Needle clogging of protein solutions in prefilled syringes: A two-stage process with various determinants

Author:

Scheler Stefan,Knappke Simon,Schulz Michael,Zuern Alexander

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference19 articles.

1. Modeling, design, and machine learning-based framework for optimal injectability of microparticle-based drug formulations;Sarmadi;Sci. Adv.,2020

2. Best practices for aripiprazole lauroxil administration: from formulation development to injection technique;Farwick;J. Psychiatr. Pract.,2019

3. European Medicines Agency (EMEA), 2009. Evaluation of Medicines for Human Use [Assessment Report for RoActemra], Doc. Ref.: EMEA/26276/2009, Procedure No. EMEA/H/C/000955. https://www.ema.europa.eu/en/documents/assessment-report/roactemra-epar-public-assessment-report_en.pdf (accessed 4 December 2021).

4. FDA, Center for Drug Evaluation and Research (CDER), Therapeutic Biological Establishment Evaluation Request, Application No.125472Orig1s000 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000OtherR.pdf (accessed 4 December 2021).

5. FDA, Archive for Recalls, Market Withdrawals & Safety Alerts, Company Announcement, Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection (accessed 11 May 2022).

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