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doi: 10.1016/s0168-8278(03)00380-5

Krieg, P
For a detailed discussion of the criteria for substantial similarity, we refer readers to the FY 2006 IPPS final rule (70 FR 47351 through 47352) and the FY 2010 IPPS/LTCH PPS final rule (74 FR 43813 through 43814)
Beyond BBB penetration, the selection of DDS in AD should also consider disease-specific pathological features that may affect therapeutic access and efficacy
Toma KG, Rebbapragada I, Durand S, Lykke-Andersen J