Biowaiver as a Bioequivalence Study Option
SCIENTIFIC RELEVANCE. Biowaiver is a procedure for establishing the bioequivalence of generic and reference products without in vivo studies. Regulatory requirements for this procedure, as described in a variety of documents, differ in certain features and aspects. These differences need to be analy...
| Principais autores: | , , , |
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| Formato: | Artigo |
| Idioma: | Russian |
| Publicado em: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2024-02-01
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| coleção: | Регуляторные исследования и экспертиза лекарственных средств |
| Assuntos: | |
| Acesso em linha: | https://www.vedomostincesmp.ru/jour/article/view/569 |