Quo vadis pharma industry?

Jakub Rak, Vladimír Král

Klin Farmakol Farm. 2014;28(1):5-7  

Where from and where the pharmaceutical industry walks? In recent years there has been a dramatic reassessment of goals of large pharmaceutical companies from search for new substances to the reincarnation of the old molecules with new applications. Changes of market conditions force industry to rigorous life cycle management of pharmaceuticals. Trends also show a shift away from small molecules to biomedicine and sophisticated nanomedicine. The emphasis is slowly shifting from simply treating the quality of life, from the universality to personalized medicine. Companies that do not adapt to these trends will face an uncertain and worrying future.

Slovo úvodem

MUDr. David Suchý, Ph.D.

Klin Farmakol Farm. 2014;28(1):3  

The impact of VZP CR interventions on drug interaction prescrbing physicians in Kralovehradecky and Stredocesky regions

Michal Prokeš, Pavel Pechánek, Taťána Soharová, Lubomír Dvořáček, Josef Suchopár

Klin Farmakol Farm. 2014;28(1):8-13  

Introduction: Drug-drug interactions are one of the causes of adverse drug reactions. VZP ČR, which is the largest health insurance fund in ČR, in 2010 ascertained the frequency of potential drug interactions (PLI) of warfarin, cardiovascular drugs and NSAID in two Czech regions. To physicians who prescribed PLI the „dear doctor letter“ was send and the physicians were invited to educational seminaries where prescribed PLI were discussed. Aim of this study is to examine the effect of the educational interventions on drug prescription in Královéhradecký (HK) and Středočeský (SC) region. Design: Prescription data from VZP database...

Biosimilars - specific features of the approval process in the European Union

Jan Strojil

Klin Farmakol Farm. 2014;28(1):14-18  

With several high-profile biologics nearing the expiration of their patents, the focus is now on follow-up biologic products, also called biosimilars. This paper reviews the current European Union regulation of the biosimilar approval pathway, particularly in contrast to the traditional generic drug approval process. Using the example of biosimilar infliximab, the paper describes the main specific features of the development and characterization of biologics, including a current discussion on nomenclature and patient, physician information, and automatic substitution.

First biosimilar monoclonal antibody introduced to clinical praxis: infliximab

Karel Urbánek

Klin Farmakol Farm. 2014;28(1):19-22  

Infliximab CT-P13 is the first monoclonal antibody that has been tested in accordance with the European Medicines Agency for biosimilars and also has been approved. The article summarizes the results of preclinical and clinical evaluation of this particular substance and its comparison with the original product.

Pharmaco-economics of biological treatment; focus on biosimilars

Jana Skoupá

Klin Farmakol Farm. 2014;28(1):23-25  

The article describes the history of biosimilar products and current status. Biosimilars represent a group of biological products with comparable efficacy and safety to the reference substance, although it is not appropriate to call them “generics“. Health-economic analyses in biosimilars usually apply cost-minimization, which strictly requires equal efficacy and safety of the assessed substance and comparator. Available literature shows, that biosimilarsare cost-saving, the estimated potential of savings is currently in the range of 15–30 %.

Effect of the infusion system on the quality of parenteral treatment

Karel Urbánek, Martin Poruba, Pavlína Štrbová

Klin Farmakol Farm. 2014;28(1):26-30  

Currently used containers for intravenous infusion solutions are primarily PVC or non-PVC collapsible and semi-rigid plastic containers. Main advantage of flexible containers is the fact that they do not need venting for optimal emptying, thus can be used in closed infusion systems. This minimizes the risk of contamination by the pathogens from the environment, reducing the risk of serious nosocomial infections. Furthermore, after the use only a small residual volume remains in the container, which means that the dosage of the dissolved medicaments is very accurate.

Steroid resistant asthma: classification, definition and molecular mechanisms

Jan Potěšil, František Kopřiva, Marek Godava, Mariana Svetlíková

Klin Farmakol Farm. 2014;28(1):31-36  

of the glucocorticoid resistance on the cell level Asthma is one of the most frequent chronic inflammatory disease amongst czech population. Generally asthma is caused by insufficient or inadequate regulation of systemic inflammatory activity manifested by chronic inflammatory changes in the airways of respiratory system. Complex treatment strategy, management approach based on treatment steps, is used in the treatment, with application of immunomodulatory drugs as a pharmacological base. Inhaled glucocorticoids are the drug of choice and concurrently the most often aplicated immunomodulatory drug amongst asthmatics. Glucocorticoid resistance...

Biosimilars - šance pro úsporu peněz v evropských zdravotních systémech

Klin Farmakol Farm. 2014;28(1):36  

Účinnost a bezpečnost přípravku Zarzio® potvrzují výsledky klinických studií i praktické zkušenosti lékařů

Petra Tesařová

Klin Farmakol Farm. 2014;28(1):37-38