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Search results with tag "Clinical investigation of medicinal"
ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF …
database.ich.orgClinical Investigation of Medicinal Products in the Pediatric Population 4 . of medicinal products in pediatric patients is an important goal. However, this should be done without compromising the well-being of pediatric patients participating in clinical studies. This
ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF …
www.ich.org3 ICH HARMONISED GUIDELINE ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1) ICH Consensus Guideline Released for Adoption on 18 August 2017, at Step 4 of the ICH
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE …
www.ema.europa.euexample the guideline on Pharmacokinetics in children and relevant ICH guidelines such as E11, Clinical Investigation of Medicinal Products in the Paediatric Population (CHMP/ICH/2711/99). Page 4/45 ©EMEA 2006 1. NEONATES, INFANTS AND CHILDREN 1.1 Introduction ...