Cargando…
Research and Education Needs for Complex Generics
Complex generics are generic versions of drug products that generally have complex active ingredients, complex formulations, complex routes of delivery, complex dosage forms, are complex drug-device combination products, or have other characteristics that can make it complex to demonstrate bioequiva...
Autores principales: | Stern, Sydney, Coghlan, Jill, Krishnan, Vishalakshi, Raney, Sam G., Babiskin, Andrew, Jiang, Wenlei, Lionberger, Robert, Xu, Xiaoming, Schwendeman, Anna, Polli, James E. |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8732887/ https://www.ncbi.nlm.nih.gov/pubmed/34950975 http://dx.doi.org/10.1007/s11095-021-03149-y |
Ejemplares similares
-
Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview
por: Babiskin, Andrew, et al.
Publicado: (2023) -
Increasing impact of quantitative methods and modeling in establishment of bioequivalence and characterization of drug delivery
por: Yoon, Miyoung, et al.
Publicado: (2023) -
Interchangeability of Generics—Experiences and Outlook Toward Pharmacokinetics Variability and Generic‐Generic Substitution
por: Yu, Yang, et al.
Publicado: (2018) -
Advances in quantitative methods and modeling for complex generic drugs and opportunities to hybridize learnings between innovator and generic drug developers
por: Jayachandran, Priya
Publicado: (2023) -
Integrating tropical research into biology education is urgently needed
por: Russell, Ann E., et al.
Publicado: (2022)