This paper presents an analysis of leading foreign regulatory authorities’ requirements for the bioequivalence studies of medicinal products containing analogues of endogenous substances. US Food and Drug Administration, European Medicines Agency, and Eurasian Economic Union’s approaches are discussed. The scientific literature on the bioequivalence studies of endogenous substances, as well as the results of clinical trial and marketing authorization applications assessments which were conducted by the FSBI “SCEEMP” in 2013-2015 are analyzed. General recommendations and principles for design and conduction of the bioequivalence studies of such medicinal products and reporting of their results are proposed, basing on the results of analysis of the foreign requirements, scientific data and domestic experience.

These recommendations present the specifics of laboratory testing and examination of regulatory documents. The recommendations include information about the basic principles of presentation of the quality assessment methods. The paper demonstrates the following: a general presentation scheme of regulatory documents sections with a detailed description of subsections structure, the peculiarities of presentation of the methods for evaluation of physicochemical quality characteristics of immunobiologicals and the typical mistakes made in the process of drafting regulatory documents.

When the quality of antibiotics and antibiotic dosage forms cannot be assessed with the help of chemical methods, one can use two variants of the agar diffusion test described in the State Pharmacopoeia XII, part 1 (General pharmacopoeial monograph 42-006807): the three-doses variant of the agar diffusion test and determination with the help of a standard curve. The method is based on directly proportional relationship between the size of test microorganisms inhibition zones and log concentration (dose) of the antibiotic in the solution placed onto agar bacterial medium. The size of the zone depends on a number of factors: sensitivity of the test microorganism to the antibiotic, homogeneity and density of the bacterial lawn, composition of the growth medium, amount of the growth medium placed on Petri dishes, chemical nature of the antibiotic, the dose of antibiotic used in the experiment. Laboratory employees who use this method to test the quality of antibiotics should have appropriate skills. The activity of the drug under testing is determined by comparing it to the established activity of the reference standard which should have compendial quality. Statistical methods are used to assess obtained results and confirm validity of test conditions. The precision of test results is confirmed by computing the 95% confidence interval, and the repeatability is supported by calculation of the relative standard deviation.

The paper describes the basic quality parameters of the starting materials of herbal origin and herbal drugs, taking into account the requirements of State Pharmacopeia XI and draft general chapters of State Pharmacopeia XIII. It enlists the main terms and definitions, and the requirements to presentation of the quality parameters. It provides the examples of typical criticism of the normative documents on herbal drugs in terms of various quality parameters, including “Appearance”, “Identification tests”, “Chromatography”, “Degree of fineness”, “Assay”. The criticism has been leveled at the quality of both draft normative documents and the samples submitted for testing. The survey conducted allows for explaining the expert requirements to the quality of samples and the presentation of several test methods.

The article describes the basic principles of validation of the databases and laboratory information management systems used by pharmaceutical organizations. The principles are arranged on the basis of international OMCL network requirements and ISO standards. The article presents the general approaches to validation of these types of information systems and evaluation of soft- and hardware choices, and the requirements to the procedure of installation and the settings of those. It contains the requirements to test data sets and general methodology for conducting the validation tests. Additionally, it covers the possibility to validate not only new software, but also the software currently in use.

The article elaborates on a general overview of the tracing system and the possibilities of its implementation in the circulation of medicines. Moreover, it presents several variants of pharmaceutical production marking and the characteristics of those. The article touches upon the challenges of drug samples tracing system information support.

The article presents relevant information on the features of cytochrome P450 isoenzyme CYP2D6 functioning. 20-25% of drugs are metabolized by the action of CYP2D6. Determination of its activity allows for adjusting pharmacotherapy to increase the efficacy and safety of a drug or a combination of drugs. Cytochrome P450 isoenzymes genotyping and phenotyping methods allow for choosing the dosage and dosing regimen for patients on an individual basis. This article describes the genetic characteristics affecting CYP2D6. CYP2D6 polymorphism has a significant impact on pharmacokinetics and metabolism of a drug. This may lead to side effects, or decrease the pharmacological action of the drug. The article covers the cases of change in clinical response to receiving β-blockers (metoprolol), antidepressants (venlafaxine) and opioids (codeine). These changes occurred in the presence of certain CYP2D6 alleles which speed up or slow down the metabolism. It also provides information on drug-drug interactions involving inhibition of cytochrome P450 isoenzyme CYP2D6. Genotyping methods are used to determine the potential activity of CYP2D6. Dose adjustment is carried out basing on the results obtained. The current isoenzyme status is defined by phenotyping methods. CYP2D6 activity can be evaluated by determining the ratio of the substrate and its metabolite using HPLC. Pinoline, which is metabolized to 6-hydroxy-1,2,3,4-tetrahydro-β-carboline, is the endogenous substrate for estimating the activity of CYP2D6.

Animal experiments are fundamental for the biomedical science. The development of new drugs is always associated with a large number of preclinical experiments in animals. Experimental data make it possible to predict the drug efficacy and safety in humans. There are more than 100 million laboratory animals that are used by researchers every year worldwide. This fact raises a number of concerns regarding the legality and ethical appropriateness of using such a large number of animals. This article discusses the problem of using an unreasonably large number of experimental animals during preclinical drug studies, as well as potential ways of streamlining existing methods used for determining the acute and subacute toxicity of drugs in order to minimize the time of the study and the number of animals used. In addition, we review the problem of systematizing experimental data and potential ways of their standardization in line with the European legislation regulating ethically approved use of animals in experiments.

Early determination of educational needs of specialists is one of the most important tools of improving teaching and learning activities within the system of continuing professional education. For this purpose the Center of Educational Programmes of the FSBI «SCEEMP» has surveyed about 350 specialists engaged in the sphere of medicines circulation. The survey respondents participated in seminars and professional development programmes, which were provided by the Center of Educational Programmes in 2014. This article presents the results of this opinion poll.

Blood products were first represented in the State Pharmacopoeia of the USSR IX and X editions (1961 and 1968) by a single monograph "Gamma globulin for the prevention of measles". During the next 50 years there were no general monographs (GM) or individual monographs (IM) in the State Pharmacopoeia of the Russian Federation that laid down regulatory requirements for the quality of human blood products. In this regard, there came a need to develop GMs and IMs on human blood products taking into account modern approaches, specific features of a complex multi-level production technology and modern harmonized requirements for blood products, ensuring their quality, efficacy and safety in humans. The Order of the Ministry of Health of the Russian Federation "On the adoption of general monographs and individual monographs” No. 768 of 21.11.2014 brought into effect 32 GMs and IMs on blood products, including 11 GMs and 5 IMs that have been introduced into the national pharmacopoeial texts for the first time. The monographs were developed with due regard to modern pharmacopoeial methods of analysis that account for a high level of quality control of this type of products.

The article reviews major ways of streamlining approaches to testing the following quality parameters of drugs presented in the dosage form oftablets: “Identification”, “Dissolution”, “Disintegration”, “Related impurities”, “Residual organic solvents”, “Assay”. The article describes results of a comparative analysis of requirements laid down in the leading world pharmacopoeias, WHO documents and national requirements for tablets standardization. The analysis covers such issues as classification of drugs, terms used to describe various tablet groups, differences in the choice of test methods, as well as in approaches to assessment of parameters and use of reference standards. The analysis makes it possible to define national requirements for tablets quality, which is particularly important in view of the future work on the development of pharmacopoeial monographs on drugs for the State Pharmacopoeia of the Russian Federation.

Cerebral palsy (CP) is one of the most widespread and socially significant neurological diseases that affect both various aspects of physical and psychoverbal development of children since birth and stages of their personal development and adaptation in society. Over the last years there has been an increase in the number of children with disabilities in Russia, and it should be noted that CP ranks first among neurological disabilities in children. Given the lifetime course of this disease, CP acquires a huge medical and socioeconomic relevance. In particular, it is necessary to use the most efficient medical technologies (from the point of view of both efficacy, safety and costs). Pharmacoeconomic analysis is the most suitable tool for solving these tasks. However, when performing pharmacoeconomic analysis in the field of cerebral palsy, as well as in any other disease area, it is obligatory to take into account certain peculiarities at the planning and implementation stages. The authors of the article have identified specific features of pharmacoeconomic analysis methods based on assessment of health technologies related to cerebral palsy.