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FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines.

Frontiers in pharmacology

Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H.
PMID: 28420989
Front Pharmacol. 2017 Apr 03;8:161. doi: 10.3389/fphar.2017.00161. eCollection 2017.

The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine...

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Liberti L, Bujar M, Breckenridge A, et al. FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Front Pharmacol. 2017;8:161doi: 10.3389/fphar.2017.00161.
Liberti, L., Bujar, M., Breckenridge, A., Hoekman, J., McAuslane, N., Stolk, P., & Leufkens, H. (2017). FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Frontiers in pharmacology, 8161. https://doi.org/10.3389/fphar.2017.00161
Liberti, Lawrence, et al. "FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines." Frontiers in pharmacology vol. 8 (2017): 161. doi: https://doi.org/10.3389/fphar.2017.00161
Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines. Front Pharmacol. 2017 Apr 03;8:161. doi: 10.3389/fphar.2017.00161. eCollection 2017. PMID: 28420989; PMCID: PMC5376616.
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The synthesis and characterization of 1 1 1 1 type diluted ferromagnetic semiconductor (La(1-x)Ca(x))(Zn(1-x) Mn(x))AsO.

Journal of physics. Condensed matter : an Institute of Physics journal

Ding C, Guo S, Zhao Y, Man H, Fu L, Gu Y, Wang Z, Liu L, Frandsen BA, Cheung S, Uemura YJ, Goko T, Luetkens H, Morenzoni E, Zhao Y, Ning FL.
PMID: 26679223
J Phys Condens Matter. 2016 Jan 20;28(2):026003. doi: 10.1088/0953-8984/28/2/026003. Epub 2015 Dec 18.

We report the synthesis and characterization of a bulk form diluted magnetic semiconductor, (La(1-x)Ca(x))(Zn(1-y) Mn(y))AsO, with a layered crystal structure isostructural to that of the 1 1 1 1 type Fe-based high-temperature superconductor LaFeAsO and the antiferromagnetic LaMnAsO. With...

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Ding C, Guo S, Zhao Y, et al. The synthesis and characterization of 1 1 1 1 type diluted ferromagnetic semiconductor (La(1-x)Ca(x))(Zn(1-x) Mn(x))AsO. J Phys Condens Matter. 2015;28(2):026003doi: 10.1088/0953-8984/28/2/026003.
Ding, C., Guo, S., Zhao, Y., Man, H., Fu, L., Gu, Y., Wang, Z., Liu, L., Frandsen, B. A., Cheung, S., Uemura, Y. J., Goko, T., Luetkens, H., Morenzoni, E., Zhao, Y., & Ning, F. L. (2016). The synthesis and characterization of 1 1 1 1 type diluted ferromagnetic semiconductor (La(1-x)Ca(x))(Zn(1-x) Mn(x))AsO. Journal of physics. Condensed matter : an Institute of Physics journal, 28(2), 026003. https://doi.org/10.1088/0953-8984/28/2/026003
Ding, Cui, et al. "The synthesis and characterization of 1 1 1 1 type diluted ferromagnetic semiconductor (La(1-x)Ca(x))(Zn(1-x) Mn(x))AsO." Journal of physics. Condensed matter : an Institute of Physics journal vol. 28,2 (2016): 026003. doi: https://doi.org/10.1088/0953-8984/28/2/026003
Ding C, Guo S, Zhao Y, Man H, Fu L, Gu Y, Wang Z, Liu L, Frandsen BA, Cheung S, Uemura YJ, Goko T, Luetkens H, Morenzoni E, Zhao Y, Ning FL. The synthesis and characterization of 1 1 1 1 type diluted ferromagnetic semiconductor (La(1-x)Ca(x))(Zn(1-x) Mn(x))AsO. J Phys Condens Matter. 2016 Jan 20;28(2):026003. doi: 10.1088/0953-8984/28/2/026003. Epub 2015 Dec 18. PMID: 26679223.
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Correction to: Age Neutrality of Categorically and Dimensionally Measured DSM-5 Section II Personality Disorder Symptoms.

Journal of personality assessment

Debast I, Rossi G, van Alphen SP, Pauwels E, Claes L, Dierckx E, Peuskens H, Santens E, Schotte CK.
PMID: 26186505
J Pers Assess. 2015;97(6):661. doi: 10.1080/00223891.2015.1059662. Epub 2015 Jul 17.

No abstract available.

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Debast I, Rossi G, van Alphen SP, et al. Correction to: Age Neutrality of Categorically and Dimensionally Measured DSM-5 Section II Personality Disorder Symptoms. J Pers Assess. 2015;97(6):661doi: 10.1080/00223891.2015.1059662.
Debast, I., Rossi, G., van Alphen, S. P., Pauwels, E., Claes, L., Dierckx, E., Peuskens, H., Santens, E., & Schotte, C. K. (2015). Correction to: Age Neutrality of Categorically and Dimensionally Measured DSM-5 Section II Personality Disorder Symptoms. Journal of personality assessment, 97(6), 661. https://doi.org/10.1080/00223891.2015.1059662
Debast, Inge, et al. "Correction to: Age Neutrality of Categorically and Dimensionally Measured DSM-5 Section II Personality Disorder Symptoms." Journal of personality assessment vol. 97,6 (2015): 661. doi: https://doi.org/10.1080/00223891.2015.1059662
Debast I, Rossi G, van Alphen SP, Pauwels E, Claes L, Dierckx E, Peuskens H, Santens E, Schotte CK. Correction to: Age Neutrality of Categorically and Dimensionally Measured DSM-5 Section II Personality Disorder Symptoms. J Pers Assess. 2015;97(6):661. doi: 10.1080/00223891.2015.1059662. Epub 2015 Jul 17. PMID: 26186505.
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Field and temperature dependence of the superfluid density in LaFeAsO1-xFx superconductors: a muon spin relaxation study.

Physical review letters

Luetkens H, Klauss HH, Khasanov R, Amato A, Klingeler R, Hellmann I, Leps N, Kondrat A, Hess C, Köhler A, Behr G, Werner J, Büchner B.
PMID: 18851647
Phys Rev Lett. 2008 Aug 29;101(9):097009. doi: 10.1103/PhysRevLett.101.097009. Epub 2008 Aug 29.

We present zero field and transverse field muon spin relaxation experiments on the recently discovered Fe-based superconductor LaFeAsO1-xFx (x=0.075 and x=0.1). The temperature dependence of the deduced superfluid density is consistent with a BCS s-wave or a dirty d-wave...

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Luetkens H, Klauss HH, Khasanov R, et al. Field and temperature dependence of the superfluid density in LaFeAsO1-xFx superconductors: a muon spin relaxation study. Phys Rev Lett. 2008;101(9):097009doi: 10.1103/PhysRevLett.101.097009.
Luetkens, H., Klauss, H. H., Khasanov, R., Amato, A., Klingeler, R., Hellmann, I., Leps, N., Kondrat, A., Hess, C., Köhler, A., Behr, G., Werner, J., & Büchner, B. (2008). Field and temperature dependence of the superfluid density in LaFeAsO1-xFx superconductors: a muon spin relaxation study. Physical review letters, 101(9), 097009. https://doi.org/10.1103/PhysRevLett.101.097009
Luetkens, H, et al. "Field and temperature dependence of the superfluid density in LaFeAsO1-xFx superconductors: a muon spin relaxation study." Physical review letters vol. 101,9 (2008): 097009. doi: https://doi.org/10.1103/PhysRevLett.101.097009
Luetkens H, Klauss HH, Khasanov R, Amato A, Klingeler R, Hellmann I, Leps N, Kondrat A, Hess C, Köhler A, Behr G, Werner J, Büchner B. Field and temperature dependence of the superfluid density in LaFeAsO1-xFx superconductors: a muon spin relaxation study. Phys Rev Lett. 2008 Aug 29;101(9):097009. doi: 10.1103/PhysRevLett.101.097009. Epub 2008 Aug 29. PMID: 18851647.
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Commensurate spin density wave in LaFeAsO: a local probe study.

Physical review letters

Klauss HH, Luetkens H, Klingeler R, Hess C, Litterst FJ, Kraken M, Korshunov MM, Eremin I, Drechsler SL, Khasanov R, Amato A, Hamann-Borrero J, Leps N, Kondrat A, Behr G, Werner J, Büchner B.
PMID: 18764570
Phys Rev Lett. 2008 Aug 15;101(7):077005. doi: 10.1103/PhysRevLett.101.077005. Epub 2008 Aug 14.

We present a detailed study on the magnetic order in the undoped mother compound LaFeAsO of the recently discovered Fe-based superconductor LaFeAsO1-xFx. In particular, we present local probe measurements of the magnetic properties of LaFeAsO by means of 57Fe...

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Klauss HH, Luetkens H, Klingeler R, et al. Commensurate spin density wave in LaFeAsO: a local probe study. Phys Rev Lett. 2008;101(7):077005doi: 10.1103/PhysRevLett.101.077005.
Klauss, H. H., Luetkens, H., Klingeler, R., Hess, C., Litterst, F. J., Kraken, M., Korshunov, M. M., Eremin, I., Drechsler, S. L., Khasanov, R., Amato, A., Hamann-Borrero, J., Leps, N., Kondrat, A., Behr, G., Werner, J., & Büchner, B. (2008). Commensurate spin density wave in LaFeAsO: a local probe study. Physical review letters, 101(7), 077005. https://doi.org/10.1103/PhysRevLett.101.077005
Klauss, H-H, et al. "Commensurate spin density wave in LaFeAsO: a local probe study." Physical review letters vol. 101,7 (2008): 077005. doi: https://doi.org/10.1103/PhysRevLett.101.077005
Klauss HH, Luetkens H, Klingeler R, Hess C, Litterst FJ, Kraken M, Korshunov MM, Eremin I, Drechsler SL, Khasanov R, Amato A, Hamann-Borrero J, Leps N, Kondrat A, Behr G, Werner J, Büchner B. Commensurate spin density wave in LaFeAsO: a local probe study. Phys Rev Lett. 2008 Aug 15;101(7):077005. doi: 10.1103/PhysRevLett.101.077005. Epub 2008 Aug 14. PMID: 18764570.
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Evolution of two-gap behavior of the superconductor FeSe1-x.

Physical review letters

Khasanov R, Bendele M, Amato A, Conder K, Keller H, Klauss HH, Luetkens H, Pomjakushina E.
PMID: 20366961
Phys Rev Lett. 2010 Feb 26;104(8):087004. doi: 10.1103/PhysRevLett.104.087004. Epub 2010 Feb 25.

The superfluid density, rho{s}, of the iron chalcogenide superconductor, FeSe1-x, was studied as a function of pressure by means of muon-spin rotation. The analysis of rho{s}(T) within the two-gap scheme reveals that the effect on both, the transition temperature...

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Khasanov R, Bendele M, Amato A, et al. Evolution of two-gap behavior of the superconductor FeSe1-x. Phys Rev Lett. 2010;104(8):087004doi: 10.1103/PhysRevLett.104.087004.
Khasanov, R., Bendele, M., Amato, A., Conder, K., Keller, H., Klauss, H. H., Luetkens, H., & Pomjakushina, E. (2010). Evolution of two-gap behavior of the superconductor FeSe1-x. Physical review letters, 104(8), 087004. https://doi.org/10.1103/PhysRevLett.104.087004
Khasanov, R, et al. "Evolution of two-gap behavior of the superconductor FeSe1-x." Physical review letters vol. 104,8 (2010): 087004. doi: https://doi.org/10.1103/PhysRevLett.104.087004
Khasanov R, Bendele M, Amato A, Conder K, Keller H, Klauss HH, Luetkens H, Pomjakushina E. Evolution of two-gap behavior of the superconductor FeSe1-x. Phys Rev Lett. 2010 Feb 26;104(8):087004. doi: 10.1103/PhysRevLett.104.087004. Epub 2010 Feb 25. PMID: 20366961.
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Impact of external price referencing on medicine prices - a price comparison among 14 European countries.

Southern med review

Leopold C, Mantel-Teeuwisse AK, Seyfang L, Vogler S, de Joncheere K, Laing RO, Leufkens H.
PMID: 23532710
South Med Rev. 2012 Dec;5(2):34-41. Epub 2012 Dec 27.

OBJECTIVES: This study aims to examine the impact of external price referencing (EPR) on on-patent medicine prices, adjusting for other factors that may affect price levels such as sales volume, exchange rates, gross domestic product (GDP) per capita, total...

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Leopold C, Mantel-Teeuwisse AK, Seyfang L, et al. Impact of external price referencing on medicine prices - a price comparison among 14 European countries. South Med Rev. 2012;5(2):34-41
Leopold, C., Mantel-Teeuwisse, A. K., Seyfang, L., Vogler, S., de Joncheere, K., Laing, R. O., & Leufkens, H. (2012). Impact of external price referencing on medicine prices - a price comparison among 14 European countries. Southern med review, 5(2), 34-41.
Leopold, Christine, et al. "Impact of external price referencing on medicine prices - a price comparison among 14 European countries." Southern med review vol. 5,2 (2012): 34-41.
Leopold C, Mantel-Teeuwisse AK, Seyfang L, Vogler S, de Joncheere K, Laing RO, Leufkens H. Impact of external price referencing on medicine prices - a price comparison among 14 European countries. South Med Rev. 2012 Dec;5(2):34-41. Epub 2012 Dec 27. PMID: 23532710; PMCID: PMC3606937.
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Microscopic coexistence of superconductivity and magnetism in Ba(1-x)K(x)Fe2As2.

Physical review letters

Wiesenmayer E, Luetkens H, Pascua G, Khasanov R, Amato A, Potts H, Banusch B, Klauss HH, Johrendt D.
PMID: 22182119
Phys Rev Lett. 2011 Dec 02;107(23):237001. doi: 10.1103/PhysRevLett.107.237001. Epub 2011 Nov 29.

It is widely believed that, in contrast to its electron-doped counterparts, the hole-doped compound Ba(1-x)K(x)Fe(2)As(2) exhibits a mesoscopic phase separation of magnetism and superconductivity in the underdoped region of the phase diagram. Here, we report a combined high-resolution x-ray...

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Wiesenmayer E, Luetkens H, Pascua G, et al. Microscopic coexistence of superconductivity and magnetism in Ba(1-x)K(x)Fe2As2. Phys Rev Lett. 2011;107(23):237001doi: 10.1103/PhysRevLett.107.237001.
Wiesenmayer, E., Luetkens, H., Pascua, G., Khasanov, R., Amato, A., Potts, H., Banusch, B., Klauss, H. H., & Johrendt, D. (2011). Microscopic coexistence of superconductivity and magnetism in Ba(1-x)K(x)Fe2As2. Physical review letters, 107(23), 237001. https://doi.org/10.1103/PhysRevLett.107.237001
Wiesenmayer, Erwin, et al. "Microscopic coexistence of superconductivity and magnetism in Ba(1-x)K(x)Fe2As2." Physical review letters vol. 107,23 (2011): 237001. doi: https://doi.org/10.1103/PhysRevLett.107.237001
Wiesenmayer E, Luetkens H, Pascua G, Khasanov R, Amato A, Potts H, Banusch B, Klauss HH, Johrendt D. Microscopic coexistence of superconductivity and magnetism in Ba(1-x)K(x)Fe2As2. Phys Rev Lett. 2011 Dec 02;107(23):237001. doi: 10.1103/PhysRevLett.107.237001. Epub 2011 Nov 29. PMID: 22182119.
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Structural and magnetic phase transitions in triclinic Ca10(FeAs)10(Pt3As8).

Journal of physics. Condensed matter : an Institute of Physics journal

Stürzer T, Friederichs GM, Luetkens H, Amato A, Klauss HH, Johrendt D.
PMID: 23449156
J Phys Condens Matter. 2013 Mar 27;25(12):122203. doi: 10.1088/0953-8984/25/12/122203. Epub 2013 Mar 01.

We report the structural and magnetic phase transitions of triclinic Ca10(FeAs)10(Pt3As8), which is the parent compound of the 1038-type iron-arsenide superconductors. High-resolution x-ray diffraction reveals splitting of the in-plane (a,b) lattice parameters at T(s) ≈ 120 K. Platinum-doping weakens...

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Stürzer T, Friederichs GM, Luetkens H, et al. Structural and magnetic phase transitions in triclinic Ca10(FeAs)10(Pt3As8). J Phys Condens Matter. 2013;25(12):122203doi: 10.1088/0953-8984/25/12/122203.
Stürzer, T., Friederichs, G. M., Luetkens, H., Amato, A., Klauss, H. H., & Johrendt, D. (2013). Structural and magnetic phase transitions in triclinic Ca10(FeAs)10(Pt3As8). Journal of physics. Condensed matter : an Institute of Physics journal, 25(12), 122203. https://doi.org/10.1088/0953-8984/25/12/122203
Stürzer, T, et al. "Structural and magnetic phase transitions in triclinic Ca10(FeAs)10(Pt3As8)." Journal of physics. Condensed matter : an Institute of Physics journal vol. 25,12 (2013): 122203. doi: https://doi.org/10.1088/0953-8984/25/12/122203
Stürzer T, Friederichs GM, Luetkens H, Amato A, Klauss HH, Johrendt D. Structural and magnetic phase transitions in triclinic Ca10(FeAs)10(Pt3As8). J Phys Condens Matter. 2013 Mar 27;25(12):122203. doi: 10.1088/0953-8984/25/12/122203. Epub 2013 Mar 01. PMID: 23449156.
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Singlet ground state of the quantum antiferromagnet Ba(3)CuSb(2)O(9).

Physical review letters

Quilliam JA, Bert F, Kermarrec E, Payen C, Guillot-Deudon C, Bonville P, Baines C, Luetkens H, Mendels P.
PMID: 23005669
Phys Rev Lett. 2012 Sep 14;109(11):117203. doi: 10.1103/PhysRevLett.109.117203. Epub 2012 Sep 11.

We present local probe results on the honeycomb lattice antiferromagnet Ba(3)CuSb(2)O(9). Muon spin relaxation measurements in a zero field down to 20 mK show unequivocally that there is a total absence of spin freezing in the ground state. Sb...

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Quilliam JA, Bert F, Kermarrec E, et al. Singlet ground state of the quantum antiferromagnet Ba(3)CuSb(2)O(9). Phys Rev Lett. 2012;109(11):117203doi: 10.1103/PhysRevLett.109.117203.
Quilliam, J. A., Bert, F., Kermarrec, E., Payen, C., Guillot-Deudon, C., Bonville, P., Baines, C., Luetkens, H., & Mendels, P. (2012). Singlet ground state of the quantum antiferromagnet Ba(3)CuSb(2)O(9). Physical review letters, 109(11), 117203. https://doi.org/10.1103/PhysRevLett.109.117203
Quilliam, J A, et al. "Singlet ground state of the quantum antiferromagnet Ba(3)CuSb(2)O(9)." Physical review letters vol. 109,11 (2012): 117203. doi: https://doi.org/10.1103/PhysRevLett.109.117203
Quilliam JA, Bert F, Kermarrec E, Payen C, Guillot-Deudon C, Bonville P, Baines C, Luetkens H, Mendels P. Singlet ground state of the quantum antiferromagnet Ba(3)CuSb(2)O(9). Phys Rev Lett. 2012 Sep 14;109(11):117203. doi: 10.1103/PhysRevLett.109.117203. Epub 2012 Sep 11. PMID: 23005669.
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National medicines policies - a review of the evolution and development processes.

Journal of pharmaceutical policy and practice

Hoebert JM, van Dijk L, Mantel-Teeuwisse AK, Leufkens HG, Laing RO.
PMID: 24764540
J Pharm Policy Pract. 2013 Jul 10;6:5. doi: 10.1186/2052-3211-6-5. eCollection 2013.

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these...

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Hoebert JM, van Dijk L, Mantel-Teeuwisse AK, et al. National medicines policies - a review of the evolution and development processes. J Pharm Policy Pract. 2013;6:5doi: 10.1186/2052-3211-6-5.
Hoebert, J. M., van Dijk, L., Mantel-Teeuwisse, A. K., Leufkens, H. G., & Laing, R. O. (2013). National medicines policies - a review of the evolution and development processes. Journal of pharmaceutical policy and practice, 65. https://doi.org/10.1186/2052-3211-6-5
Hoebert, Joëlle M, et al. "National medicines policies - a review of the evolution and development processes." Journal of pharmaceutical policy and practice vol. 6 (2013): 5. doi: https://doi.org/10.1186/2052-3211-6-5
Hoebert JM, van Dijk L, Mantel-Teeuwisse AK, Leufkens HG, Laing RO. National medicines policies - a review of the evolution and development processes. J Pharm Policy Pract. 2013 Jul 10;6:5. doi: 10.1186/2052-3211-6-5. eCollection 2013. PMID: 24764540; PMCID: PMC3987068.
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Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe.

Molecular therapy. Methods & clinical development

Ten Ham RMT, Hoekman J, Hövels AM, Broekmans AW, Leufkens HGM, Klungel OH.
PMID: 30456217
Mol Ther Methods Clin Dev. 2018 Oct 11;11:121-130. doi: 10.1016/j.omtm.2018.10.003. eCollection 2018 Dec 14.

Advanced therapy medicinal products (ATMPs) hold promise as treatments for previously untreatable and high-burden diseases. Expectations are high and active company pipelines are observed, yet only 10 market authorizations were approved in Europe. Our aim was to identify challenges...

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Ten Ham RMT, Hoekman J, Hövels AM, et al. Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe. Mol Ther Methods Clin Dev. 2018;11:121-130doi: 10.1016/j.omtm.2018.10.003.
Ten Ham, R. M. T., Hoekman, J., Hövels, A. M., Broekmans, A. W., Leufkens, H. G. M., & Klungel, O. H. (2018). Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe. Molecular therapy. Methods & clinical development, 11121-130. https://doi.org/10.1016/j.omtm.2018.10.003
Ten Ham, Renske M T, et al. "Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe." Molecular therapy. Methods & clinical development vol. 11 (2018): 121-130. doi: https://doi.org/10.1016/j.omtm.2018.10.003
Ten Ham RMT, Hoekman J, Hövels AM, Broekmans AW, Leufkens HGM, Klungel OH. Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe. Mol Ther Methods Clin Dev. 2018 Oct 11;11:121-130. doi: 10.1016/j.omtm.2018.10.003. eCollection 2018 Dec 14. PMID: 30456217; PMCID: PMC6234262.
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