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Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies BJMBR
Andrade,E.L.; Bento,A.F.; Cavalli,J.; Oliveira,S.K.; Freitas,C.S.; Marcon,R.; Schwanke,R.C.; Siqueira,J.M.; Calixto,J.B..
This review presents a historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Non-clinical drug discovery and development; Target discovery and validation; Proof of principles; Animal research robustness.
Ano: 2016 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2016001100301
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