Bioequivalence study of two subcutaneous formulations of dalteparin: randomized, single-dose, two-sequence, two-period, cross-over study in healthy volunteers

OBJECTIVE: This study assessed relative bioavailability of a new subcutaneous formulation, test (T) (dalteparin sodium 95000 IU/3.8 mL) with the branded product (R) in healthy subjects to meet the regulatory requirements of bioequivalence in the US. METHODS: This was an open label, randomized, singl...

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Detalhes bibliográficos
Publicado no:J Drug Assess
Main Authors: Gadiko, C., Tippabhotla, S. K., Thota, S., Nakkawar, M., Cheerla, R., Betha, M.R., Vobalaboina, V.
Formato: Artigo
Idioma:Inglês
Publicado em: Maney Publishing 2013
Assuntos:
Original Articles
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4937650/
https://ncbi.nlm.nih.gov/pubmed/27536434
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3109/21556660.2013.781504
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