The role of CymitQuimica in drug development
One of the most important sectors we are working with in CymitQuimica is the pharmaceutical sector. In our catalogue you can find products for the research, synthesis, and analysis of different pharmaceutical products. For this reason, today we would like to explain the stages of drug development and the importance of CymitQuimica in this process.
Drug Discovery:this is the first stage. The drug target is selected, and an initial compound is searched for and characterized. This process usually lasts 2-5 years and consists of several phases:
Screening of many molecules to identify the target compound. In this case, our compound libraries could be used.
Biological and chemical evaluation: activity, selectivity, physicochemical properties, etc. Verification that the lead molecule is viable. At this stage, our standards,g., physicochemical standards, would be indispensable.
Optimization: structural modifications to improve the specificity and selectivity, pharmacokinetics, and safety of our compound. At this stage it is necessary to use organic reagents, buffer solutions, etc. At the end of this stage, we will obtain the candidate drug or novel chemical entity.
Preclinical:in this second stage, pharmacokinetic and short-term toxicology studies are carried out, as well as formulation and synthesis. It usually lasts between 1-5 years. In CymitQuimica we have a wide variety of organic compounds and solutions of very high quality ready to perform organic synthesis. We also have all the reference standards to be able to carry out quality controls.
Clinical Trials or clinical studies:These last about 6-7 years and are divided into several stages:
Phase 1: pharmacokinetic, tolerability and side effect studies in healthy volunteers (20-100 volunteers).
Phase 2: Small-scale patient trials to define efficacy and dose, long-term toxicity studies (100-500 volunteers).
Phase 3: Large-scale clinical studies (1000-5000 volunteers).
Review:for the drug to be approved by the responsible institution in each country (FDA, AEMPS) it is necessary to ensure high safety, purity, and quality. To demonstrate that this is the case, a dossier presenting the results of the clinical studies and the purity and quality studies, etc. is required. To be able to perform some of these studies you can find all the pharmacopoeia standards on our website.
Once the drug has been tested, it can move to the production phase and be commercialized. Once commercialized, pharmacovigilance studies will follow to ensure that no new side effects appear.