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Statistically Significant versus Practically Relevant Trend in Stability Data.
PDA J Pharm Sci Technol. 2021 Jul-Aug;75(4):341-356. doi: 10.5731/pdajpst.2020.012336. Epub 2021 Feb 19.
PDA J Pharm Sci Technol. 2021.
PMID: 33608471
Statistical Quality and Process Control in Biopharmaceutical Manufacturing-Practical Issues and Remedies.
Heigl N, Schmelzer B, Innerbichler F, Shivhare M.
Heigl N, et al. Among authors: innerbichler f.
PDA J Pharm Sci Technol. 2021 Sep-Oct;75(5):425-444. doi: 10.5731/pdajpst.2020.011676. Epub 2021 Mar 15.
PDA J Pharm Sci Technol. 2021.
PMID: 33723005
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The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal.
Mielke J, Innerbichler F, Schiestl M, Ballarini NM, Jones B.
Mielke J, et al. Among authors: innerbichler f.
AAPS J. 2018 Nov 27;21(1):7. doi: 10.1208/s12248-018-0275-9.
AAPS J. 2018.
PMID: 30483892
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