Search results - 38 results
Pre-registration efficacy study of a novel marker vaccine against classical swine fever on Maternally Derived Antibody negative (MDA-) target animals.
candidate CP7_E2alf produced under Good Laboratory Practice (GLP) conditions by Pfizer was tested on 40 six-week-old MDA-piglets according to the European Pharmacopoeia (Ph.Eur.) requirements. Single doses of ...
Collaborative study for the calibration of the Ph. Eur. prekallikrein activator in albumin BRP batches 4, 5 and 6
collaborative study was organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) to calibrate replacement batches for thecurrent European Pharmacopoeia (Ph. ...
Establishment of hepatitis A vaccine (inactivated, non-adsorbed) BRP batches 2 and 3
Medicine medicines method performance ph Quality result results STANDARD study use Users vaccine WHO Abstract: The current hepatitis A vaccine (HAV), inactivated, non-adsorbed, European Pharmacopoeia (Ph. ...
Calibration of Ph. Eur. BRP batch 4 for oral poliomyelitis vaccine (OPV)
for the quality control (QC) of polio vaccines. Stocks of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) batch 3 for the assay of OPV are dwindling and therefore ...
Collaborative study for the establishment of the human immunoglobulin for electrophoresis Ph. Eur. BRP batch 3
to the diminished stocks of the 2nd batch of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for human immunoglobulin for electrophoresis, in 2013, the European Directorate ...
Collaborative study for the establishment of the 2 Ph. Eur. Human Immunoglobulin for Electrophoresis BRP batch 3 3
programme Project Quality routine study TESTING use Users Abstract: The current European Pharmacopoeia (Ph. Eur.) Human immunoglobulin for electrophoresis Biological Reference Preparation (BRP) batch 2 was ...
Regulatory issues regarding manufacture and control of vaccine adjuvants. The EU situation.
at batch release Belgian Change Clinical clinical trial Clinical trials Combination Components Control developing Development distribution EU European future Group Guidelines health Hepatitis Hepatitis ...
Calibration of the human immunoglobulin BRPs for ACA and molecular size (batch 1) and for Fc function and molecular size (batches 1 & 2)
study,European Pharmacopoeia. Immunoglobulin International IS IT Laboratories Medicine medicines Molecular ON ph Project Quality Requirements result results Sample Samples Size SIZES STANDARD study Test tests ...
Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for Tetanus Vaccine (Adsorbed) Batch 3).
World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) to establishreplacement batches for the European Pharmacopoeia (Ph. Eur.) Tetanus Vaccine (adsorbed) ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
eighties of last century; the European Pharmacopoeia has invested time and effort in the reduction, the replacement and the refinement of animal tests, better known as the 3R's principle.During the past ...