Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER.
Ther Innov Regul Sci
; 57(3): 436-444, 2023 05.
Article
en En
| MEDLINE
| ID: mdl-36459346
ABSTRACT
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 products are available in the United States for those who need them. The null hypothesis significance testing approach, along with other considerations, is typically used to demonstrate the effectiveness of a drug or biological product. The Bayesian framework presents an alternative approach to demonstrate the effectiveness of a treatment. This article discusses the Bayesian framework for drug and biological product development, highlights key settings in which Bayesian approaches may be appropriate, and provides recent examples of the use of Bayesian approaches within CDER and CBER.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Productos Biológicos
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2023
Tipo del documento:
Article
País de afiliación:
Estados Unidos