A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection
Titel:
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection
Auteur:
Nøhr, Mark Klitgaard Waheed, Shaik Rizwan Kildemoes, Rasmus Juul Hatorp, Vibeke Bækdal, Tine Aggerholm Adrian, Charlotte Lindorff Korsholm, Lars Peter Arp-Hansen, Eva Lisby Holst, Helle Roberts, Scott W.