Wissenschaftliche Verlagsgesellschaft Stuttgart
Wissenschaftliche Verlagsgesellschaft Stuttgart

Klinische Prüfung

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McGraw, Michael J (Ed.) / Shearn, Shawn P (Ed.) / Hall, Rigel L (Ed.) / Haws, Thomas F (Ed.) / George, Adam N (Ed.)

Principles of Good Clinical Practice

Artikel-Nr 180046006


Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights.

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape.

    1. Introduction
    2. Regulatory Requirements
    3. Informed consent
    4. Investigator responsibilities
    5. Sponsor responsibilities
    6. Clinical trial design
    7. Site monitoring
    8. Institutional Review Boards and Independent Ethics Committees
    9. Pharmacovigilance
    10. Clinical trial registration and reporting
    11. Quality Assurence
    12. Future implications of good clinical practices

256 p.
soft cover

Deutscher Apotheker Verlag


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Neuerscheinungen Pharmazie

Kieser, Timo / Buckstegge, Svenja
Pflichtschulung Datenschutz
nach § 39 Abs. I DSGVO


American Society of Health-System Pharmacists, ASHP (Ed.)
AHFS Drug Information 2018
American Hospital Formulary Service Drug Information


Pachaly, Peter / Koch, Angelika (Bearb.)
Dünnschichtchromatographie in der Apotheke


Saatz, Julia
Vergiftungsfälle in Wissenschaft, Justiz und Öffentlichkeit
Giftnarrative zwischen 1750 und 1850