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3.9.4 Ustekinumab Ustekinumab, an IL-12/23 inhibitor, is a second-line therapy for HS and should be used with caution in pregnancy and lactation

Considerations of Excipient-Transporter Interaction M9 guidance requires a BCS-based biowaiver proposal to include a mechanistic and risk-based approach in assessing if differences between test and reference product (e.g

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