Purpose
The purpose of this paper is to show that advertising as part of product promotion is in strict correlation with the specific regulation of each product category, food supplements and ...herbal/over-the-counter medicines. Main contributions of the paper are two-fold. First, it demonstrates that there are products when certain botanical is registered according to legislation as herbal medicine, but at the same time it can be found in sales as food supplement. This can happen within the same country, but it is more frequent within different countries. Second, the possibility for regulation harmonization is discussed.
Design/methodology/approach
In this paper, a comparative analysis of regulation for concerned products in European Union and countries of interest is made. In two case studies, a comparative analysis of marketing of the products in Macedonia and Serbia is made.
Findings
Food supplements are subject to more liberal regulation in comparison with herbal/over-the-counter medicines, but should not be attributed indications and properties that they do not possess. Regulation is stricter and more complex for over-the-counter medicines as a separate class of medicines, these must be correlated with registered properties and indications and are subject to approval by regulatory bodies (print media: advertisement in newspaper/magazine, poster, brochure, flyer, banner and billboard and electronic media: TV spot, radio advertising and internet advertisement).
Research limitations/implications
Countries of interest: EU, Macedonia, Serbia, Montenegro, Albania, Kosovo, Bosnia and Herzegovina.
Practical implications
The paper will contribute toward the creation of promotional and marketing steps in placement of these products on the market in countries of interest, based on regulation of the product category.
Social implications
The discussed opportunities for harmonization are applicable and realistic and can positively contribute for better flow and placement of food supplements and herbal/over-the-counter medicines in different countries. The results of the case studies can also be used for regulatory activities and preparation of marketing materials for other products on other markets of interest with same or similar regulation.
Originality/value
For the first time, a comparative analysis of regulation is made for concerned products in countries of interest. Possibility for regulation harmonization is discussed.
The ABCB1 gene encodes the P-glycoprotein (Pgp) protein, which is thought to transport various antiepileptic drugs. The single nucleotide polymorphism (SNP) (C3435T) in exon 26 of this gene ...correlates with the altered expression levels of P-glycoprotein, range of drug response and clinical conditions. In order to investigate the influence of this polymorphism on the susceptibility to and efficacy of carbamazepine therapy, we evaluated the allelic frequency and genotype distribution of this variant in 162 epilepsy patients from the Republic of Macedonia. Statistically significant differences were detected neither in the allelic frequency and genotype distribution between carbamazepine-resistant and carbamazepine-responsive epilepsy patients nor between the subgroups of carbamazepine (CBZ)-responsive patients treated with different CBZ doses. However, the T-allele was enriched in CBZ-responsive patients who required higher maintenance CBZ doses, This observation was substantiated by the findings that the median total plasma levels were the lowest in patients with CC (20 μmol/L) followed by CT (23 μmol/L) and TT (29 μmol/L) genotypes. Patients with a CC genotype also had a higher likelihood of response compared to patients with CT or TT genotypes over a wide range (400-1000 mg/day) of initial doses of CBZ. The T allele showed a reduced expression of ~5% compared to the C allele in peripheral blood mononuclear cells in heterozygotes for the variant. This difference might be translated into ~10% difference in homozygotes for the variant, which would explain the trend towards a dose-dependent efficacy of the CBZ treatment in patients with different genotypes. A larger prospective study is warranted to clarify the clinical utility of a genotypespecific individualized CBZ therapy.
Marketing strategy is correlated with the regulations for the corresponding product category. Accordingly, there is a big difference in the marketing strategy of food supplements and over-the-counter ...medicines. In this paper are presented 2 different marketing strategies of a new small pharmaceutical company in two studies. The findings of studies analysis can be used for developing marketing strategies in the wider sense and other products, for other small to medium sized companies in other countries of interest with similar regulations and help them understand how to position and promote themselves and their products.
The stability of proteins is a subject of intense current interest. Aggregation, as a dominant degradation pathway for therapeutic proteins, may cause multiple adverse effects, including loss of ...efficacy and immunogenicity. In the present study, the formation of aggregates in lenograstim under physiological conditions was monitored. For this purpose, a simple and selective size-exclusion high-performance liquid chromatography method for detection and separation of aggregates from intact protein was developed. Sodium dodecyl sulphate-polyacrylamide gel electrophoresis was performed under reducing and non-reducing conditions to determine the nature of aggregate bond formation. Using both techniques, the presence of a low aggregate content attached via disulfide bonds was detected.
Stabilnost proteina vrlo je aktualna problematika. Agregacija, kao dominantni put razgradnje terapijskih proteina, može uzrokovati različite nuspojave, koje uključuju i gubitak učinkovitosti imunološkog sustava. U ovom radu praćeno je stvaranje agregata u lenograstimu pod fiziološkim uvjetima. Razvijena je jednostavna i selektivna tekućinska kromatografija visoke djelotvornost s isključenjem prema veličini za detekciju i razdvajanje agregata od intaktnog proteina. Pomoću natrij-dodecil sulfat poliakrilamidne gel elektroforeze u reducirajućim i nereducirajućim uvjetima utvrđen je način stvaranja agregata. Pomoću obje tehnike moguće je detektirati prisutnost malih količina agregata koji su spojeni disulfidnim vezama.
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