Demystifying the complex terminology of drug development, regulatory standards, and biopharma operations.
A Contract Development and Manufacturing Organization (CDMO) specializes in drug development and manufacturing. CDMOs provide services that range from drug discovery and pre-clinical stages to full-scale commercial manufacturing.
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
An Abbreviated New Drug Application (ANDA) is an application for a generic drug approval for an existing licensed medication or approved drug.
An Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.
Modality refers to the way in which a drug or medical treatment acts. Common modalities include small molecules, monoclonal antibodies (mAbs), cell and gene therapies, and mRNA.
The Common Technical Document (CTD) is a set of specifications for a registration application that will be accepted by regulatory authorities in relevant countries.
A Contract Research Organization (CRO) provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
Clinical trial phases are the stages in which scientists conduct experiments with a health intervention in an attempt to learn about its effects, safety, and effectiveness.
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