Term of the Day
Natural History Study
A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.
Chemistry, Manufacturing, and Controls (CMC)
CMC stands for Chemistry, Manufacturing, and Controls, which refers to a set of activities related to the development, manufacture, and quality control of drugs, biologics, and other pharmaceutical products.In the context of clinical trials, CMC refers to the documentation and testing required to ensure the safety, purity, and potency of investigational products used in clinical trials. The CMC section of a regulatory submission typically includes information on the drug substance, drug product, and manufacturing process, as well as details on the analytical methods used to test the product for quality and stability.Some of the key activities included in CMC in clinical trials may include:
- Developing a manufacturing process for the drug substance and drug product.
- Conducting quality control testing to ensure the purity, potency, and safety of the drug substance and drug product.
- Developing and validating analytical methods to test the drug substance and drug product.
- Conducting stability testing to determine the shelf life and storage conditions of the drug product.
- Ensuring that the manufacturing process and quality control testing meet regulatory requirements and guidelines.
Overall, CMC is a critical component of the drug development process, as it ensures that investigational products used in clinical trials are safe and effective for patients, and meet regulatory requirements for approval.