Referencias

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Referencias

1. Scott BJ, Klein AV, Wang J. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of cinically relevant differences and indication extrapolation. J Clin Pharmacol. 2015;55(Supl.3):S123-32.

2. World Health Organization. Guidelines on evaluation of similar biotherapeutic products. Geneva: World Health Organization; 2009.

3. FDA Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product. HHS FDA/CDER/CBER, Apr. 2015. Disponible en: https://www.fda.gov/ downloads/drugs/guidances/ucm291128.pdf

4. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnologyderived proteins as active substance: non-clinical and clinical issues, Feb. 2006 Disponble en: http://www. ema.europa.eu/docs/en_ GB/document_library/Scientific_guideline/2015/01/ WC500180219.pdf

5. European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies – nonclinical and clinical issues. May 2012. Disponible en: http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2012/06/ WC500128686.pdf

6. Ministerio de Salud y Protección Social. Decreto1782 de 2014. Fecha de consulta: 12 de junio 2018: Disponible en: https:// www.minsalud.gov.co/Normatividad.../Decreto%20 1782%20de%202014.pdf.

PATROCINADORES PRINCIPALES

  • MEDIHEALTH
  • SESDERMA
  • MD FARMACIA MAGISTRAL
  • EPIDERMIQUE
  • ISDIN
  • GALDERMA