Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Mol Pharm
; 21(5): 2065-2080, 2024 May 06.
Article
em En
| MEDLINE
| ID: mdl-38600804
Palavras-chave
MIDD (model informed drug development); PBBM (physiologically based biopharmaceutics model(s)(ing); PBPK (physiologically based pharmacokinetics); biopredictive dissolution; clinically relevant dissolution specifications (CRDS); drug product performance; drug product quality; patient-centric drug product quality standards; safe space; virtual bioequivalence (VBE)
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Biofarmácia
/
Indústria Farmacêutica
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Mol Pharm
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Bélgica