Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies

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 investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

Atividade antinociceptiva do extrato etanólico do fruto de Solanum acanthodes Hook.f. em camundongos

Solallum acanthodes. popularmente conhecido como "jurubeba", foi estudada com o objetivo de avaliar suas propriedades antinocicept i vas nos modelos de nociccpção induzida pela I'ormalina e glutamato. Para isto foi utilizado o extrato elanólico dos frutos (EES) da planta. Os resultados apresentaram altos níveis de significância, demonstrando o potencial analgésico de S. acanthodes.

Solanum acanthodes, popularly known as "jurubcba", was studied with the objective to evaluatc its antinocíccptivc propcrties In lhe models aI' fonnalin-induced nociceptive and glutamate. For this lhe cthanolic extract of lhe fruits (E.ES) of the plant was used. The results had prescnlcd high lcvcls 01' significance, demonstrating lhe analgesic potcntial of S. acanthodes.