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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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