Pharmaceutical development is the process of bringing a new drug to market. It is a lengthy and expensive process that can take up to 10 years, and requires a substantial investment by the industry and the public. The goal of pharmaceutical development is to design a high-quality drug that is safe, effective, and reliable. This is achieved by assessing the safety of a drug candidate, designing the manufacturing process, and testing the absorption profile of the drug.
The pharmaceutical development process Research chemicals begins with the identification of a lead compound. Next, the compound is optimized for its activity against a biological target, and tested in laboratory models. These compounds are then developed into a formulation. To ensure that the formulation is viable and meets the needs of the clinical profile, it is manufactured in a form that meets the quality control tests.
In the United States, the Food and Drug Administration (FDA) requires that preclinical testing of a drug be performed before it is able to move onto human clinical trials. This ensures that the drug does not become dangerous if used on humans, and allows for the validation of the target. During this process, academic and industry scientists work together to identify new chemical entities. Also known as new molecular entities, these compounds have promising activity against a biological target.
Once a lead compound is selected, it is evaluated for its bioavailability, toxicity, and biodistribution. In addition, it is tested for its stability and route of administration. As a result of this extensive study, it is likely that formulations will be designed to meet the requirements of the regulatory agency.
At the time of product approval, the drug should be safe, effective, and reliable. Regulatory authorities review the quality of the product, including the safety of patients and the manufacturing process. Quality by design (QbD) is a process that identifies key attributes that define a good product, and reduces the number of post-approval changes.
QbD is a systematic approach to product development that uses multivariate experiments, process analytical technology, and risk assessment. Quality by design can shorten the development time, improve efficiency, and ensure that a drug’s performance is consistent with its attributes.
During the early stages of drug development, a company will focus on identifying a target and developing a small-scale version of the drug for clinical trials. Once the target has been identified, a pharmaceutical company will fund its development. Before a target can be funded, it is necessary to determine its feasibility and its commercial viability. Developing a target should also take into account the cost of developing the product, as well as whether it is appropriate for a certain disease.
Drug development often takes longer than expected. The duration of a project can vary from five to fifteen years, depending on the size of the company and the drug being developed. Although many of the larger companies have already fallen out of the drug market, smaller ones are springing up to fill the void.