- MeSH
- Biosimilar Pharmaceuticals * therapeutic use MeSH
- Technology, Pharmaceutical MeSH
- Humans MeSH
- Drug Substitution trends MeSH
- Check Tag
- Humans MeSH
- Publication type
- Newspaper Article MeSH
- MeSH
- Hypercholesterolemia drug therapy mortality therapy MeSH
- Hypolipidemic Agents therapeutic use MeSH
- Coronary Disease drug therapy mortality therapy MeSH
- Humans MeSH
- Lipoproteins, LDL blood MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Review MeSH
- Comparative Study MeSH
- Geographicals
- United States MeSH
Demographers have constantly tried to find a way of modelling the relationship between mortality and age. So far the Gompertz-Makeham function was for a long time universally used and considered sufficient. As a result of improving oldest-old mortality and better statistical data many new models have emerged that try to illustrate better the development of mortality with age. In this article, some of those models are introduced and fitted to Czech mortality data. Based on the results it is possible to specify three groups of models. The Gompertz-Makeham function belongs to the most pessimistic one, leading to the underestimation of the probabilities of survival and life expectancy.
- MeSH
- Financing, Organized MeSH
- Humans MeSH
- Mortality MeSH
- Models, Statistical MeSH
- Statistics as Topic MeSH
- Vital Statistics MeSH
- Age Factors MeSH
- Check Tag
- Humans MeSH
- Geographicals
- Czech Republic MeSH
- MeSH
- Child MeSH
- Adult MeSH
- Thyroid Hormones blood MeSH
- Hypothyroidism * blood MeSH
- Infant MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Child, Preschool MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Child MeSH
- Adult MeSH
- Infant MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Child, Preschool MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Publication type
- Overall MeSH
- Geographicals
- England MeSH
- United Kingdom MeSH
Biologická léčiva jsou ze své povahy komplexnější než léčiva chemická. Na jejich kvalitě a bezpečnosti se kromě primární struktury podílí i struktura sekundární a terciární, posttranslační změny, biologické, imunochemické a fyzikálně‑chemické vlastnosti. Vzhledem k této komplexnosti je v podstatě vyloučeno, aby „kopie“ originálních léčiv po vypršení jejich patentové ochrany byly strukturálně totožné s originálem. Proto byl vypracován princip biosimilarity, a to na základě komparability a extrapolace indikací. Ty vychází z již dříve používaných postupů, které se aplikovaly např. při změně výroby přípravku. V rámci EU je regulace schvalování a používání biosimilars dvoustupňová – registrace je v rukou Evropské lékové agentury, na úrovni národní potom otázka cen a úhrad a jejich zaměnitelnosti. V rámci regulace registrace jednotlivých přípravků jsou důležitou součástí předpisy upravující možnosti extrapolace dat mezi jednotlivými indikacemi, stanovení kritických kvalitativních parametrů pro posouzení komparability atd. Oproti původní rezervovanosti odborné komunity vůči extrapolaci je na základě nových dat o bezpečnosti nyní princip extrapolace šířeji akceptován. Klíčovou rolí farmaceuta je v každém případě fungovat jako klíčový odborník v edukaci a konzultační činnosti i při optimalizaci lékové politiky.
The biologic drugs are naturally more complex than drugs of chemical origin. Their efficacy, quality and safety are influenced by their primary, secondary and tertiary structure, post-translational changes, biologic, immuno-chemical and physico-chemical characteristics. Due to this complexity, it is impossible to develop an exact copy of original drug with expired patent. Therefore, a biosimilarity concept was developed, with the comparability exercise and extrapolation of indications, using previously known approaches applied i.a. after the change of manufacturing process of the original biologic products. There are two levels of regulation of biosimilars within the EU: authorisation process is performed by European Medicines Agency, while pricing, reimbursement, prescribing and interchangeability are dealt on national level. Guidelines setting up the criteria for possibilities of extrapolation and critical qualitative criteria for the comparability exercise are important parts of the authorisation regulation and processes. After the initial reservations, the concept of extrapolations is now being accepted by the professional healthcare community more widely. In any case, pharmacists should play a key role in education, counselling and medicines optimisation processes in area of biologics.
- MeSH
- Biosimilar Pharmaceuticals * therapeutic use MeSH
- Pharmaceutical Services standards MeSH
- Humans MeSH
- Drug Substitution economics standards trends MeSH
- Drug Approval organization & administration legislation & jurisprudence MeSH
- Legislation, Drug MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
