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Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products.
Blümel M, Liu J, de Jong I, Weiser S, Fast J, Litowski J, Shuman M, Mehta SB, Amery L, Tan DCT, Jia F, Shekhawat D, Dagallier C, Emamzadeh M, Medina A, Santos C, Gasser F, Urban C. Blümel M, et al. Among authors: weiser s. J Pharm Sci. 2023 Sep;112(9):2332-2346. doi: 10.1016/j.xphs.2023.05.002. Epub 2023 May 7. J Pharm Sci. 2023. PMID: 37160227 Review.
An Industry Perspective on the Challenges of Using Closed System Transfer Devices with Biologics and Communication Guidance to Healthcare Professionals.
Gopalrathnam G, Christian TR, Jagannathan B, Petoskey F, Kühnle B, Weiser S, Kagdi R, Saluja S, Bhattacharyya A, Burton L, Zamiri C, Hanley K. Gopalrathnam G, et al. Among authors: weiser s. J Pharm Sci. 2021 Jun;110(6):2329-2335. doi: 10.1016/j.xphs.2021.02.008. Epub 2021 Feb 19. J Pharm Sci. 2021. PMID: 33617871 Review.
Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
Zamiri C, Leiske DL, Hughes PF, Kirwan JP, Der E, Cox E, Warburton R, Goss M, Weiser S, Perez-Brown J, Gopalrathnam G, Liu J, Mehta SB, Shereefa S, Specht S, Aedo SJ, Goldbach P, Jia F, Kuehnle B, Page S, Voeten L, Yi L, Zhu C. Zamiri C, et al. Among authors: weiser s. PDA J Pharm Sci Technol. 2023 Oct 17:pdajpst.2022.012806. doi: 10.5731/pdajpst.2022.012806. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37848203
322 results