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How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study
BACKGROUND: Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performa...
Autores principales: | Berger, M., Kooyman, P. J., Makkee, M., van der Zee, J. S., Sterk, P. J., van Dijk, J., Kemper, E. M. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4992213/ https://www.ncbi.nlm.nih.gov/pubmed/27542842 http://dx.doi.org/10.1186/s12931-016-0413-9 |
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