Requirements for the information on reference standards submitted in the dossier for biologicals
R. A. Volkova,
O. V. Fadeikina,
O. B. Ustinnikova
et al.
Abstract:SCIENTIFIC RELEVANCE. The use of appropriately certified reference standards (RSs) is a necessary element of analytical procedure standardisation that ensures comparability of results across different laboratories assessing the quality of medicines, which is important for the quality control of biologicals. Marketing authorisation involves providing information on RSs, but no specific requirements are given for the relevant section of the dossier. Therefore, it is necessary to develop the requirements for the … Show more
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