A5027575964- Virus-based gene therapy research
- Viral gastroenteritis research and epidemiology
- Influenza Virus Research Studies
- Viral Infections and Outbreaks Research
- Viral Infectious Diseases and Gene Expression in Insects
- Hepatitis Viruses Studies and Epidemiology
- CRISPR and Genetic Engineering
There are a lot of diseases known today, which caused by genetic abnormalities. Advances in genetics and biotechnology brought about gene editing technologies that can produce almost any gene, ultimately led to the emergence new class medicines - therapy products (GTPs). The aim study was analyse international experience development authorisation GTPs. review highlights challenges GTP development, related search for an optimal approach therapeutic delivery target cells. Viral vectors were...
The experience with the influenza pandemic caused by strain A (H1N1) 2009 and existing gaps in standardizing evaluating quality effectiveness of vaccines for prevention have led European Union (EU) to recognize need review / update current guidelines on requirements development, quality, preclinical clinical research. In February 2018 Guideline -quality module (EMA/CHMP/BWP/310834/2012 Rev.l) came Into effect EU countries. formation Eurasian Economic (EAEU) creation a single market...
At present, there are not much data on the clinical use of live recombinant viral vector vaccines. Characteristics new vaccines should be factored into requirements/recommendations for quality control, preclinical and studies in order to enable further risk/benefit assessment. The aim this study was analyse current approaches paper provides an overview licensed those at various stages trials. authors analysed Russian, European, American, Japanese guidelines related issues, analysis...