Limit of Detection of Microorganisms in Drug Sterility Testing
Autor: | M. V. Roshchina, N. G. Sakhno, O. V. Gunar |
---|---|
Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
Pharmacology Alternative methods Detection limit Drug Chemistry business.industry Microorganism Sterility testing media_common.quotation_subject Sample (material) 030106 microbiology Pharmacology toxicology 01 natural sciences 0104 chemical sciences Biotechnology 010404 medicinal & biomolecular chemistry 03 medical and health sciences Drug Discovery business media_common |
Zdroj: | Pharmaceutical Chemistry Journal. 51:508-510 |
ISSN: | 1573-9031 0091-150X |
Popis: | The use of compendial and alternative methods for drug sterility testing, the most important characteristic of which is the limit of detection (LOD), i.e., the minimum amount of viable microorganisms that can be found in the examined sample, is currently regulated abroad. The goal of the research was to determine experimentally and compare the LODs of microorganisms by direct inoculation and using a BacT/ALERT 3D Microbial Detection System automated bacteriological analyzer. Statistically significant differences between the results obtained by the different methods were not found. |
Databáze: | OpenAIRE |
Externí odkaz: |