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European Union pharmacovigilance capabilities: potential for the new legislation.

Therapeutic advances in drug safety

Borg JJ, Tanti A, Kouvelas D, Lungu C, Pirozynski M, Serracino-Inglott A, Aislaitner G.
PMID: 26301067
Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802.

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of...

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Borg JJ, Tanti A, Kouvelas D, et al. European Union pharmacovigilance capabilities: potential for the new legislation. Ther Adv Drug Saf. 2015;6(4):120-40doi: 10.1177/2042098615591802.
Borg, J. J., Tanti, A., Kouvelas, D., Lungu, C., Pirozynski, M., Serracino-Inglott, A., & Aislaitner, G. (2015). European Union pharmacovigilance capabilities: potential for the new legislation. Therapeutic advances in drug safety, 6(4), 120-40. https://doi.org/10.1177/2042098615591802
Borg, John Joseph, et al. "European Union pharmacovigilance capabilities: potential for the new legislation." Therapeutic advances in drug safety vol. 6,4 (2015): 120-40. doi: https://doi.org/10.1177/2042098615591802
Borg JJ, Tanti A, Kouvelas D, Lungu C, Pirozynski M, Serracino-Inglott A, Aislaitner G. European Union pharmacovigilance capabilities: potential for the new legislation. Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802. PMID: 26301067; PMCID: PMC4530350.
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A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.

Molecular psychiatry

Sforzini L, Worrell C, Kose M, Anderson IM, Aouizerate B, Arolt V, Bauer M, Baune BT, Blier P, Cleare AJ, Cowen PJ, Dinan TG, Fagiolini A, Ferrier IN, Hegerl U, Krystal AD, Leboyer M, McAllister-Williams RH, McIntyre RS, Meyer-Lindenberg A, Miller AH, Nemeroff CB, Normann C, Nutt D, Pallanti S, Pani L, Penninx BWJH, Schatzberg AF, Shelton RC, Yatham LN, Young AH, Zahn R, Aislaitner G, Butlen-Ducuing F, Fletcher C, Haberkamp M, Laughren T, Mäntylä FL, Schruers K, Thomson A, Arteaga-Henríquez G, Benedetti F, Cash-Gibson L, Chae WR, De Smedt H, Gold SM, Hoogendijk WJG, Mondragón VJ, Maron E, Martynowicz J, Melloni E, Otte C, Perez-Fuentes G, Poletti S, Schmidt ME, van de Ketterij E, Woo K, Flossbach Y, Ramos-Quiroga JA, Savitz AJ, Pariante CM.
PMID: 34907394
Mol Psychiatry. 2021 Dec 15; doi: 10.1038/s41380-021-01381-x. Epub 2021 Dec 15.

Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve...

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Sforzini L, Worrell C, Kose M, et al. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Mol Psychiatry. 2021;doi: 10.1038/s41380-021-01381-x.
Sforzini, L., Worrell, C., Kose, M., Anderson, I. M., Aouizerate, B., Arolt, V., Bauer, M., Baune, B. T., Blier, P., Cleare, A. J., Cowen, P. J., Dinan, T. G., Fagiolini, A., Ferrier, I. N., Hegerl, U., Krystal, A. D., Leboyer, M., McAllister-Williams, R. H., McIntyre, R. S., Meyer-Lindenberg, A., Miller, A. H., Nemeroff, C. B., Normann, C., Nutt, D., Pallanti, S., Pani, L., Penninx, B. W. J. H., Schatzberg, A. F., Shelton, R. C., Yatham, L. N., Young, A. H., Zahn, R., Aislaitner, G., Butlen-Ducuing, F., Fletcher, C., Haberkamp, M., Laughren, T., Mäntylä, F. L., Schruers, K., Thomson, A., Arteaga-Henríquez, G., Benedetti, F., Cash-Gibson, L., Chae, W. R., De Smedt, H., Gold, S. M., Hoogendijk, W. J. G., Mondragón, V. J., Maron, E., Martynowicz, J., Melloni, E., Otte, C., Perez-Fuentes, G., Poletti, S., Schmidt, M. E., van de Ketterij, E., Woo, K., Flossbach, Y., Ramos-Quiroga, J. A., Savitz, A. J., & Pariante, C. M. (2021). A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Molecular psychiatry, . https://doi.org/10.1038/s41380-021-01381-x
Sforzini, Luca, et al. "A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials." Molecular psychiatry vol. (2021). doi: https://doi.org/10.1038/s41380-021-01381-x
Sforzini L, Worrell C, Kose M, Anderson IM, Aouizerate B, Arolt V, Bauer M, Baune BT, Blier P, Cleare AJ, Cowen PJ, Dinan TG, Fagiolini A, Ferrier IN, Hegerl U, Krystal AD, Leboyer M, McAllister-Williams RH, McIntyre RS, Meyer-Lindenberg A, Miller AH, Nemeroff CB, Normann C, Nutt D, Pallanti S, Pani L, Penninx BWJH, Schatzberg AF, Shelton RC, Yatham LN, Young AH, Zahn R, Aislaitner G, Butlen-Ducuing F, Fletcher C, Haberkamp M, Laughren T, Mäntylä FL, Schruers K, Thomson A, Arteaga-Henríquez G, Benedetti F, Cash-Gibson L, Chae WR, De Smedt H, Gold SM, Hoogendijk WJG, Mondragón VJ, Maron E, Martynowicz J, Melloni E, Otte C, Perez-Fuentes G, Poletti S, Schmidt ME, van de Ketterij E, Woo K, Flossbach Y, Ramos-Quiroga JA, Savitz AJ, Pariante CM. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Mol Psychiatry. 2021 Dec 15; doi: 10.1038/s41380-021-01381-x. Epub 2021 Dec 15. PMID: 34907394.
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Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

Scientia pharmaceutica

Borg JJ, Tomasi P, Pani L, Aislaitner G, Pirozynski M, Leufkens H, Melchiorri D.
PMID: 26171329
Sci Pharm. 2014 May 22;82(4):847-56. doi: 10.3797/scipharm.1312-10. Print 2014.

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on...

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Borg JJ, Tomasi P, Pani L, et al. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective. Sci Pharm. 2014;82(4):847-56doi: 10.3797/scipharm.1312-10.
Borg, J. J., Tomasi, P., Pani, L., Aislaitner, G., Pirozynski, M., Leufkens, H., & Melchiorri, D. (2014). Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective. Scientia pharmaceutica, 82(4), 847-56. https://doi.org/10.3797/scipharm.1312-10
Borg, John Joseph, et al. "Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective." Scientia pharmaceutica vol. 82,4 (2014): 847-56. doi: https://doi.org/10.3797/scipharm.1312-10
Borg JJ, Tomasi P, Pani L, Aislaitner G, Pirozynski M, Leufkens H, Melchiorri D. Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective. Sci Pharm. 2014 May 22;82(4):847-56. doi: 10.3797/scipharm.1312-10. Print 2014. PMID: 26171329; PMCID: PMC4475802.
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Showing 1 to 3 of 3 entries