Ethical and Scientific Issues in Studying the Safety of Approved Drugs

af
    m.fl.

    
    Ethical and Scientific Issues in Studying the Safety of Approved Drugs
    Du sparer Spar kr. 63,67 med Shopping-fordele
    • Leveringstid 5-10 hverdage
    • Forventet levering 03-05-2021
    For at købe bogen til fordelspris skal du have et medlemskab med Shopping-fordele. Du kan prøve medlemskabet gratis de første 30 dage. Medlemskabet fornyes automatisk og kan altid opsiges. Læs mere om medlemskaber og Shopping-fordele her.
    Format:
    Bog, paperback
    Udgivelsesdato:
    30-08-2012
    Sprog:
    Engelsk
    Sidetal:
    275
    • Beskrivelse
    • Yderligere info
    • Anmeldelser

    An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period.Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions.Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

    Andre udgaver:

    E-bog, ePub
    E-bog, PDF

    Vis mereVis mindre

    Udgivelsesdato:
    30-08-2012
    ISBN13:
    9780309218139
    Vægt:
    476 g
    Dybde:
    20 mm
    Bredde:
    152 mm
    Højde:
    229 mm
    Format:
    Paperback
    Bibliotekernes beskrivelse An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials.The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.

    Vis mereVis mindre

    Vis mereVis mindre

    Fandt du ikke hvad du søgte?

    Hvis denne bog ikke er noget for dig, kan du benytte kategorierne nedenfor til at finde andre titler. Klik på en kategori for at se lignende bøger.

    Velkommen til Saxo – din danske boghandel!

    Hos os kan du handle som gæst, Saxo-bruger eller Premium-medlem – du bestemmer helt selv. Skulle du få brug for hjælp, sidder vores kundeservice-team klar ved både telefonerne og tasterne.

    Om fordelspriser hos Saxo

    For at købe bøger til fordelspris, skal du være medlem af Premium, Premium Shopping eller Premium Studie. De første 30 dage er gratis for nye medlemmer. Medlemskabet fornyes automatisk og kan altid opsiges. Læs mere om fordelene ved vores forskellige medlemskaber her.

    Machine Name: SAXO080