Author:
Gupta Supriya,Alaarg Amr,Wu Zhen,Lu Xiaofeng,Garripelli VivekKumar,Dong Hanmin,Sawilla Stephanie,Patel Bhargav,Schroeder Rudolf
Publisher
Springer International Publishing
Reference87 articles.
1. Gervasi V, Dall AR, Cullen S, Mccoy T, Vucen S, Crean A. Parenteral protein formulations: an overview of approved products within the European Union. Eur J Pharm Biopharm. 2018;131:8–24.
2. Mitragotri S, Burke PA, Langer R. Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies. Nat Rev Drug Discov. 2014;13(9):655–72.
3. Geigert J. The challenge of CMC regulatory compliance for biopharmaceuticals and other biologics. 2nd ed: Springer; 2013.
4. ICH Harmonised Tripartite Guideline Q8 (R2) (2009): Pharmaceutical Development 1-18.
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
. Accessed November 26, 2018.
5. Guidance for Industry: dosage and administration section of labeling for human prescription drug and biological products — content and format.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075066.pdf
. Accessed March 1, 2019.
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献