Search results - 17 results

The GEONs API-fingerprint program: Tackling falsifications of APIs

since the quality and quantity of the API might be within the current standards. Instead, methods that allow distinction of API samples, according to their source are needed. Within the General European ...

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

Publication Type: Scientific poster, presentation or proceeding Authors: L. Tesolin Source: CASS Bioassays 2020, Gaithersburg PA, USA, Sciensano, Gaithersburg, PA, USA (2020) Keywords: in vivo OMCL reference qualification reference vaccine Health Topics:  ...

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, ...

Comparative Evaluation of Lumpy Skin Disease Virus-Based Live Attenuated Vaccines.

purpose of this study to compare five homologous live attenuated LSDV vaccines (LSDV LAV) in a standardized setting. All five LSDV LAV s studied were able to protect against a challenge with virulent LSDV. ...

CBD oils on the Belgian market: A validated MRM GC-MS/MS method for routine quality control using QuEChERS sample clean up

however, encountered for routine analyses due to the matrix complexity, high cost of cannabinoid standards and low Δ9- THC concentrations. An oily matrix could cause technical damages to analytical ...

Chemical and toxciological characterization of e-liquid cigarettes

information on their genotoxicity was present. For four of these flavourings, a commercial standard was available and thus could be tested in vitro using an Ames- and micronucleus test. One of the four ...

Analytical validation of tests in laboratories of anatomic pathology: a Belgian population-based study

Laboratory of anatomic pathology · Test validation · Standard operating procedure · Validation report Health Topics:  Effectiveness and safety of vaccines, medicines and health products- Quality of medical ...

Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills

using the National Institute of Standards and Technology (NIST) research library, 436 individual components could be identified. Next, the genotoxic potential of these individual components was ...

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 ...

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