Search results - 25 results

Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium

characterization of SF-antimicrobials, collected samples were also evaluated in terms of impurities and dissolution. The impurities were analyzed based on the methods of the European Pharmacopoeia (Ph. Eur.) and the ...

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 ...

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 ...

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