Как цитировать
Аннотация
Was studied in vitro bioequivalence of Ofloxacin tablets (200 mg, Borisovo Ltd,Belarus) with the reference preparation Ofloxin (200 mg, Zentiva Ltd, Czech Republic), using a dissolution test and comparing the dissolution profiles. The data of the research show that both the reference and the study drug correspond to the requirements of USP and consequently, they are pharmaceutically equivalent. The results received during validation of the dissolution test at pH 4.5 and pH 6.8, have shown full conformity of the developed method to requirements Guidance for Industry Bioanalytical Method Validation U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM) May 2001 on the following validation characteristics: Specificity, Precision, Linearity and Accuracy. A comparison of the dissolution profiles of the tablets of Ofloxin and Ofloxacin shows that there is no statistically significant difference in dissolution kinetics between them and, consequently, they are equivalent in vitro.
Библиографические ссылки
WHO Technical Report Series, No. 937, 2006, app. N7
http://www.fda.gov/cder/ogd/index.htm
Joint Statement. between The International Pharmaceutical Federation (FIP) and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA): Ensuring Quality and Safety of Medicinal Products to Protect the Patient. - Geneva: FIP, IFPMA, 2002.
HHS/FDA Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products – general considerations. Rockville, MD, 388
Department of Health and Human Services, US Food and Drug Administration. 2003 (http://www.fda.gov/cder/ guidance/index.htm).
USP 40 NF 35
“Floxin Tablets (ofloxacin tablets)”. Centerwatch. Floxin Tablets New FDA Drug Approval | CenterWatch. Retrieved August 25, 2016;
“Floxin otic New FDA Drug Approval”. Centerwatch;