Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design

• Autores: Haibiao Jiang, Jingjing Zhang
• Localización: European journal of psychiatry, ISSN 0213-6163, Vol. 30, Nº 1, 2016, págs. 29-40
• Idioma: inglés
• Enlaces
  • Texto completo (pdf)
• Referencias bibliográficas
  • Guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia. EMA/CHMP/40072/2010...
  • Chow SC. In Chow SC, Chang M (editors). Adaptive Design methods in clinical trials. Boca Raton, Florida: Chapman & Hall /CRC. 2007: 78-87.
  • Study of LY2140023 in Schizophrenia (NCT00149292). https://www.clinicaltrials.gov/ct2/show/NCT00149292
  • Efficacy and Safety of Asenapine With Placebo and Haloperidol (NCT00156104). https://www.clinicaltrials.gov/ct2/show/NCT00156104
  • Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact...