| Reviewing non clinical data for a granulocyte colony stimulatory factor product: Experience in Brazil. | |
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MedLine Citation:
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PMID: 21784651 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Non clinical studies are one of the requirements for the Brazilian National Regulatory Authority, ANVISA, for licensing a similar biotherapeutic product. During the WHO/KFDA workshop on implementing WHO guidelines on evaluating similar biotherapeutic products (SBP) in Seoul, Republic of Korea, the Brazilian experience with the non clinical studies of a Granulocyte Colony Stimulatory Factor (G-CSF), filgrastim, was presented. The applicant presented a reduced non clinical data package, but the key studies with relevant species were conducted and the non-clinical studies were considered sufficient for approval. Using the comparability exercise, these studies were taken together with the appropriate quality and clinical packages presented. |
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Authors:
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Laura Gomes Castanheira |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-7-22 |
Journal Detail:
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Title: Biologicals : journal of the International Association of Biological Standardization Volume: - ISSN: 1095-8320 ISO Abbreviation: - Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-7-25 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9004494 Medline TA: Biologicals Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 The International Alliance for Biologicals. Published by Elsevier Ltd. All rights reserved. |
Affiliation:
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Head of Efficacy and Safety Evaluation Office, National Health Surveillance Agency (ANVISA), SIA Trecho 5, AE 57, Lote 200, Brasilia - DF, CEP 71205-050, Brazil. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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