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Pharmacovigilance during the pre-approval phases : An evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines
by
HARTFORD, Craig G
,
PETCHEL, Kasia S
,
MICKAIL, Hani
,
PEREZ-GUTTHANN, Susana
,
MCHALE, Mary
,
GRANA, John M
,
MARQUEZ, Paula
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Drug safety
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