Takaisin Tulosta

Paikallisalkuisen epilepsian hoitoon tarkoitettujen antiepileptisten lääkkeiden aikuisilla osoitetun tehon ekstrapolaatio lapsipotilaisiin

Lisätietoa aiheesta
Jarkko Kirjavainen
27.2.2020

Kirjallisuutta

  1. EMA. European Medicines Agency. Concept paper on extrapolation of efficacy and safety in medicine development. «http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129285.pdf»1 Accessed 18 Feb 2018
  2. EMA. Reflection paper on extrapolation of efficacy and safety in paediatric medicine development - Draft. «http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/04/WC500204187.pdf»2 Accessed 18 Feb 2018
  3. Pellock JM, Arzimanoglou A, D'Cruz O ym. Extrapolating evidence of antiepileptic drug efficacy in adults to children =2 years of age with focal seizures: The case for disease similarity. Epilepsia 2017;58:1686-1696 «PMID: 28755452»PubMed
  4. Arzimanoglou A, D'Cruz O, Nordli D ym. A Review of the New Antiepileptic Drugs for Focal-Onset Seizures in Pediatrics: Role of Extrapolation. Paediatr Drugs 2018;20:249-264 «PMID: 29616471»PubMed