Table 1.

Exemplative comparison of potential considerations for pediatric medicine, pharmaceutical development, and supply requirements for high income economies compared to low- and middle-income economies.

Property	Traditional Pharma Drug Development	Global Health Drug Development	Impact on Development Opportunities for Low Resource Settings
Target population	0–18 years	0–18 years	None
Excipients (safety)	Acceptable for proposed patients	Acceptable for proposed patients	None
Acceptability	Palatable, non-irritant	Palatable, non-irritant	Minimal. Potential cultural differences (e.g., flavors) may need to be considered
Dose preparation	Minimal manipulation/preparation, oral products may be mixed with water/food/beverage	Minimal manipulation, preferably no preparation	Avoid requirement for mixing if possible. If required, consider readily available vehicles, e.g., breast milk
Administration	Easy to administer, use of administration device if necessary	Easy to administer, preferably no administration device needed	Consider alternative options for dosing (no device)
Storage conditions	25 °C–30 °C/60–65% RH, refrigerated accepted (2–8 °C)	30 °C/75% RH	Ready to use liquids and semi-solids less favorable
Packaging	Various, no restrictions	Compact, light in weight, robust	Select light/compact container closure (preferably not glass)
Cost	Low overall cost ideal but not necessary	Low – standard non-complex manufacturing with low cost raw materials	Select only routine processes and commonly available, non-specialist, low cost excipients
Supply chain	Generally well-developed and efficient	Poorly developed and fragmented	Longer shelf life may be required, robust packaging
Regulatory	Mature and well-recognized regulatory requirements	Disparate regulatory requirements	Tailor regulatory strategy to each country/market