During drug development, emphasis is placed on process optimization and efficient quality control to prevent expensive mistakes on a large scale. These processes often include the entire cycle of drug discovery, from concept to drug product development to testing and regulatory approval.
Drug discovery is the process by which new chemical entities are identified, established and validated to maximise their potential toxicity and safety. There are five common stages in the process of drug discovery that include:
1. Extraction/ Synthesis
The most common ways to collect a sample are through reflux synthesis and Soxhlet extraction. The two methods of drug discovery process may be performed with the rotary evaporator. These methods are highly automated, which helps you achieve higher yields in less time.
You can use the same equipment you used in your research to scale up production. However, when scaling up for drug discovery applications, try to keep the same parameters from your Reflux synthesis or Soxhlet extraction steps. To help you achieve this, consider using equipment that is compatible with both smaller flask sizes and industrithe al-sized labware. An industrial evaporator can be used to scale up synthesis or extraction of target compounds.
2. Concentration –
Here are some time-saving tips for you to help make the most of your evaporator. First, consider using parallel evaporation to dry multiple samples simultaneously or a Dewar accessory to help prepare your sample for freeze drying directly on your rotary evaporator.
When you reach the purification stage and have a nice pure compound, I would suggest using flash chromatography as a quick pre-purification step. Then I would follow-up with prep HPLC to reach higher purity of the target compound, and use systems with both UV detectors and ELS detectors to ensure you don’t miss your target of interest.
The stages of drug discovery require different systems with different capacities. When creating a broad range of options, it becomes possible to modify the operating environment according to the project. Try out different prep methods and HPLC columns, depending on what you’re looking for in terms of performance, resolution or storage capacity. Make sure your vessels have appropriate syringes and pumps.
4 – Concentration by freeze drying –
Separation is the first and most important step of drug discovery. Separation is the process of removing unwanted components to concentrate your compound of interest. This process can be performed using a variety of solvents, but freeze drying is one of the safest, most efficient and cost-effective alternatives.
- Determination of purity –
The last step in drug discovery, similarly to the analysis of the final chocolate products, involves stringent quality control. One way to analyse the purity of your compound is to determine the melting point of your target compound.
In recent years, the advent of advanced methodology for drug development has led to a transformation in the drug discovery process. A key challenge has been the need to synthesise chemicals or biological molecules with novel properties that are relatively small and easy to produce. Furthermore, it is not always easy to incorporate these compounds into formulated products without losing properties or displaying unwanted characteristics.
The steps that you learn in this course can be applied to both drug discovery as well as chemical novel compound discovery. If you combine the knowledge from these two courses it will allow you to run a full drug discovery workflow on your own.
Clinical trials CRO is not a single step but many stages of drug development. Clinical Trials are a way for companies to test the safety and effectiveness of a new drug by monitoring the experience of people whose health has been affected by taking it. The goal of clinical trials is to provide scientific data that will help evaluate the usefulness of a new medicine, which generally involves testing patients with specific diseases or conditions to see if their condition changes or improves after they take it.