Good Pharmacovigilance Practice in the United States and the European Union

The article presents the results of a comparative analysis of Goodpharmacovigilance practices (GVP), developed by experts of the regulatory bodiesof the European Union (EU) and the United States. It is shown that the EU GVP cover almost all possible aspects of pharmacovigilance. It is noted that the disadvantages of EU GVP are difficulties in the correct understanding and interpretation of certain definitions and processes, as well as the complexity of the implementation in practice of a number of provisions, mainly related to the organization of the quality management system, including audit and inspection. As the basis for development of the Russian Rules GVP is recommended to use the GVP E

Josephson effects in dilute Bose-Einstein condensates

We propose an experiment that would demonstrate the ``dc'' and ``ac'' Josephson effects in two weakly linked Bose-Einstein condensates. We consider a time-dependent barrier, moving adiabatically across the trapping potential. The phase dynamics are governed by a ``driven-pendulum'' equation, as in current-driven superconducting Josephson junctions. At a critical velocity of the barrier (proportional to the critical tunneling current), there is a sharp transition between the ``dc'' and ``ac'' regimes. The signature is a sudden jump of a large fraction of the relative condensate population. Analytical predictions are compared with a full numerical solution of the time dependent Gross-Pitaevskii equation, in an experimentally realistic situation.Comment: 4 pages, 1 figur

ON THE IMPACT OF DRUG NAMES AND LABELS ON THE RISK OF MEDICATION ERRORS

In this article authors analyze the influence of a label on drugpackage on the risk of medication errors and propose methods of their prevention.Analysis of the corresponding data published by regulators EMA and FDA hasprovided an opportunity to find examples of phonetic and graphic similaritieswith drugs identificatio

On the safety of acetaminophen

Acetaminophen is one of the most commonly used analgesics /anti pyretics. However, taking into account the existing risk of hepatotoxicity,regulatory bodies of a number of the countries made additional adjustments tothe recommendations on the use of this drug. In the article the possible reasonsfor recourse to acetaminophen are discusse

Qualitative methods of benefit / risk assessment

In this article authors describe some existing methods of benefit / risk assessment

Chemical-potential standard for atomic Bose-Einstein condensates

When subject to an external time periodic perturbation of frequency $f$, a Josephson-coupled two-state Bose-Einstein condensate responds with a constant chemical potential difference $\Delta\mu=khf$, where $h$ is Planck's constant and $k$ is an integer. We propose an experimental procedure to produce ac-driven atomic Josephson devices that may be used to define a standard of chemical potential. We investigate how to circumvent some of the specific problems derived from the present lack of advanced atom circuit technology. We include the effect of dissipation due to quasiparticles, which is essential to help the system relax towards the exact Shapiro resonance, and set limits to the range of values which the various physical quantities must have in order to achieve a stable and accurate chemical potential difference between the macroscopic condensates.Comment: 13 pages, 4 figure

LOCAL ANESTHETIC MYOTOXICITY

The article presents the mechanisms of development and methods of correction of myotoxicity associated with use of local anesthetic

USE OF DRUGS DURING THE FIRST TRIMESTER OF PREGNANCY IN TERMS OF FOETUS SAFETY: ANALYSIS OF PRESCRIBINGS

The article presents the results of analysis of the use of drugs in the first trimester of pregnancy from the point of view of safety to the fetu