Interchangeability Criteria for Levofloxacin-Based Medicinal Products in the Russian Federation


Дәйексөз келтіру

Толық мәтін

Ашық рұқсат Ашық рұқсат
Рұқсат жабық Рұқсат берілді
Рұқсат жабық Тек жазылушылар үшін

Аннотация

The present research was aimed at finding informative criteria for regulating the procedure to determine the interchangeability of systemic levofloxacin-based medicinal products (MP) registered in the RF. The chemical and pharmaceutical characteristics of excipients in 26 commercial levofloxacin products (film-coated tablets for internal use) were compared. Their product lines and instructions for medicinal use were also analyzed. It was shown that the compositions of levofloxacin tablets offered on the RF market differed significantly. It was established that the elaboration and implementation of informative criteria for regulating the procedure to determine the interchangeability of levofloxacin-based drugs should benefit the evaluation of drug quality during the determination of the interchangeability for medicinal use.

Авторлар туралы

V. Kocherovets

Ministry of Public Health of the Russian Federation, I. M. Sechenov First Moscow State Medical University; Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Ресей, Moscow, 119991; Moscow, 127051

N. Bunyatyan

Ministry of Public Health of the Russian Federation, I. M. Sechenov First Moscow State Medical University; Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Ресей, Moscow, 119991; Moscow, 127051

Yu. Olefir

Ministry of Public Health of the Russian Federation, I. M. Sechenov First Moscow State Medical University; Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Ресей, Moscow, 119991; Moscow, 127051

R. Alyautdin

Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Ресей, Moscow, 127051

B. Romanov

Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Ресей, Moscow, 127051

A. Prokof’ev

Ministry of Public Health of the Russian Federation, I. M. Sechenov First Moscow State Medical University; Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Public Health of the Russian Federation

Email: chem@folium.ru
Ресей, Moscow, 119991; Moscow, 127051

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