A Quantitative Clinical Pharmacology-Based Framework For Model-Informed Vaccine Development.
J Pharm Sci
; 113(1): 22-32, 2024 01.
Article
em En
| MEDLINE
| ID: mdl-37924975
ABSTRACT
Historically, vaccine development and dose optimization have followed mostly empirical approaches without clinical pharmacology and model-informed approaches playing a major role, in contrast to conventional drug development. This is attributed to the complex cascade of immunobiological mechanisms associated with vaccines and a lack of quantitative frameworks for extracting dose-exposure-efficacy-toxicity relationships. However, the Covid-19 pandemic highlighted the lack of sufficient immunogenicity due to suboptimal vaccine dosing regimens and the need for well-designed, model-informed clinical trials which enhance the probability of selection of optimal vaccine dosing regimens. In this perspective, we attempt to develop a quantitative clinical pharmacology-based approach that integrates vaccine dose-efficacy-toxicity across various stages of vaccine development into a unified framework that we term as model-informed vaccine dose-optimization and development (MIVD). We highlight scenarios where the adoption of MIVD approaches may have a strategic advantage compared to conventional practices for vaccines.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Farmacologia Clínica
/
Vacinas
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article