Drug development

Drug development is refers to the once appeared in the process of drug discovery of new molecular entity (NME), will be new pharmaceutical drug production process.This new NME has good activity to a particular target.

Before the clinical development process, before any human clinical trials, must determine the NME, toxicity and safety of the characteristics of the pharmacokinetic and metabolism, and puts forward Suggestions for the dose and schedule.In addition, it is necessary to determine the physical and chemical properties of NME.Important parameter is the chemical composition, molecular and crystal structure as well as relevant important features, such as stability and bioavailability.Impurity analysis and understanding of polycrystalline model is very important to conducting clinical trials.Further development process including the scale and is suitable for packaging, at the same time, a thorough analysis and monitoring of these processes may be any influence on the NME awards: for example, the change of the impurity composition, appearance or disappearance of polycrystalline type and so on.Once the efficacy and safety of drug candidates with acceptable can start clinical test, at the same time the characteristics of continuous analysis.

Brooke provide a wide range of technology, methods and applications, is used to NME characterization, to support one of the most important drug development process.Single molecule and crystal structure characterization, and related to the structure characteristics, impurity analysis, determination of potency and so on.Brooke unique mass spectrometry, nuclear magnetic resonance (NMR) system, FT - IR/FT - NIR, RAMAN, XRD and XRF instrument suite provides valuable solutions, to provide highly complementary data, enhance the understanding of the whole of candidate drugs, and to assist decision-making, in order to realize the production and the final regulatory approval.