title: Reviewing non clinical data for a granulocyte colony stimulatory factor product: experience in Brazil.
abstract: 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.
authors.affiliation: Head of Efficacy and Safety Evaluation Office, National Health Surveillance Agency (ANVISA), SIA Trecho 5, Brasilia-DF, Brazil. laura.castanheira@anvisa.gov.br
authors.forename: Laura Gomes
authors.initials: LG
authors.lastname: Castanheira
mesh_terms: D000818:Animals; D001938:Brazil; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects* / Q000494:pharmacology*; D006801:Humans; D007880:Legislation, Drug; D051381:Rats; D011994:Recombinant Proteins / Q000009:adverse effects / Q000494:pharmacology
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim