A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection. - Nøhr MK; Waheed SR; Kildemoes RJ; Hatorp V; Bækdal TA; Adrian CL; Korsholm LP; Arp-Hansen EL; Holst H; Roberts SW (The AAPS journal, 2024)