An Atamestane registration batch is one or more lots of the drug ingredient or product manufactured under GMP conditions in order to support the submission of a marketing application for Licensed Product or a new drug application.
Final stability and bioavailability tests will be conducted on these batches of product made in accordance with GMP. These lots should be produced at a size that is at least 1:10 of the commercial scale that is being proposed. Registrant batches should be produced utilizing techniques and equipment that are typical of the full-scale production. The FDA mandates the production of at least one registration lot on-site, using the real equipment. The number of required registration lots is determined based on 1) manufacturing site(s) of the bulk drug substance, 2) number of dosage strengths, and 3) manufacturing site(s) for final drug product.
