Evaluation of the current legislation and guidance documents applied to bioassays in clinical trials: a case study to prove the vaccines immunogenicity
DOI:
https://doi.org/10.22239/2317-269X.00734Keywords:
Bioassays, Quality Control, Vaccines, Official Compendia, Current LegislationAbstract
Vaccines are immunobiologicals products considered safe, effective and essential to control and / or eradication of vaccine-preventable diseases, and they were submitted to analytical tests and bioassays to check the quality and therapeutic efficacy. In this study was evaluated the applicability of the Executive Director Resolution of the National Health Surveillance Agency, (Anvisa), RDC nº 27 May 17, 2012 and analyzed the other standardized bioassays documents recommended to the World Health Organization, Food and Drug Administration, United States Pharmacopeia, European Medicines Agency and data literature. The analyses of data literature and regulation statutes showed inconsistent guidelines. This study showed that is essential create a more targeted legislation to respond the particularities of bioanalytical assays in clinical trials to ascertain the vaccines immunogenicity. In order to corroborate with this guideline elaboration was carried out a case study by a standardized measles virus plaque reduction neutralization test in a 96-well plates (Micro-PRNT) to measure vaccinia neutralization according to RDC nº 27 May 17, 2012, 27 focus on the effectiveness of tests that is used in vaccine generated immune responses studies. The results showed that the method provides the selectivity and specificity required for applicability in combination vaccines as MMR (mumps, measles and rubella) or MMRV (measles, mumps, rubella and varicella vaccine).Downloads
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