Sinisa Tomić's research while affiliated with Agency for Medicinal Products and Medical Devices and other places
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Publications (40)
Biological effects of flavonoids have been extensively studied in the last 80 years. As flavonoids represent a rather large group of compounds, data on metabolic biotransformations of these compounds is relatively limited to those well studied. The objective of this study was to screen the metabolism of 30 selected flavonoid aglycons mediated by th...
One of the most important groups of metabolic enzymes is cytochrome P450 superfamily. These enzymes are important in terms of the catalytic diversity and the large number of xenobiotics that are detoxified or activated by converting to reactive metabolites. Flavonoids are xenobiotics to which humans are exposed through diet. Data on their oxidative...
Only medicinal products with marketing authorisations issued by the Agency for Medicinal Products and Medical Devices (HALMED) or the European Commission or medicinal products with authorisations for parallel import or parallel distribution may be on the Croatian market. In order to provide an appropriate care for patients, the current Medicinal Pr...
In view of an increasing number of generic drugs emerging, a comparative study was performed including the approved lisinopril preparations in the form of tablets marketed in Croatia, to compare purity profiles of generic drugs versus the original medicinal product. Several batches of each individual medicinal product at different stages of their s...
Aim
To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence.
Methods
In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug...
Among natural compounds, present in every day diet, flavonoids have shown beneficial effect in prevention of cardiovascular diseases that can be attributed, at least partially to the described antiaggregatory activity i.e. antiplatelet effects of flavonoids. Due to the ever increasing pharmacological interest in antiplatelet agents a systematic exp...
Herbal medicines are traditionally considered natural and therefore safe products, but their increased consumption also increases the potential risk of interactions with conventional medicines and adverse reactions. Adverse reactions of herbal medicinal products may also occur because of the innate herbal toxicity, biological or chemical impurity o...
Counterfeit medicines are a growing problem in the world for they pose an enormous public health risk. The manufacture of counterfeit medicines usually involves organized crime groups which place the counterfeit medicines on the market for reasons of profit. Detection and prevention of trade in counterfeit medicines requires close cooperation betwe...
Quality Control of Seasonal Influenza Vaccines
The purpose of seasonal influenza vaccination is to prevent its spread. The vaccines contain strains of the influenza virus recommended and approved for a particular season. Just like any other medicinal product, all vaccines require marketing approval. Batches of approved vaccines are extensively test...
Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities
In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same...
Olives can be contaminated with various moulds particularly Aspergillus species. Several reports showed that olives support growth of mycotoxin-producing aspergilli as well as production of aflatoxin (AFB1) and ochratoxin A (OTA) during storage period. Therefore, these and other lipid soluble mycotoxins could be transferred into olive oil. The aim...
Hydroxymethylglutaryl-CoA reductase inhibitors (statins) are drugs used in the treatment of chronic diseases and frequently in concomitant therapy with many other drugs. Therefore, the risk of adverse drug reactions (ADRs), especially those caused by interactions is high. Aim of the study was to describe and analyze ADRs caused by statins reported...
New European Commission Regulation on Variations to the Terms of Marketing Authorisation for Medicinal Products and its Impact on Croatian Legislation
Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely alig...
The objective of analysis of ADRs caused by drugs that pertain to the ATC group N (nervous system), as reported to the Croatian Agency for Medicinal Products and Medical Devices for the period from March 2005 to December 2008, was to examine the types of ADRs collected in said period, the profile of reporters and the possible impacts this could hav...
Due to their popularity as a complementary therapy in many diseases, homeopathic products of animal, vegetable, mineral and chemical origin should be tested for the presence of contaminants to prevent eventual toxic effects.
Thirty samples of homeopathic products were analyzed to estimate possible contamination with potentially toxic elements: Pb,...
The regulatory system for medicinal products includes the existence of a legislative framework and a medicines agency as the regulatory body. The legislative framework for medicinal products has been amended several times so as to align it with the EU acquis communautaire, where medicinal products represent one of the best regulated and aligned are...
Thirty samples of widely used vitamins and herbal preparations distributed on the Croatian market were analyzed by atomic absorption spectrometry in order to estimate contamination with Pb, Cd, As, Hg, Cr, Ni and Zn due to their potential toxicity if present above the maximum allowable levels (MAL). The following concentration ranges were obtained...
European legislation for medicines places the emphasis on an assessment of quality, safety and efficacy during the procedure for the granting of marketing authorisations for medicines, in order to protect patient health. The integrated European regulatory system involves the participation of a network of experts from the agencies of the member stat...
To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges.
Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency's database and analyze...
Identification of Counterfeit Medicines for Erectile Dysfunction from an Illegal Supply Chain
The appearance of counterfeit medicines in supply chains is a global public health problem that may seriously affect patients. Counterfeit drugs do not meet quality standards and do not declare their real composition and/or source for the purposes of fraud...
Counterfeit medicines are a growing problem in the world, for their use may endanger patient's health and therefore they pose an enormous public health risk. The manufacture of counterfeit medicines usually involves organised crime groups which place the counterfeit medicines on the market for reasons of profit. Detection and prevention of trade in...
Counterfeit medicines are a growing problem in the world, for their use may endanger patient’s health and therefore they pose an enormous public health risk. The manufacture of counterfeit medicines usually involves organised crime groups which place the counterfeit medicines on the market for reasons of profit. Detection and prevention of trade in...
This influenza season, alongside the seasonal influenza, many people may come down with the pandemic influenza A(H1N1) 2009/2010, caused by a new influenza virus A(H1N1) that is popularly called the »swine flu«. One of the most effective means for preventing infection during the influenza pandemic and for controlling the spread of the disease is in...
Contaminants of Medicinal Herbs and Herbal Products
Medicinal plants have a long history of use in therapy throughout the world and still make an important part of traditional medicine. Thus, medicinal plants and herbal products must be safe for the patient (consumer). This review addresses biological contaminants (microbes and other organisms) and...
Aim To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. Methods Clinical trial applications reviewed by the Croa-tian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices...
64 Benzodiazepine derivatives consumption in the Republic of Croatia in 2005, 2006 and 2007 - Volume 21 Issue S2 - P. Draganic, S. Zezelic, V. Macolic-Sarinic, S. Tomic
To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee.
Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retros...
There is a general lack of scientific literature dealing with the mineral composition of propolis, despite the fact that the presence of minerals in plant tissues can significantly affect the pharmacotherapeutic properties of derived products. Raw propolis samples collected from different Croatian regions and their respective tinctures were therefo...
There is a general lack of scientific literature dealing with the mineral composition of propolis, despite the fact that the presence of minerals in plant tissues can significantly affect the pharmacotherapeutic properties of derived products. Raw propolis samples collected from different Croatian regions and their respective tinctures were therefo...
Three spectrophotometric methods for the quantitative determination of different flavonoid groups and total phenolics in Croatian propolis samples were optimised and validated. The assay based on the formation of aluminium chloride complex (with galangin as a standard) was applied to the quantification of flavones and flavonols, while the 2,4-dinit...
A lot of factors such as temperature, light exposure, water availability, nutritients, period and site of collection, age and part of plant collected, method of collection, processing (drying, chemical/radioactive treatment,...), storage and distribution of starting herbal material, etc., can greatly affect the quality and consequently the therapeu...
Citations
... 25 According to the study done by Goran Benkovi c et al., CYP2C19 and CYP2D6 enzymes were found to be responsible for galangin metabolism. Incubations of CYP2C19 and CYP2D6 revealed the production of one metabolitekaempferol-similar to the studies using human liver microsomes, suggesting that this enzyme catalyzes the aromatic hydroxylation of galangin at position 4' of ring B. 26 Liu et al. identified two galangin metabolites in rat plasma using ultra-fast liquid chromatography coupled with electrospray ionization triple quadrupole tandem mass spectrometry (UFLC-MS/MS). After oral treatment, two galangin metabolites, galangin-3-O-D-glucuronic acid (GG-1) and galangin-7-O-D-glucuronic acid (GG-2), were identified, reiterating the result that galangin was glucuronidated. ...
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... Liver act in the detox i fi ca tion process via coun ter ing var i ous ex oge nous and en dogenous chal lenges ( Kshirsagar et al., 2011 ). Ex oge nous com pounds (xeno bi otics such as al co hol, nico tine and drugs) ( Benković et al., 2019 ) are mainly me tab o lized in the liver by bio trans for ma tion phase I and II. Briefly, the bio trans for ma tion phase I re ac tions are ma jorly in volved in the ex po sure of func tional groups on the drug through oxi da tion, re duc tion, and hy drol y sis ( Tripathi, 2013 ). ...
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... The concentration of 14 elements, namely zinc (Zn), copper (Cu), manganese (Mn), magnesium (Mg), cobalt (Co), potassium (K), sodium (Na), iron (Fe), selenium (Se), calcium (Ca), lead (Pb), nickel (Ni), chrome (Cr) and molybdenum (Mo) in nut samples was analyzed according to the method described in the literature [76]. The determination was performed using an AA280 FS/Z AA spectrometer (Agilent Technologies, Santa Clara, CA, USA) equipped with a single-element hollow cathode lamp. ...
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... Cultural changes and understandings, flow of ideas about the current events, the occurrence and endemicity of new infectious diseases of humans in new areas, the world events of disease pandemic, outsourcing jobs and resources, economics and environmental conditions are a few byproducts of human mobility. In fact the 1918–1919 influenza pandemic1234 and the sociocultural changes in societies [6] are a few illustrations exhibiting the movement of people. Many studies regarding the mobility of the human species consider its impact in spreading infectious diseases between communities as a result of the movement of people, goods, vectors and animals across the globe. ...
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... This often involves the quantitation of one or two analytes to assess the chemical variability of a commercial herbal product. This type of analysis is woefully insufficient when it is used for the QC of chemical formulations with multiple herbal products [7][8][9][10][11]. A more comprehensive and rigorous method is required. ...
... Shelf-life -It is recommended that in case of a herbal medicinal product containing a natural product or a herbal drug preparation with constituents of known therapeutic activity, the variation in component during the proposed shelf-life should not exceed ± 5% of the initial assay value, unless justified to widen the range up to ±10 per cent or even higher [14]. ...
... A 6-year retrospective study in Bengbu in China showed that among the ADRs reported between nervous system drugs in hospitalized patients, 12.14% of the ADRs were associated with potential and actual DDIs, and actual DDIs were present in 6.21% of all ADRs (Shi et al., 2014). However, the incidence of ADRs resulting from DDIs could not be accurately estimated primarily because of differences in study designs and populations (Mirosevic Skvrce et al., 2011). ...
... Propolis acquired from different regions in Croatia was found to contain calcium, potassium, magnesium, sodium, aluminum, boron, manganese, nickel, chromium, barium, zinc and lead. Among analysed minerals, Ca, Mg, K, Al, Fe and Zn were found to be the most abundant in raw propolis, ranging from 12.06 for Mg to 932.6 mg/100 g for Zn (Cvek et al., 2008). ...
... Bee combs can show acaricidal activity from 3 months to 1 year of application, and resistance to one VMP can build up resistance to another [19]. Residues of authorized and no-longer authorized acaricides, e.g., bromopropylate, have been reported in propolis [32,35,36]. If a lipophilic acaricide is no longer used, residues are gradually diluted through newly produced wax that has not been exposed to the specific acaricide. ...
... The most commonly used techniques for the analysis of chemical composition of dietary supplements based on plant extracts is liquid chromatography coupled to a detector (UV/Vis) or photodiode array (PDA) [24,25], or a charged aerosol detector (CAD, Corona detector) [26], gas chromatography with a flame ionization detector (FID) [27] or mass spectrometry with a triple quadrupole coupled with gas chromatography (GC-MS/MS) [28]. Studies dealing with the analysis of metals have used inductively coupled plasma mass spectrometry (ICP-MS) [29,30] or atomic absorption spectrometry (AAS) [31,32]. The determination of trace elements in plants by ICP-MS or FAAS allows rapid analysis with good precision and accuracy. ...
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