Cargando…
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) have been leaders in protecting and promoting the U.S. public health by helping to ensure that safe and effective drugs and biological product...
Autores principales: | Ionan, Alexei C., Clark, Jennifer, Travis, James, Amatya, Anup, Scott, John, Smith, James P., Chattopadhyay, Somesh, Salerno, Mary Jo, Rothmann, Mark |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9718464/ https://www.ncbi.nlm.nih.gov/pubmed/36459346 http://dx.doi.org/10.1007/s43441-022-00483-0 |
Ejemplares similares
-
Lessons from CDER’s Quality Management Maturity Pilot Programs
por: Maguire, Jennifer, et al.
Publicado: (2023) -
Pre-Launch Absolute Calibration of CCD/CBERS-2B Sensor
por: Ponzoni, Flávio Jorge, et al.
Publicado: (2008) -
Workgroup Report: Review of Genomics Data Based on Experience with Mock Submissions—View of the CDER Pharmacology Toxicology Nonclinical Pharmacogenomics Subcommittee
por: Leighton, John K., et al.
Publicado: (2006) -
Complete Coding Region Sequence of a Chikungunya Virus Strain Used for Formulation of CBER/FDA RNA Reference Reagents for Nucleic Acid Testing
por: Añez, Germán, et al.
Publicado: (2014) -
Identification of Parasite-Host Habitats in Anxiang County, Hunan Province, China Based on Multi-Temporal China-Brazil Earth Resources Satellite (CBERS) Images
por: Zhang, Zhijie, et al.
Publicado: (2013)