Late-Stage Failures of Monoclonal Antibody Drugs: A Retrospective Case Study Analysis
| Autor: | Sun, Amy, Benet, Leslie Z |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Sirukumab
Bococizumab Pharmacology and Pharmaceutical Sciences Bavituximab Lampalizumab Antibodies Phase III as Topic Orphan Drug Rare Diseases Drug Development Monoclonal Late-stage failure Animals Humans Solanezumab Clinical Trials Treatment Failure Pharmacology & Pharmacy Tabalumab Retrospective Studies Biotechnology |
| Zdroj: | Pharmacology, vol 105, iss 3-4 |
| Popis: | AimTo 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.MethodsWe 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.ResultsIn 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.ConclusionBy 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. |
| Databáze: | OpenAIRE |
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