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Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/N...

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Detalles Bibliográficos
Autores principales: Andrade, E.L., Bento, A.F., Cavalli, J., Oliveira, S.K., Schwanke, R.C., Siqueira, J.M., Freitas, C.S., Marcon, R., Calixto, J.B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Associação Brasileira de Divulgação Científica 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5188860/
https://www.ncbi.nlm.nih.gov/pubmed/27982281
http://dx.doi.org/10.1590/1414-431X20165646