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Ghaderkhani J, Yousefimashouf R, Arabestani M, Roshanaei G, Asl SS, Abbasalipourkabir R

Overall, DZN exposure may disrupt reproductive efficiency in zebrafish

Regulatory Considerations and the 505(b)(2) Pathway Because ibutamoren has extensive published human pharmacology data (over 1,000 subjects dosed across Merck's program), a future sponsor could potentially file a 505(b)(2) application referencing existing literature rather than conducting full Phase I-III development 19

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Healthcare professionals can then assess whether symptoms represent expected therapeutic effects, require symptomatic management, or indicate a need to modify the treatment regimen