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Résultats de la recherche - 12 results

Biological reference standards for multivalent vaccines: qualification strategies and challenges from a national control lab perspective

reference qualification reference vaccine Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical laboratories Efficacité et sécurité des vaccins, médicaments ...

Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.

reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, ...

Ensuring batch continuity of non-compendial reference & standard materials from biological origin

Medicines & HealthCare (EDQM),Council of Europe, NA (2016) Keywords: meeting ORIGIN STANDARD Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical ...

Detection and risk evaluation of counterfeit medicines based on physico-chemical properties: the fingerprint and chemometrics approach

fingerprinting has been shown to be useful to screen herbal preparations for the presence of forbidden or regulated plants. The disadvantage of this approach is that a reference standard of the targeted plants ...

A validated GC-MS method for the determination and quantification of residual solvents in counterfeit tablets and capsules.

(2012) Keywords: Calibration Capsules Counterfeit Drugs Drug Contamination Fraud Gas Chromatography-Mass Spectrometry Limit of Detection Reference Standards Reproducibility of Results Solvents Tablets ...

A validated Ultra High Pressure Liquid Chromatographic method for the characterisation of confiscated illegal slimming products containing anorexics.

Depressants Calibration Chromatography, High Pressure Liquid Dietary Supplements Drug Combinations Drug Contamination Limit of Detection Linear Models Reference Standards Reproducibility of Results Abstract: ...

Detection of counterfeit Viagra® by Raman microspectroscopy imaging and multivariate analysis.

Studies Fraud Lactose Microspectrophotometry Multivariate Analysis Phosphodiesterase 5 Inhibitors Piperazines Principal Component Analysis Purines Reference Standards Reproducibility of Results Sildenafil ...

A validated ultra high pressure liquid chromatographic method for qualification and quantification of folic acid in pharmaceutical preparations.

Keywords: Analysis of Variance Calibration Chromatography, High Pressure Liquid Folic Acid Limit of Detection Pharmaceutical Preparations Reference Standards Reproducibility of Results Vitamins Abstract: ...

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.) ...

Current practices in antinuclear antibody testing: results from the Belgian External Quality Assessment Scheme.

Assurance, Health Care Reference Standards Surveys and Questionnaires Abstract: BACKGROUND: This study aimed to assess the state-of-the-art of antinuclear antibody (ANA) testing as practiced in the Belgian and ...

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