Wynik wyszukiwania w bazie Polska Bibliografia Lekarska GBL

Zapytanie: ARCAB
Liczba odnalezionych rekordów: 2

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Tytuł oryginału: Korzyść i ryzyko - elementy oceny leku.
Tytuł angielski: Benefit and risk - elements of medicinal product assessment.
Autorzy: Arcab Anna, Maciejczyk Agata
Źródło: Ter. Leki 2002: 52 (2) s.40-42, bibliogr. 5 poz., sum.
Sygnatura GBL: 313,514

Hasła klasyfikacyjne GBL:
  • toksykologia

    Wskaźnik treści:
  • ludzie

    Streszczenie angielskie: Medicinal products are authorised for marketing based on data from clinical trials. These investigations are planned to prove efficacy and safety. However they include only limited number of carefully chosen patients. Regulatory authorisation are supposed to assess benefit to risk ratio of drugs before granting marketing authorisation. This assessment should be performed continuously, including also post-marketing data. It is also necessary for health care professionals to make the best decision concerning proper pharmacotherapy for individual patient.


    Tytuł oryginału: Bezpieczeństwo leków - rola farmakoepidemiologii.
    Tytuł angielski: Safety of medicinal products: the role of pharmacoepidemiology.
    Autorzy: Arcab Anna, Maciejczyk Agata, Trojan Monika
    Źródło: Ter. Leki 2002: 52 (5/6) s.47-50, bibliogr. 13 poz., sum.
    Sygnatura GBL: 313,514

    Hasła klasyfikacyjne GBL:
  • farmacja

    Typ dokumentu:
  • praca epidemiologiczna

    Streszczenie angielskie: There are three parameters that medicinal products should comply with: quality, safety and efficacy. The most difficult is to get complete information concerning risk connected with drug use, especially before marketing. Data on adverse drug reactions from clinical trials are often limited. Spontaneous monitoring system is not ideal but this is the way population could benefit from healt care professional experience. In practice only 10 p.c. of health professionals report adverse drug reaction suspicion. The information get from this source sometimes leads to update of Summary of Products Characteristics or patient information leaflet or require urgent action as "Dear Doctor Letter" or even suspension or withdrawal the product from the market. In this paper some examples are given considering important safety issues during last 3 years.

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