Late-Stage Failures of Monoclonal Antibody Drugs: A Retrospective Case Study Analysis.
Pharmacology
; 105(3-4): 145-163, 2020.
Article
em En
| MEDLINE
| ID: mdl-31910414
ABSTRACT
AIM:
To analyze the late-stage failures of monoclonal antibody drugs. The later a drug fails in development, the more time and expense is incurred by the sponsor.METHODS:
We review the late stage, Phase III, failures of 21 monoclonal antibody drugs between 2014 and 2019 using published and publicly available information to characterize the reasons for these failures.RESULTS:
In some cases, the failures are unavoidable due to the lack of adequate science, but in others, we characterize the causes of such failures and recommend how such failures may have been avoided.CONCLUSION:
By learning from previous mistakes and adhering to the principles and recommendations provided, it is possible to avoid these common pitfalls, increasing the likelihood of success in phase III clinical trials, and thus securing regulatory approval.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Desenvolvimento de Medicamentos
/
Anticorpos Monoclonais
Tipo de estudo:
Guideline
/
Observational_studies
/
Risk_factors_studies
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Pharmacology
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos