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The following is a list of all entries tagged with Follow-up:
EMA, the European Drug Regulator Publishes Reflection paper on Quality, Non-Clinical and Clinical Issues related to the Development of Recombinant Adeno-Associated Viral Vectors
Filed in clinical,manufacturing,pre-clinical, July 19, 2010, 9:22 amRecombinant adeno-associated viral (rAAV) vectors are derived from the single stranded DNA virus adeno-associated virus which belongs to the genus dependovirus within the Parvoviridae family. As the name suggests the wild type virus is incapable of independent replication and relies on co-infection of a helper virus to enable a lytic replication cycle (Gonclaves, 2005). Adenovirus (Ad), herpes simplex virus (HSV), pseudorabies virus (PrV) and human papilloma virus (HPV) are known to support wild type AAV replication.
Drug Regulators, EMEA, CHMP Publish Guidance on Follow-up Patients Adminstered with Gene Therapy Medical Products
Filed in biotechnology,clinical,regulatory, December 16, 2009, 11:25 amThe initial clinical monitoring and follow-up after treatment with Gene Therapy (GT) medicinal products is described in the CPMP Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products (CPMP/BWP/3088/99).
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