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| Cunha,J.F.; Campestrini,F.D.; Calixto,J.B.; Scremin,A.; Paulino,N.. |
| We examined some of the mechanisms by which the aspirin metabolite and the naturally occurring metabolite gentisic acid induced relaxation of the guinea pig trachea in vitro. In preparations with or without epithelium and contracted by histamine, gentisic acid caused concentration-dependent and reproducible relaxation, with mean EC50 values of 18 µM and Emax of 100% (N = 10) or 20 µM and Emax of 92% (N = 10), respectively. The relaxation caused by gentisic acid was of slow onset in comparison to that caused by norepinephrine, theophylline or vasoactive intestinal peptide (VIP). The relative rank order of potency was: salbutamol 7.9 > VIP 7.0 > gentisic acid 4.7 > theophylline 3.7. Gentisic acid-induced relaxation was markedly reduced (24 ± 7.0, 43... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Gentisic acid; Potassium channels; Vasoactive intestinal peptide; VIP; Trachea; Smooth muscle. |
| Ano: 2001 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2001000300013 |
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| Calixto,J.B.. |
| This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Herbal medicine; Efficacy; Safety; Quality control; Market; Regulatory guidelines. |
| Ano: 2000 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2000000200004 |
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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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