Search results - 38 results
Establishment of a biological reference preparation for Hepatitis A Vaccine (Inactivated, Non-adsorbed)4425
C/D) was adopted at the June 2009session of the European Pharmacopoeia (Ph. Eur.) Commission as the Ph. Eur. BRP batch 1 for hepatitis A vaccine(inactivated, non-adsorbed), with an assigned potency of 12 ...
Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines.1
Comparison comparisons Control Correlation council of europe Cricetinae Cricetulus data Europe European European Commission Follow up FOLLOW-UP health healthcare Help Histamine Human im immunology Increase ...
International collaborative study to establish reference preparations to standardise haemagglutination testing for Anti-A and Anti-B in normal intravenous Immunoglobulins by the direct method
used.The Positive control, Negative control and Limit test preparations were adopted in November 2008 by the Commissionof the European Pharmacopoeia (Ph. Eur.) as Biological Reference Preparations. The same ...
Establishment of the Ph. Eur. BRP for Varicella Vaccine Batch 1227
Keywords: 2009 a an AS at Common Control Countries data Establish EU European International IS method methods ON PARTICIPANTS ph stability study use vaccine Validate VIRUS Abstract: The European Pharmacopoeia ...
Collaborative Study for the Validation of Alternative in vitro Potency Assays for Human Tetanus Immunoglobulin
study System Term Test TESTING Tetanus time Validate VALIDATION values work Abstract: The European Pharmacopoeia (Ph. Eur.) monograph Human tetanus immunoglobulin (0398) gives a clear outline of the in ...
Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.
Antibodies, Viral Chickenpox Vaccine Europe Freeze Drying Herpesvirus 3, Human Humans Pharmacopoeias as Topic Reference Standards Reproducibility of Results Abstract: The European Pharmacopoeia (Ph. Eur.) ...
Establishment of Replacement Batches for Prekallikrein Activator in Albumin Biological Reference Preparation
BRP batch 1. Sixteen laboratories participated in the collaborative study and were requested to assay the candidates by their routine method, complying with the European Pharmacopoeia (Ph. Eur.) general ...
Indirect foot-and-mouth disease vaccine potency testing based on a serological alternative.
serum titres of primo-vaccinated cattle and protection against infection have been proposed, but none have been accepted by the European Pharmacopoeia (Ph.Eur.) due to the lack of statistical power and ...
FMD vaccines: reflections on quality aspects for applicability in European disease control policy.
for prophylactic or emergency use, generally manufactured by the same basic methodology outlined in the OIE Manual and, for Europe, in the European Pharmacopoeia, and for the EU Member States in ...
Foot-and-mouth disease vaccine potency testing in cattle using homologous and heterologous challenge strains: precision of the "Protection against Podal Generalisation" test.
with VACC and VCON values of 65.7% and 59.2%, respectively. Results indicate that the homologous PPG test is more reliable than the European Pharmacopoeia potency test, but that a larger number of ...