Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis.
- DOI
- 10.1080/14712598.2024.2376197
- Published
- 2024-07-04
- Container
- Expert Opin Biol Ther
- Publisher
- Not recorded
- Open access
- no
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Cite this work
BibTeX
@article{allodium:10.1080/14712598.2024.2376197,
title = {Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis.},
author = {Hufnagel HR and Tennyson SD.},
year = {2024},
journal = {Expert Opin Biol Ther},
doi = {10.1080/14712598.2024.2376197},
url = {https://doi.org/10.1080/14712598.2024.2376197}
}RIS
TY - JOUR TI - Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. AU - Hufnagel HR AU - Tennyson SD. PY - 2024 JO - Expert Opin Biol Ther DO - 10.1080/14712598.2024.2376197 UR - https://doi.org/10.1080/14712598.2024.2376197 ER -
APA
HR, H., & SD., T. (2024). Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis.. Expert Opin Biol Ther. https://doi.org/10.1080/14712598.2024.2376197
Source records
- europe-pmc · retrieved 2026-09-25T22:07:13.806Z