A pharmacoeconomic comparison of monotherapy with Tegretol, Finlepsin and Trileptal (preliminary data)

Autor: Pavel P, Balabanov, Zahary I, Zahariev

Publikováno v: Folia medica. 48(2)

Pharmacoeconomics comprises a system of relatively new methods that inform policy makers about the costs and benefits of different therapies so that limited health care resources may be allocated efficiently. The purpose of this study was to perform

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::0e788de4416b1516e68185d1db2772e2
https://pubmed.ncbi.nlm.nih.gov/17408075

Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials.

Autor: Zaragoza Domingo S; Neuropsychological Research Organization s.l. (Neuropsynchro), Barcelona, Spain. Electronic address: szaragoza@psyncro.net., Alonso J; Hospital del Mar Research Institute; CIBER de Epidemiología y Salud Pública, Instituto de Salud Carlos III; Universitat Pompeu Fabra, Barcelona, Spain., Ferrer M; Hospital del Mar Research Institute; CIBER de Epidemiología y Salud Pública, Instituto de Salud Carlos III; Universitat Pompeu Fabra, Barcelona, Spain., Acosta MT; National Human Genome Research Institute (NHGRI), NIH, Washington, USA., Alphs L; Denovo Biopharma, Princeton, New Jersey, USA., Annas P; Alexion Pharmaceuticals, Inc., Copenhagen, Denmark., Balabanov P; European Medicines Agency (EMA), Amsterdam, The Netherlands., Berger AK; H. Lundbeck A/S, Copenhagen, Denmark., Bishop KI; Global Pharma Consultancy, LLC, PA, USA., Butlen-Ducuing F; European Medicines Agency, EMA, Amsterdam, The Netherlands., Dorffner G; The Siesta Group, Vienna, Austria., Edgar C; Cogstate, Ltd., London, UK., de Gracia Blanco M; Universitat de Girona, Girona, Spain., Harel B; Takeda Pharmaceuticals USA Inc, Cambridge, MA, USA., Harrison J; Scottish Brain Sciences, Scotland, UK., Horan WP; Karuna Therapeutics, Boston, MA, USA., Jaeger J; Cognitionmetrics, Stamford, CT, USA., Kottner J; Charité-Universitätsmedizin, Berlin, Germany., Pinkham A; University of Texas Southwestern Medical Center, Dallas, TX, USA., Tinoco D; Worldwide Clinical Trials, Barcelona, Spain., Vance M; Santium, Toronto, Canada., Yavorsky C; Valis Bioscience, Berkeley, CA, USA.

Publikováno v: European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology [Eur Neuropsychopharmacol] 2024 Jun; Vol. 83, pp. 32-42. Date of Electronic Publication: 2024 Apr 04.

The therapeutic potential of psychedelics: the European regulatory perspective.

Autor: Butlen-Ducuing F; European Medicines Agency, 1083 HS Amsterdam, Netherlands. Electronic address: florence.butlen@ema.europa.eu., McCulloch DE; Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark., Haberkamp M; Section Neurology, Psychiatry, Ophthalmology, Federal Institute of Drugs and Medical Devices, Bonn, Germany., Mattila T; Medicines Evaluation Board Utrecht, Netherlands., Bałkowiec-Iskra E; Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland; Urząd Rejestracji Produktów Leczniczych, Wyrobow Medycznych i Produktów Biobójczych, Warsaw, Poland., Aislaitner G; Section Neurology, Psychiatry, Ophthalmology, Federal Institute of Drugs and Medical Devices, Bonn, Germany., Balabanov P; European Medicines Agency, 1083 HS Amsterdam, Netherlands., Lundberg J; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden; European College of Neuropsychopharmacology (ECNP) Transnosological Working Group on Psychedelics, Utrecht, Netherlands., Stenbæk DS; Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; European College of Neuropsychopharmacology (ECNP) Transnosological Working Group on Psychedelics, Utrecht, Netherlands; Institute of Psychology, University of Copenhagen, Copenhagen, Denmark., Elferink A; Medicines Evaluation Board Utrecht, Netherlands., Knudsen GM; Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; European College of Neuropsychopharmacology (ECNP) Transnosological Working Group on Psychedelics, Utrecht, Netherlands; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Thirstrup S; European Medicines Agency, 1083 HS Amsterdam, Netherlands.

Publikováno v: Lancet (London, England) [Lancet] 2023 Mar 04; Vol. 401 (10378), pp. 714-716. Date of Electronic Publication: 2023 Feb 10.

Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective.

Autor: Mantua V, Arango C, Balabanov P, Butlen-Ducuing F

Publikováno v: Nature reviews. Drug discovery [Nat Rev Drug Discov] 2021 Feb; Vol. 20 (2), pp. 83-84.

Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions.

Autor: Sheean ME; Max-Delbrueck Center for Translational Medicine in the Helmholtz Association, Berlin, Germany; European Medicines Agency, London, UK. Electronic address: maria.sheean@ema.europa.eu., Stoyanova-Beninska V; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; College ter Beoordeling van Geneesmiddelen, Utrecht, The Netherlands., Capovilla G; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; Child Neuropsychiatry Department, Epilepsy Center, Mantova, Italy., Duarte D; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal., Hofer MP; European Medicines Agency, London, UK., Hoffmann M; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; Centre Hospitalier du Nord Ettelbruck, Ettelbruck, Luxembourg., Magrelli A; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy., Mariz S; European Medicines Agency, London, UK., Tsigkos S; European Medicines Agency, London, UK., Shaili E; European Medicines Agency, London, UK., Polsinelli B; European Medicines Agency, London, UK., Ricciardi M; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; Cystic Fibrosis Europe, Brussels, Belgium., Bonelli M; European Medicines Agency, London, UK., Balabanov P; European Medicines Agency, London, UK., Larsson K; European Medicines Agency, London, UK., Sepodes B; Committee of Orphan Medicinal Products, European Medicines Agency, London, UK; Universidade de Lisboa, Faculdade de Farmácia, Lisbon, Portugal.

Publikováno v: Drug discovery today [Drug Discov Today] 2018 Jan; Vol. 23 (1), pp. 26-48. Date of Electronic Publication: 2017 Oct 04.