Crommelin DJ - Search Results

1

The similarity question for biologicals and non-biological complex drugs.

Crommelin DJ, Shah VP, Klebovich I, McNeil SE, Weinstein V, Flühmann B, Mühlebach S, de Vlieger JS. Crommelin DJ, et al. Eur J Pharm Sci. 2015 Aug 30;76:10-7. doi: 10.1016/j.ejps.2015.04.010. Epub 2015 Apr 23. Eur J Pharm Sci. 2015. PMID: 25912826 Free article.

2

Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist?

Crommelin D, Bermejo T, Bissig M, Damiaans J, Krämer I, Rambourg P, Scroccaro G, Strukelj B, Tredree R, Ronco C. Crommelin D, et al. Contrib Nephrol. 2005;149:287-294. doi: 10.1159/000085690. Contrib Nephrol. 2005. PMID: 15876852 Review.

3

The pharmaceutical sciences in 2020--report of a conference organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP).

Shah VP, Besançon LJ, Stolk P, Tucker G, Crommelin DJ. Shah VP, et al. Among authors: crommelin dj. Eur J Pharm Sci. 2009 Dec 8;38(5):419-25. doi: 10.1016/j.ejps.2009.07.009. Epub 2009 Aug 3. Eur J Pharm Sci. 2009. PMID: 19651208 Free article.

4

The pharmaceutical sciences in 2020: report of a conference organized by the board of pharmaceutical sciences of the International Pharmaceutical Federation (FIP).

Shah VP, Besancon LJ, Stolk P, Tucker G, Crommelin DJ. Shah VP, et al. Among authors: crommelin dj. Pharm Res. 2010 Mar;27(3):396-9. doi: 10.1007/s11095-009-0048-3. Epub 2010 Jan 27. Pharm Res. 2010. PMID: 20107875 Free PMC article.

5

The therapeutic equivalence of complex drugs.

Schellekens H, Klinger E, Mühlebach S, Brin JF, Storm G, Crommelin DJ. Schellekens H, et al. Among authors: crommelin dj. Regul Toxicol Pharmacol. 2011 Feb;59(1):176-83. doi: 10.1016/j.yrtph.2010.09.021. Epub 2010 Oct 14. Regul Toxicol Pharmacol. 2011. PMID: 20951177

6

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Chen ML, Shah VP, Crommelin DJ, Shargel L, Bashaw D, Bhatti M, Blume H, Dressman J, Ducharme M, Fackler P, Hyslop T, Lutter L, Morais J, Ormsby E, Thomas S, Tsang YC, Velagapudi R, Yu LX. Chen ML, et al. Among authors: crommelin dj. AAPS J. 2011 Dec;13(4):556-64. doi: 10.1208/s12248-011-9294-5. Epub 2011 Aug 16. AAPS J. 2011. PMID: 21845486 Free PMC article.

7

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Chen ML, Shah VP, Crommelin DJ, Shargel L, Bashaw D, Bhatti M, Blume H, Dressman J, Ducharme M, Fackler P, Hyslop T, Lutter L, Morais J, Ormsby E, Thomas S, Tsang YC, Velagapudi R, Yu LX. Chen ML, et al. Among authors: crommelin dj. Eur J Pharm Sci. 2011 Nov 20;44(4):506-13. doi: 10.1016/j.ejps.2011.09.010. Epub 2011 Sep 16. Eur J Pharm Sci. 2011. PMID: 21946259

8

Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years.

Rowland M, Noe CR, Smith DA, Tucker GT, Crommelin DJ, Peck CC, Rocci ML Jr, Besançon L, Shah VP. Rowland M, et al. Among authors: crommelin dj. J Pharm Sci. 2012 Nov;101(11):4075-99. doi: 10.1002/jps.23295. Epub 2012 Aug 21. J Pharm Sci. 2012. PMID: 22911654

9

Different pharmaceutical products need similar terminology.

Crommelin DJ, de Vlieger JS, Weinstein V, Mühlebach S, Shah VP, Schellekens H. Crommelin DJ, et al. AAPS J. 2014 Jan;16(1):11-4. doi: 10.1208/s12248-013-9532-0. Epub 2013 Sep 25. AAPS J. 2014. PMID: 24065599 Free PMC article.

10

How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider.

Schellekens H, Stegemann S, Weinstein V, de Vlieger JS, Flühmann B, Mühlebach S, Gaspar R, Shah VP, Crommelin DJ. Schellekens H, et al. Among authors: crommelin dj. AAPS J. 2014 Jan;16(1):15-21. doi: 10.1208/s12248-013-9533-z. Epub 2013 Sep 25. AAPS J. 2014. PMID: 24065600 Free PMC article. Review.

11

Theme issue 5th World Conference on Drug Absorption, Transport and Delivery.

Lennernäs H, Langguth P, Yamashita S, Crommelin DJ. Lennernäs H, et al. Among authors: crommelin dj. Eur J Pharm Sci. 2014 Sep 30;61:1. doi: 10.1016/j.ejps.2014.05.013. Eur J Pharm Sci. 2014. PMID: 24929622 No abstract available.

12

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. 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

13

How to select a nanosimilar.

Astier A, Barton Pai A, Bissig M, Crommelin DJA, Flühmann B, Hecq JD, Knoeff J, Lipp HP, Morell-Baladrón A, Mühlebach S. Astier A, et al. Ann N Y Acad Sci. 2017 Nov;1407(1):50-62. doi: 10.1111/nyas.13382. Epub 2017 Jul 17. Ann N Y Acad Sci. 2017. PMID: 28715605 Free article.

14

The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations.

Klein K, Stolk P, De Bruin ML, Leufkens HGM, Crommelin DJA, De Vlieger JSB. Klein K, et al. Eur J Pharm Sci. 2019 May 15;133:228-235. doi: 10.1016/j.ejps.2019.03.029. Epub 2019 Apr 3. Eur J Pharm Sci. 2019. PMID: 30953753 Free article. Review.

15

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".

de Vlieger JSB, Crommelin DJA, Tyner K, Drummond DC, Jiang W, McNeil SE, Neervannan S, Crist RM, Shah VP. de Vlieger JSB, et al. AAPS J. 2019 Apr 17;21(4):56. doi: 10.1208/s12248-019-0329-7. AAPS J. 2019. PMID: 30997588 Free PMC article.

16

Editorial: Public-Private Partnerships as Drivers of Innovation in Healthcare.

de Vrueh RLA, de Vlieger JSB, Crommelin DJA. de Vrueh RLA, et al. Front Med (Lausanne). 2019 May 31;6:114. doi: 10.3389/fmed.2019.00114. eCollection 2019. Front Med (Lausanne). 2019. PMID: 31214590 Free PMC article. No abstract available.

17

Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences.

Crommelin DJA, Mastrobattista E, Hawe A, Hoogendoorn KH, Jiskoot W. Crommelin DJA, et al. J Pharm Sci. 2020 Jan;109(1):30-43. doi: 10.1016/j.xphs.2019.08.010. Epub 2019 Aug 23. J Pharm Sci. 2020. PMID: 31449815 Review.

18

Dissolution rate of griseofulvin in bile salt solutions.

de Smidt JH, Offringa JC, Crommelin DJ. de Smidt JH, et al. Among authors: crommelin dj. J Pharm Sci. 1991 Apr;80(4):399-401. doi: 10.1002/jps.2600800424. J Pharm Sci. 1991. PMID: 1865343

19

Intestinal absorption of drugs. I: The influence of taurocholate on the absorption of dantrolene in the small intestine of the rat.

Poelma FG, Tukker JJ, Crommelin DJ. Poelma FG, et al. Among authors: crommelin dj. J Pharm Sci. 1989 Apr;78(4):285-9. doi: 10.1002/jps.2600780405. J Pharm Sci. 1989. PMID: 2724091

20

Potential pitfalls in in vitro antitumor activity testing of free and liposome-entrapped doxorubicin.

Storm G, Steerenberg PA, van Borssum Waalkes M, Emmen F, Crommelin DJ. Storm G, et al. Among authors: crommelin dj. J Pharm Sci. 1988 Oct;77(10):823-30. doi: 10.1002/jps.2600771002. J Pharm Sci. 1988. PMID: 3236223

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