An expanding horizon of complex injectable products: development and regulatory considerations-Reference-Cited by-同舟云学术

An expanding horizon of complex injectable products: development and regulatory considerations

Published:2022-08-14 Issue:2 Volume:13 Page:433-472
ISSN:2190-393X
Container-title:Drug Delivery and Translational Research
language:en
Short-container-title:Drug Deliv. and Transl. Res.

Author:

Panchal Kanan,Katke Sumeet,Dash Sanat Kumar,Gaur Ankit,Shinde Aishwarya,Saha Nithun,Mehra Neelesh Kumar,Chaurasiya Akash^ORCID

Funder

Parenteral Drug Association, India Chapter

Department of Science and Technology, Ministry of Science and Technology

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

https://link.springer.com/content/pdf/10.1007/s13346-022-01223-5.pdf

Reference191 articles.

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2. IQVIA (Human Data Science CompanyTM). Complex generics: charting a new path. Published online 2016. https://www.iqvia.com/-/media/library/white-papers/complex-generics-charting-a-new-path.pdf.

3. Lionberger RA. Innovation for generic drugs: science and research under the Generic Drug User Fee Amendments of 2012. Clin Pharmacol Ther. 2019;105(4):878–85. https://doi.org/10.1002/cpt.1364.

4. Upcoming Product-Specific Guidances for Complex Generic Drug Product Development. USFDA. https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development. Accessed 30 Sept 2021.

5. Wen H, Jung H, Li X. Drug delivery approaches in addressing clinical pharmacology-related issues: opportunities and challenges. AAPS J. 2015;17(6):1327–40. https://doi.org/10.1208/s12248-015-9814-9.

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