Borchard G - Search Results

1

Nanomedicines: The magic bullets reaching their target?

Flühmann B, Ntai I, Borchard G, Simoens S, Mühlebach S. Flühmann B, et al. Among authors: borchard g. Eur J Pharm Sci. 2019 Feb 1;128:73-80. doi: 10.1016/j.ejps.2018.11.019. Epub 2018 Nov 20. Eur J Pharm Sci. 2019. PMID: 30465818 Free article. Review.

2

Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars.

Mühlebach S, Borchard G, Yildiz S. Mühlebach S, et al. Among authors: borchard g. Nanomedicine (Lond). 2015 Mar;10(4):659-74. doi: 10.2217/nnm.14.189. Nanomedicine (Lond). 2015. PMID: 25723097 Review.

3

Factors influencing safety and efficacy of intravenous iron-carbohydrate nanomedicines: From production to clinical practice.

Nikravesh N, Borchard G, Hofmann H, Philipp E, Flühmann B, Wick P. Nikravesh N, et al. Among authors: borchard g. Nanomedicine. 2020 Jun;26:102178. doi: 10.1016/j.nano.2020.102178. Epub 2020 Mar 5. Nanomedicine. 2020. PMID: 32145382 Free article. Review.

4

Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies.

Borchard G, Flühmann B, Mühlebach S. Borchard G, et al. Regul Toxicol Pharmacol. 2012 Nov;64(2):324-8. doi: 10.1016/j.yrtph.2012.08.009. Epub 2012 Aug 23. Regul Toxicol Pharmacol. 2012. PMID: 22951348

5

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.

Hussaarts L, Mühlebach S, Shah VP, McNeil S, Borchard G, Flühmann B, Weinstein V, Neervannan S, Griffiths E, Jiang W, Wolff-Holz E, Crommelin DJA, de Vlieger JSB. Hussaarts L, et al. Among authors: borchard g. Ann N Y Acad Sci. 2017 Nov;1407(1):39-49. doi: 10.1111/nyas.13347. Epub 2017 Apr 26. Ann N Y Acad Sci. 2017. PMID: 28445611

6

Nanomedicines: addressing the scientific and regulatory gap.

Tinkle S, McNeil SE, Mühlebach S, Bawa R, Borchard G, Barenholz YC, Tamarkin L, Desai N. Tinkle S, et al. Among authors: borchard g. Ann N Y Acad Sci. 2014 Apr;1313:35-56. doi: 10.1111/nyas.12403. Epub 2014 Mar 27. Ann N Y Acad Sci. 2014. PMID: 24673240

7

A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways.

Klein K, Borchard G, Shah VP, Flühmann B, McNeil SE, de Vlieger JSB. Klein K, et al. Among authors: borchard g. Ann N Y Acad Sci. 2021 Oct;1502(1):5-13. doi: 10.1111/nyas.14662. Epub 2021 Jul 22. Ann N Y Acad Sci. 2021. PMID: 34296458 Free PMC article.

8

Differences between intravenous iron products: focus on treatment of iron deficiency in chronic heart failure patients.

Martin-Malo A, Borchard G, Flühmann B, Mori C, Silverberg D, Jankowska EA. Martin-Malo A, et al. Among authors: borchard g. ESC Heart Fail. 2019 Apr;6(2):241-253. doi: 10.1002/ehf2.12400. Epub 2019 Jan 29. ESC Heart Fail. 2019. PMID: 30694615 Free PMC article. Review.

9

Nanomedicines in clinical practice: Are colloidal iron sucrose ready-to-use intravenous solutions interchangeable?

Di Francesco T, Sublet E, Borchard G. Di Francesco T, et al. Among authors: borchard g. Eur J Pharm Sci. 2019 Apr 1;131:69-74. doi: 10.1016/j.ejps.2019.02.012. Epub 2019 Feb 8. Eur J Pharm Sci. 2019. PMID: 30742979

10

Iron polymaltose complexes: Could we spot physicochemical differences in medicines sharing the same active pharmaceutical ingredient?

Di Francesco T, Delafontaine L, Philipp E, Lechat E, Borchard G. Di Francesco T, et al. Among authors: borchard g. Eur J Pharm Sci. 2020 Feb 15;143:105180. doi: 10.1016/j.ejps.2019.105180. Epub 2019 Dec 10. Eur J Pharm Sci. 2020. PMID: 31841697

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