Аліментні обов'язки інших членів сім'ї та родичів

Виявлено проблеми у врегулюванні аліментних обов’язків інших членів сім’ї та родичів, вироблено рекомендації щодо їх вирішення. Проаналізовано специфіку правового регулювання аліментних зобов’язань зазначених суб’єктів, сімейне законодавство та міжнародний досвід. Ключові слова: аліментні обов’язки, правове регулювання, сімейне законодавство.Выявлены проблемы в урегулировании алиментных обязанностей других членов семьи и родственников, выработаны рекомендации по их решению. Проанализирована специфика правового регулирования алиментных обязательств указанных субъектов, семейное законодательство и международный опыт. Ключевые слова: алиментные обязанности, правовое регулирование, семейное законодавствоThis article is dedicated to identifying problems in the regulation of the alimentary obligations of other family members and relatives, and to making recommendations and proposing solutions. Studing the specificity of the legal regulation of alimentary obligations of these entities, analysing the current family law and international experience are very important. Key words: alimentary obligations, legal regulation, family law

Paediatric Drug Development and Formulation Design—a European Perspective

The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize “better” medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the “Guideline on the Pharmaceutical Development of Medicines for Paediatric Use.” Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline’s key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions

Oral medicines for children in the European paediatric investigation plans

INTRODUCTION: Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered also. The plans for such paediatric development called Paediatric Investigation Plans (PIPs) are subject to agreement by the European Medicines Agency (EMA) and its Paediatric Committee (PDCO). The aim of this study was to evaluate the key characteristics of oral paediatric medicines in the PIPs and the changes implemented as a result of the EMA/PDCO review. METHODS: All PIPs agreed by 31 December 2011 were identified through a proprietary EMA-database. PIPs were included if they contained an agreed proposal to develop an oral medicine for children 0 to 11 years. Information on the therapeutic area (EMA classification system); target age range (as defined by industry) and pharmaceutical characteristics (active substance, dosage form(s) as listed in the PIP, strength of each dosage form, excipients in each strength of each dosage form) was extracted from the EMA website or the EMA/PDCO assessment reports. RESULTS: A hundred and fifty PIPs were included corresponding to 16 therapeutic areas and 220 oral dosage forms in 431 strengths/compositions. Eighty-two PIPs (37%) included tablets, 44 (20%) liquids and 35 (16%) dosage forms with a specific composition/strength that were stored as a solid but swallowed as a liquid e.g. dispersible tablets. The EMA/PDCO review resulted in an increase of 13 (207 to 220) oral paediatric dosage forms and 44 (387 to 431) dosage forms with a specific composition/strength. For many PIPs, the target age range was widened and the excipient composition and usability aspects modified. CONCLUSION: The EMA/PDCO review realized an increase in the number of requirements for the development of oral dosage forms and a larger increase in the number of dosage forms with a specific composition/strength, both targeting younger children. Changes to their pharmaceutical design were less profound

Excipients in the Paediatric Investigation Plans (n = 150); group wise comparison.

<p>*a preparation is a subtype of a dosage form in a particular strength and with a particular excipient composition.</p>%<p>excipient that has raised special attention by regulators in recent years due to a non-confirmed safety signal.</p>&<p>studied by McCann et al. in the Southampton study and considered as potentially harmful <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0098348#pone.0098348-McCann1" target="_blank">[18]</a>. The study conclusion was questioned by EFSA <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0098348#pone.0098348-Scientific1" target="_blank">[19]</a>.</p>#<p>may be used as a safe(r) alternative to the colourants studied by McCann et al. <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0098348#pone.0098348-McCann1" target="_blank">[18]</a>.</p

Oral preparations in the PIPs per target age group.

<p>Oral preparations in the PIPs per target age group.</p

Tablet size and shape (n = 150 PIPs); group wise comparison children aged between 2 and 6 years.

<p>*tablets counted as the number of oral preparations i.e. differentiated to excipient composition and strength. A small tablet wa defined as 0–4 mm, medium sized 5–9 mm and large 10 mm or larger <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0098348#pone.0098348-European8" target="_blank">[21]</a>. Oval tablets included those that were oblong or capsule shaped.</p>&<p>related to the two tablets sized 10 mm or larger.</p

PIPs including at least one oral medicine for children 0–11 years.

<p>PIPs including at least one oral medicine for children 0–11 years.</p

Oral medicines in the Paediatric Investigation Plans (n = 150 PIPs); group wise comparison.

<p>*a preparation is a subtype of a dosage form in a particular strength and with a particular excipient composition e.g. a PIP containing film-coated tablets 50 mg and chewable tablets 5, 10 and 20 mg represents one overall dosage form (tablets), two tablet subtype dosage forms (film-coated tablets and chewable tablets) and four preparations (film-coated tablets 50 mg, chewable tablets 5 mg, chewable tablets 10 mg, chewable tablets 20 mg).</p