Systemic Exposure Pharmaceuticals / ICH Expert Working Group / Carcinogenicity Studies For pharmaceuticals / /
Continent
Europe / /
Country
Japan / United States / /
Event
Product Issues / FDA Phase / /
IndustryTerm
chemical synthesis / similar products / pharmaceuticals / pharmaceutical / treatment of advanced systemic disease / biotechnology products / certain delivery systems / pharmaceutical research / /
MedicalCondition
secondary cancers / cancer / severely debilitating diseases / chronic toxicity study / allergic rhinitis / certain serious diseases / depression / tumour / advanced systemic disease / /
MedicalTreatment
alternative therapy / adjuvant therapy / /
Organization
European Union / US Food and Drug Administration / /
THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY