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| Andrade,E.L.; Bento,A.F.; Cavalli,J.; Oliveira,S.K.; Schwanke,R.C.; Siqueira,J.M.; Freitas,C.S.; Marcon,R.; Calixto,J.B.. |
| The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Non-clinical studies; GLP studies; Safety; Pharmacokinetics; Toxicology. |
| Ano: 2016 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2016001200301 |
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| 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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