The ICH Guideline E11 Clinical Inve...

The ICH Guideline E11 Clinical Investigation of Medicinal issues in the Pediatric Population, (1) was introduced and implemented as a Japanese pharmaceutical regulation in December 2000 Prior to the introduction of the E11 guideline, there were brace guidelines for pediatric clinical trials, the rather of advanced age Guideline for Pharmaceutical increase of Pediatric Use, (2) and a brief description in the Pediatric Application section of the General Considerations for Clinical Trials upon New Medicinal Products (3) (later replaced by means of the ICH E8 guideline). However, the ICH E11 guideline

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