Technical considerations on non-clinical study and evaluation for biosimilar products / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 480-482, 2015.
Artigo
em Chinês
| WPRIM
| ID: wpr-859414
ABSTRACT
OBJECTIVE:
To evaluate biosimilar products focus on the similarities in the quality, safety and eificacy between the candidate and reference products.METHODS:
Comparative non-clinical studies should be conducted and stepwise development should be carried out to demonstrate the similarity in non-clinical study for the candidate and reference products. Usually the necessity and content of in vivo study are dependent on the results of previous comparative studies in vitro. RESULTS ANDCONCLUSION:
Determination of the non-clinical similarity should be based on the statistical analysis of the candidate and reference products. Evaluation for toxicity similarities can focus on toxicity profile in types and extent. The non-clinical similarities will affect the strategy of clinical trial for biosimilars.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Idioma:
Chinês
Revista:
Chinese Pharmaceutical Journal
Ano de publicação:
2015
Tipo de documento:
Artigo
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