New challenges and opportunities in nonclinical safety testing of biologics.
Regul Toxicol Pharmacol
; 69(2): 226-33, 2014 Jul.
Article
em En
| MEDLINE
| ID: mdl-24755365
ABSTRACT
New challenges and opportunities in nonclinical safety testing of biologics were discussed at the 3rd European BioSafe Annual General Membership meeting in November 2013 in Berlin (i)Approaches to refine use of non-human primates in non-clinical safety testing of biologics and current experience on the use of minipigs as alternative non-rodent species.(ii)Tissue distribution studies as a useful tool to support pharmacokinetic/pharmacodynamic (PKPD) assessment of biologics, in that they provide valuable mechanistic insights at drug levels at the site of action.(iii)Mechanisms of nonspecific toxicity of antibody drug conjugates (ADC) and ways to increase the safety margins.(iv)Although biologics toxicity typically manifests as exaggerated pharmacology there are some reported case studies on unexpected toxicity.(v)Specifics of non-clinical development approaches of noncanonical monoclonal antibodies (mAbs), like bispecifics and nanobodies.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Segurança
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Produtos Biológicos
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Testes de Toxicidade
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Avaliação Pré-Clínica de Medicamentos
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Anticorpos Monoclonais
Limite:
Animals
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Humans
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Ano de publicação:
2014
Tipo de documento:
Article