Past IJET - IJET-28 in Columbus
Sessions
Translating Chemistry, Manufacturing, and Controls
Information To assure the proper identification, quality, purity, and strength of an investigational new drug (IND), the US FDA requires IND applications to include “a section describing the composition, manufacture, and control of the drug substance and the drug product.” The amount of this so-called chemistry, manufacturing, and controls information in the application will vary according to factors such as the phase, size, and duration of the investigation, the dosage form, and the patient population. In this presentation, I will review examples of information typically included in the CMC section of an IND application, and suggest strategies for their translation from Japanese into English. The presentation will be ideally suited to J-E translators working in the biomedical and pharma field.
