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Il complesso genomico by Derra, Abdoul Hamid

Il complesso genomico

by Abdoul Hamid Derra
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Book cover type: Paperback
  • ISBN13: 9783330511323
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Edizioni Sapienza
  • Publisher Imprint: Edizioni Sapienza
  • Publication Date:
  • Pages: 568
  • Original Price: GBP 100.83
  • Language: Italian
  • Edition: N/A
  • Item Weight: 749 grams
  • BISAC Subject(s): Clinical Medicine

Con il termine "MTI" si intendono sia i medicinali per terapia avanzata che hanno ottenuto l'autorizzazione all'immissione in commercio, sia i medicinali per terapia avanzata che sono oggetto di sperimentazioni cliniche o utilizzati come riferimento in una sperimentazione clinica (medicinale per terapia avanzata sperimentale). Questa guida specifica i requisiti GMP che devono regolamentare la produzione di MTI che hanno ottenuto l'autorizzazione all'immissione in commercio e di MTI utilizzati nel contesto di una sperimentazione clinica. La presente guida non si applica ai farmaci diversi dagli MTI. D'altro canto, le linee guida dettagliate di cui al secondo comma dell'articolo 47 della direttiva 2001/83/ce e all'articolo 63, punto 1, del regolamento (UE) n. 536/2014 non si applicano agli MTI, a meno che non vi sia espressamente fatto riferimento nelle presenti linee guida. Se le disposizioni speciali riguardano solo i medicinali per terapie avanzate che hanno ottenuto l'autorizzazione all'immissione in commercio, il termine utilizzato � "MTI autorizzato".

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