Search results - 18 results
Clustering of Tadalafil API Samples According to their Manufacturer in the Context of API Falsification Detection
Official Medicines Control Laboratory Network (GEON), on tadalafil. A classical market surveillance study, evaluating compliance to the European Pharmacopoeia, was combined with a fingerprint study, the ...
GEONs API fingerprint project: Selection of analytical techniques for clustering of sildenafil citrate API samples
the Quality of Medicines & HealthCare (EDQM), regularly organises market surveillance studies for specific API s for conformity to their monograph in the European Pharmacopoeia. During the past ...
European fingerprint study on omeprazole drug substances using a multi analytical approach and chemometrics as a tool for the discrimination of manufacturing sources
substances and prevent the use of non-compliant API s, Official Medicine Control Laboratories work together in a European network developing coordinated strategies and programmes. The API working group ...
A simple dilute-and-shoot method for screening and simultaneous quantification of nicotine and alkaloid impurities in electronic cigarette refills (e-liquids) by UHPLC-DAD
quality control of nicotine related impurities, for which the European Pharmacopoeia limits are currently applied, the sensitivity of the UHPLC- DAD method was found to be within the acceptable range. ...
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 ...
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 ...
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 ...
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.) ...
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 ...