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Le Spécialiste de Synthèse by Derra, Abdoul Hamid

Le Spécialiste de Synthèse

by Abdoul Hamid Derra
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Book cover type: Paperback
  • ISBN13: 9786206734307
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Editions Universitaires Europeennes
  • Publisher Imprint: Editions Universitaires Europeennes
  • Publication Date:
  • Pages: 328
  • Original Price: GBP 81.0
  • Language: French
  • Edition: N/A
  • Item Weight: 440 grams
  • BISAC Subject(s): General

La fabrication des substances actives et des m�dicaments biologiques implique certaines consid�rations sp�cifiques dict�es par la nature de ces produits et par les proc�d�s utilis�s. Les m�thodes selon lesquelles sont fabriqu�s, contr�l�s et administr�s les m�dicaments biologiques rendent n�cessaires certaines pr�cautions particuli�res. � la diff�rence des m�dicaments classiques, qui sont fabriqu�s au moyen de techniques physiques et chimiques capables d'un haut degr� de reproductibilit�, la fabrication des substances actives et des m�dicaments biologiques implique des proc�d�s et mati�res biologiques tels que la culture de cellules ou l'extraction � partir d'organismes vivants. Ces proc�d�s biologiques peuvent pr�senter une variabilit� inh�rente, de sorte que la gamme et la nature des sous-produits peuvent varier. Les principes de gestion du risque qualit� (quality risk management, QRM) sont donc particuli�rement importants pour cette classe de mati�res, et doivent �tre appliques afin de d�velopper une strat�gie de contr�le durant toutes les �tapes de la fabrication, de fa�on � minimiser la variabilit� et � r�duire le risque de contamination et de contamination crois�e.

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