Diagnostic Efficiency of Adsorbed Anthrax Vegetative Fluorescent Immunoglobulins Demonstrated in the Medical Trials

Studied is the diagnostic efficiency (specific activity, sensitivity, specificity, reproducibility) of anthrax vegetative fluorescent immunoglobulins. Based on the data, received in medical trials, this preparation is recommended for registration as a product for medical application in the Russian Federation

Recommendations on the procedure for determining the interchangeability of medicinal products

The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»)

Рекомендации по порядку определения взаимозаменяемости лекарственных препаратов

The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»).Представлены разработанные авторами рекомендации по порядку определения взаимозаменяемости лекарственных препаратов для медицинского применения. Взаимозаменяемость лекарственного препарата может быть установлена при государственной регистрации лекарственного препарата или при внесении изменений в документы, содержащиеся в регистрационном досье на лекарственный препарат. Рекомендуемая авторами очередность процедур определения взаимозаменяемости лекарственных препаратов включает в себя четыре последовательных этапа. Проведение оценки соответствия воспроизведенного лекарственного препарата референтному препарату предложено проводить по шести параметрам, указанным в Федеральном законе № 429-ФЗ, в определенной последовательности («алгоритм оценки взаимозаменяемости»)