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The Discriminatory Power of the BCS-Based Biowaiver: A Retrospective With Focus on Essential Medicines.
J Pharm Sci. 2019 Sep;108(9):2824-2837. doi: 10.1016/j.xphs.2019.04.030. Epub 2019 May 3.
J Pharm Sci. 2019.
PMID: 31059698
Review.
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
Hofsäss MA, Souza J, Silva-Barcellos NM, Bellavinha KR, Abrahamsson B, Cristofoletti R, Groot DW, Parr A, Langguth P, Polli JE, Shah VP, Tajiri T, Mehta MU, Dressman JB.
Hofsäss MA, et al.
J Pharm Sci. 2017 Dec;106(12):3421-3430. doi: 10.1016/j.xphs.2017.08.007. Epub 2017 Aug 24.
J Pharm Sci. 2017.
PMID: 28842299
Item in Clipboard
Solubility Determination of Active Pharmaceutical Ingredients Which Have Been Recently Added to the List of Essential Medicines in the Context of the Biopharmaceutics Classification System-Biowaiver.
Plöger GF, Hofsäss MA, Dressman JB.
Plöger GF, et al. Among authors: hofsass ma.
J Pharm Sci. 2018 Jun;107(6):1478-1488. doi: 10.1016/j.xphs.2018.01.025. Epub 2018 Feb 6.
J Pharm Sci. 2018.
PMID: 29421214
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Evaluation of Differences in Dosage Form Performance of Generics Using BCS-Based Biowaiver Specifications and Biopharmaceutical Modeling-Case Examples Amoxicillin and Doxycycline.
Hofsäss MA, Dressman J.
Hofsäss MA, et al.
J Pharm Sci. 2020 Aug;109(8):2437-2453. doi: 10.1016/j.xphs.2020.04.011. Epub 2020 Apr 24.
J Pharm Sci. 2020.
PMID: 32339527
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Suitability of the z-Factor for Dissolution Simulation of Solid Oral Dosage Forms: Potential Pitfalls and Refinements.
Hofsäss MA, Dressman J.
Hofsäss MA, et al.
J Pharm Sci. 2020 Sep;109(9):2735-2745. doi: 10.1016/j.xphs.2020.05.019. Epub 2020 Jun 1.
J Pharm Sci. 2020.
PMID: 32497594
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Differences in drug quality between South Africa and Germany.
Lehmann A, Hofsäss M, Dressman J.
Lehmann A, et al.
J Pharm Pharmacol. 2018 Oct;70(10):1301-1314. doi: 10.1111/jphp.12985. Epub 2018 Jul 25.
J Pharm Pharmacol. 2018.
PMID: 30047137
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