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Health / Pharmaceutical industry / Pharmacology / Drug safety / Drug discovery / Clinical trial / Drug development / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Investigational New Drug / Clinical research / Research / Pharmaceutical sciences


CLINICAL SAFETY DATA MANAGEMENT:
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Document Date: 2012-06-22 05:13:26

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File Size: 182,32 KB

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City

Helsinki / /

Company

ICH Expert Working Group / /

Country

Japan / United States / /

Event

FDA Phase / /

IndustryTerm

classification systems / medicinal product / biological products / modified release products / pharmaceuticals / organ systems / food effects / biotechnology products / medicinal products / /

MedicalCondition

hepatic failure / mild hypertension / disease / /

MedicalTreatment

alternative therapies / radiotherapy / surgery / psychotherapy / /

Organization

European Union / Clinical Trials Institutional Review Board/Independent Ethics Committee / /

Position

investigator / General / General Considerations / /

Product

E4 / Clinical drug / /

Technology

pharmacokinetics / drug metabolism / Pharmacodynamics / biotechnology / drug development / /

SocialTag