Table of Contents
Development of PK/PD Relationships: Implications for FDAMA & Pediatric Regulations
PK/PD Relationships of Antiinfective Drug Products
PK/PD Relationships of Antiinfective Drug Products and FDA Modernization Act of 1997 “FDAMA”
FDAMA, Sec. 111 Pediatric studies of drugs
Pediatric Labeling Regulations (21 CFR 201.56)
FDAMA, Sec. 112 Expediting study and approval of fast track drugs
FDAMA, Sec. 115 Clinical investigations (single clinical trial)
FDAMA, Sec. 115 Clinical investigations (single clinical trial) CONGRESSIONAL COMMITTEE REPORTS1
New Formulations and Doses of Already Approved Drugs1
Observations and Conclusions
RIDO (ECPM)
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Author: CDDS
Home Page: http://www.isap.org/past_activities.htm#ISAP/FDA workshop
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