Non-mutagenic impurities - Recent industry experience of using dose durational limits in drug development.
Regul Toxicol Pharmacol
; 147: 105559, 2024 Feb.
Article
em En
| MEDLINE
| ID: mdl-38145838
ABSTRACT
Absence of clear guidance on the qualification threshold for non-mutagenic impurities during clinical development is a source of inconsistency in both sponsor qualification approaches and health authority requests. A survey was conducted in March 2020 with 6 member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Thirteen examples were gathered of where non-International Council for Harmonisation (ICH) limits have been used in regulatory submissions for various indications and stages of development, together with the regulatory outcomes. As expected, few challenges were faced in early clinical development, with health authorities generally commenting that sponsors should work towards ICH Q3A and Q3B guideline specification limits as development progresses. However, inconsistent health authority requests were noted even for early phase clinical trials in late-stage oncology patients. For an optimised use of resources, consistent approaches would have the benefit of supporting faster access of safe medicines to patients while including Replacement, Reduction and Refinement (the 3Rs) considerations with respect to animal testing.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Desenvolvimento de Medicamentos
/
Neoplasias
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Regul Toxicol Pharmacol
Ano de publicação:
2024
Tipo de documento:
Article
País de publicação:
Holanda