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1.
Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
PDA J Pharm Sci Technol
; 2023 Oct 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-37848203
2.
An Industry Perspective on the Challenges of Using Closed System Transfer Devices with Biologics and Communication Guidance to Healthcare Professionals.
J Pharm Sci
; 110(6): 2329-2335, 2021 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-33617871
3.
A Mechanistic Understanding of Polysorbate 80 Oxidation in Histidine and Citrate Buffer Systems-Part 2.
PDA J Pharm Sci Technol
; 73(4): 320-330, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-30770486
4.
Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active Monoclonal Antibody Formulation
PDA J Pharm Sci Technol
; 72(2): 163-175, 2018.
Artículo
en Inglés
| MEDLINE | ID: mdl-29343621
5.
Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System.
PDA J Pharm Sci Technol
; 72(1): 50-61, 2018.
Artículo
en Inglés
| MEDLINE | ID: mdl-29030531
6.
Physical and chemical compatibility of drotrecogin alfa (activated) with 34 drugs during simulated Y-site administration.
Am J Health Syst Pharm
; 61(24): 2664-71, 2004 Dec 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-15646701
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