Development and Approval of Combination Products / Siegel, Evan B.  

Público ISBD Ningún comentario para este título. Título : Development and Approval of Combination Products  : A Regulatory Perspective Tipo de documento: documento electrónico Autores: Siegel, Evan B. Editorial: Wiley Fecha de publicación: 2008 Número de páginas: xii, 215 p. : Il.: ill. Palabras clave:   United States.  Drug approval  United States.  Biological products  United States.  Medical instruments and apparatus  United States. Clasificación: 363.19/46 Nota de contenido: bla Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier. Enlace de acceso : https://elibro-net.biblioproxy.umanizales.edu.co/es/lc/umanizales/titulos/177758 Development and Approval of Combination Products  : A Regulatory Perspective [documento electrónico] / Siegel, Evan B. . - Wiley, 2008 . - xii, 215 p. : : ill. Palabras clave:   United States.  Drug approval  United States.  Biological products  United States.  Medical instruments and apparatus  United States. Clasificación: 363.19/46 Nota de contenido: bla Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier. Enlace de acceso : https://elibro-net.biblioproxy.umanizales.edu.co/es/lc/umanizales/titulos/177758

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