CDMO: Contract Development and Manufacturing Organizations
CMO: Contract Manufacturing Organizations
CRDMO: a combination CDMO and CRO
Drug Substances: also known as APIs are the main pharmaceutically active component of a medicinal product.
Excipients: are pharmacologically inactive substances that are generally used as a carrier of the API in the drug.
Drug Product: the finished product of any drug that is available in the market and is ready to use.
Pharmaceutical development: activities that result in advancing a potentially new drug candidate into clinical practice.
Pre-formulation studies: laboratory studies conducted to determine the characteristics of drug components.
Formulation Development: the process through which a variety of substances are combined with the drug’s API.
Analytical method development: the process of selecting an accurate assay procedure to determine the composition of a formulation.
Pharmaceutical manufacturing: the process of producing pharmaceutical drugs for clinical use.
GMP: Good Manufacturing Practice