Pediatric Pharmacology is in-depth knowledge on the effects of medicines in children came to prominence in recent years due to appreciable increase in publicly funded research and government initiatives towards providing financial incentives to industry. According to NCBI published article an independent analyses of the economic cost and return to industry of the pediatric exclusivity program showed that when research was conducted on nine drugs, the cost to industry ranged from $5 to $44 million, with a median of $12.3 million.
- Track 1-1 Approaches to pediatric studies
- Track 2-2 PK only approach
- Track 3-3 PK and PD approach
- Track 4-4 PK and efficacy approach
- Track 5-5 Safety, efficacy and potency considerations