An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow.
AAPS J
; 24(3): 49, 2022 03 29.
Article
em En
| MEDLINE
| ID: mdl-35348922
ABSTRACT
Assessment of bioperformance to inform formulation selection and development decisions is an important aspect of drug development. There is high demand in the pharmaceutical industry to develop an efficient and streamlined approach for better understanding and predicting drug product performance to support acceleration of clinical timelines. This manuscript presents an effort from the IQ Formulation Bioperformance Prediction Working Group composed of members from 12 pharmaceutical companies under the IQ Consortium to develop a database around the topic of formulation bioperformance prediction and report findings from the database analysis. Six case studies described in the manuscript demonstrate how bioperformance models were used to predict in vivo performance and to provide guidance addressing questions encountered during oral solid dosage form development. The case studies also described findings of a correlation between in vitro dissolution and in vivo performance and how dissolution data can be incorporated into physiologically based biopharmaceutical modeling. Finally, a workflow for how in vitro dissolution data can be utilized to predict clinical bioperformance of oral solid dosage forms is proposed.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Desenvolvimento de Medicamentos
/
Modelos Biológicos
Tipo de estudo:
Guideline
/
Prognostic_studies
Idioma:
En
Revista:
AAPS J
Assunto da revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Estados Unidos