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Here are some scenarios where SP studies might be waived or minimized: Locally Acting Drugs with Low Systemic Exposure: Route of Administration: If the drug is applied topically (e.g., creams, ointments, drops) or through a localized route (e.g., inhalation for lung-specific effects), and is unlikely to enter the bloodstream in significant amounts, SP studies might be waived

A Phase 3 protocol helps rebuild and protect muscle for metabolic resilience
Miladi et al., 2017)

Assists with Multiple Sclerosis

10.3389/fonc.2020.597434 197 SongX.ZhuS.ChenP.HouW.WenQ.LiuJ.et al (2018)

De D, Jamal ME, Aydemir E, Khera A
