lilies of the valley to […]
Primum non nocere – a word about wise use of medicines and reporting adverse drug reactions
28 March 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 […]
How to divide responsibilities in a GMP-related contract? A quality agreement is the answer
18 March 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 […]
Women Participation in Clinical Trials – Conflict, Controversy and Change.
06 March 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 […]
A Brief History of the GMP
20 February 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 […]
The changing face of clinical trials. A long and fascinating journey to effective and safe medicines.
05 January 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 […]
QPPV – the key player in Pharmacovigilance
25 October 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. Who can become the QPPV? What are his key responsibilities? Does each pharmaceutical company have to employ a QPPV?
Replace, Reduce, Refine. Animal testing in drug development.
16 October 2023
Animal testing has long been a crucial aspect of drug development, aiding researchers in understanding the safety and efficacy of potential treatments. However, the ethical concerns and scientific limitations associated with animal testing have prompted the scientific community to embrace the principles of “Replace, Reduce, Refine” (3Rs) to minimize the use of animals and enhance the quality of research in this field.
From crisis to hope. Restoring mental wellness in a post-pandemic world
09 October 2023
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. It is frightening that suicide attempts among children have increased several times compared to the pre-pandemic level. Check what the results of scientific research say about how drastically the level of mental health in our society has decreased and find out how you can help yourself and your loved ones.
Medicinal products advertisement – what is it and what requirements must it fulfill?
02 August 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? Stay informed with the latest medicinal products advertisement regulations and best practices. Read now for expert insights and guidance.
Is market analysis important for pharmaceutical project success?
20 July 2023
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 of its price, since Sanofi’s treatment was so expensive, oncologists turned down the idea of using it. Nowadays, even smaller brands don’t hesitate to spend money for reliable recognition of the market. Does this problem also apply to generic drugs? It may seem that the introduction of a generic drug will guarantee market success. Therefore, is there anything to be afraid of? Is there any risk, anything can go wrong?