O. O. Zavada, V. I. Gusarov, S. M. Gubar, I. O. Zhuravel, S. M. Kovalenko
DEVELOPMENT AND VALIDATION OF METHOD OF DETERMINATION RELATED SUBSTANCES IN THE SUBSTANCES 3-(TRIFLUOROACETYL)-IMIDAZO[1,2-a] PYRIMIDINE DURING THE PHARMACEUTICAL DRUG DEVELOPMENT
A HPLC method for related substances of 3-(trifluoroacetyl)-imidazo[1,2-a]pyrimidine determination was developed. The impurities of newly synthesized derivative of imidazo[1,2-a] pyrimidine chromatographic profile was studied using reversed-phase HPLC. The created HPLC methodic was validated.
Key words: imidazo[1,2-a]pyrimidine, HPLC, validation.
V. О. Lebedinets
DEFINITION OF THE ROLE AND THE BASIC FUNCTIONS OF THE SUPERVISING PERSONNEL AT FORMATION AND SUPPORT OF FUNCTIONING OF THE QUALITY MANAGEMENT SYSTEM AT THE ENTERPRISE FOR MANUFACTURE OF MEDICAL PRODUCTS
In article requirements of national edition of guidelines for GMP, ICH Q10 and standard ISO 9001 to a role and the basic functions of the supervising personnel in implementation and functioning of the quality management system of the enterprise for manufacture of medical products (pharmaceutical quality system) are analyzed. Recommendations about performance of requirements, and also about rational distribution of duties among the top management for pharmaceutical quality system are formulated.
Key words: management representative for quality, the enterprise for manufacture of medical products, quality management system, pharmaceutical quality system, good manufacturing practice (GMP), ICH Q10, ISO 9001.
K. L. Ratushna, K. O. Zupanets, V. Ye. Dobrova, А. M. Kotenko
RESEARCH OF ASPECTS OF DATA QUALITY RISKS MANAGEMENT IN CLINICAL TRIAL
The essential component of risk management conception realization in clinical trials is potential risk identification and assessment. The quality of these processes depends on thoroughness of analysis of information regarding internal and external factors that can result in risks of non-compliance occurrence and negatively affect the data quality and
clinical trial results integrity as a whole. In the paper the possible data quality risk factors were proposed, and its significance to non-compliance occurrence was determined by surveying the experts. On the base of the results obtained the list of particular and integral factors needed to be considered in risk management was created. Also risk factors were grouping depending on the direction and the power of its impact. The general model of data quality risk management was developed.
Key words: clinical trial, clinical data management, risk management, risk factor.
V.I. Gorodetskaya, V.A. Lebedynets, S.N. Kovalenko
DEFINITION AND ANALYSIS OF EMPLOYERS REQUIREMENTS TO EXPERTS IN QUALITY MANAGEMENT FOR PHARMACEUTICAL SECTOR
On the basis of questioning the main requirements of employers to a professional knowledge and skills of experts in the quality management, necessary for work at the enterprises for manufacture of medical products are defined. It is investigated module-competent model of the expert in quality management in pharmacy. On the basis of the received information the average factor of the importance and the percentage importance is special-professional competent and disciplines of an is professional-practical cycle training for future quality management experts in pharmacy are defined.
Key words: training in quality management module and competency model, specialized and professional competence, discipline, vocational and practical training cycle, the pharmaceutical quality system.
MODELLING OF EXPENSES FOR LIQUIDATION OF CONSEQUENCES OF MEDICINES’ ADVERSE REACTIONS
The method of calculation of direct expenses for liquidation of consequences of medicines’ adverse reactions has been developed and is mathematically justified. The offered algorithm of calculations allows to optimize or to reduce costs for treatment of patients, to prevent emergence or to minimize losses from a number of specific risks connected with occurrence of medicines’ adverse reactions.
Key words: medicines, adverse reactions, expenses, safe use, rational therapy.
I. E. Kuznetsov
PHARMACOECONOMIC ESTIMATEOFPHARMACOTHERAPY OF THE COMMUNITY-ACQUIRED PNEUMONIAIN CHILDREN
The pharmacotherapy’s estimate of pediatric patients with the community-acquired pneumonia, who underwent treatment in therapeutic department of one of Kharkov’s children’s hospital, has been carried out by means of the auxiliary pharmacoeconomic methods: ABC-, VEN- and frequency analysis. Thorough review of medical records, selected for the study, allowed to ascertain that the primary majority of prescribed medicinal preparations (75 %) are presented in ukrainian clinical protocols of the children’s community-acquired pneumonia and accompanying diseases treatment. These preparations was found to represent the greater part of medical prescriptions – 71,23 %. Main portion
of financial means (86,32 %) in given department has been spent out to cover expenses connected with pharmaco-therapy of pediatric patients suffering from the communityacquired pneumonia. In the whole, pharmacotherapy aproarch discussed is considered to be rational both from clinical and economic points of view, but it needs further correction in accordance with the clinical protocol.
Key words: community-acquired pneumonia, pediatric patients, pharmacoeconomics, ABC-analysis, VEN-analysis, frequency analysis
К. I. Dorykevych
THE ASSESSMENT OF THE ECONOMIC AFFORDABILITY OF HORMONAL CONTRACEPTIVES
There was assessed economic affordability of hormonal contraceptives with the real state income consumers (patients) – the average wage and the subsistence minimum.
Key words: reproductive health, family planning, hormonal contraceptives, economic affordability.
A. A. Kotvitska, I. О. Lobova
ANALYSIS OF CONSUMPTION OF NEUROPROTECTIVE DRUGS FOR THE TREATMENT OF ISCHEMIC STROKE IN UKRAINE
The article investigates the main trends in the development of the pharmaceutical market of neuroprotective action drugs in Ukraine over the past four years. Also the analysis of indicators in sales of neuroprotective action drugs in natural and monetary units. An important aspect of the work is to determine the ratio of consumption of neuroprotective drugs of domestic and foreign production within each pharmacotherapeutic group of drugs.
Key words: pharmaceutical market of Ukraine, neuroprotective drugs, ischemic stroke, the volume of sales.
L. V. Iakovleva, A. V. Rybka
СEREBROPROTEKSIYA IN ASPECTS EVIDENCE-BASED MEDICINE: CEREBROLYSIN AND PIRACETAM
During work we have identified the consumption of nootropics in Ukraine in physical units, including to trace the trend of consumption of drugs piracetam and cerebrolysin. Searched for the evidence base of piracetam for cognitive impairment and identify the effectiveness of piracetam and cerebrolysin the treatment of acute ischemic stroke (АIS). Piracetam, piracetam in combination with cinnarisin were leaders of consumption (in number of packings) during 2008-2011 years in Ukraine. In most countries, including the USA and Western Europe, piracetam and cerebrolysin not registered as drugs and refers to the biological active additives.
Key words: acute ischemic stroke, piracetam, cerebrolysin, clinical trials, meta-analysis.