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NonClinical Dose Formulation Analysis Method Validation and Sample Analysis

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical studies. There is currently no regulatory guidance for nonclinical dose formulation analysis method val...

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Detalles Bibliográficos
Autores principales:	Whitmire, Monica Lee, Bryan, Peter, Henry, Teresa R., Holbrook, John, Lehmann, Paul, Mollitor, Thomas, Ohorodnik, Susan, Reed, David, Wietgrefe, Holly D.
Formato:	Texto
Lenguaje:	English
Publicado:	Springer US 2010
Materias:	White Paper
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2976985/ https://www.ncbi.nlm.nih.gov/pubmed/20711763 http://dx.doi.org/10.1208/s12248-010-9226-9

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