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Résultats de la recherche - 25 results

Identification and characterization of inorganic food additives and pearlescent pigments in sprays for food decoration by STEM-EDX

mixtures, characterisation of the fraction of small particles, including the particle size distribution, is needed for each single constituent or each component in the mixture2. This is challenging for ...

Regulatory expectations on the use of vaccine reference standards for maintaining product quality.

Publication Type: Scientific poster, presentation or proceeding Authors: Wim Van Molle Source: Maintaining the Quality of Vaccines through the Use of Standards: Current Challenges and Future ...

Rational arguments for regulatory acceptance of consistency testing: benefits of non-animal testing over release testing of vaccines.

techniques to measure critical quality attributes. However, introduction of in vitro alternatives to replace in vivo release assays of authorized vaccines is challenging. AREAS COVERED: This report describes ...

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

classified differently by various jurisdictions. Indeed, considerations for challenge agent manufacturing vary between countries due to differences in regulatory oversight, the categorization of the challenge ...

Development of a “Freeze-Pour” Sample Preparation Method for the GC Analysis of Semivolatile Flavouring Chemicals Present in E-cigarette Refill Liquids

comply with the notification requirements of the EU Tobacco Product Directive, the EU member state regulatory authorities need information about the exact composition of the e-liquids and their emissions. ...

Estimation of the Uncertainties Related to the Measurement of the Size and Quantities of Individual Silver Nanoparticles in Confectionery.

Single particle ICP-MS Abstract: E174 (silver) is a food additive that may contain silver nanoparticles (AgNP). Validated methods are needed to size and quantify these particles in a regulatory context. ...

Occurrence and identification of spore-forming bacteria in skim-milk powders

(2019) Abstract: The different customer and regulatory specifications for mesophilic and thermophilic aerobic and anaerobic spore numbers in skim-milk powder, in addition to some specifications on specific ...

Screening for nanoparticles in complex matrices within a regulatory framework: are we there yet?

products and preparation of a stable particle dispersion, proved to be a challenging step. The precision (repeatability and intermediate precision) of the selected methodology was determined for both the ...

Genome Editing in Agriculture: Methods, Applications, and Governance—A paper in the series on The Need for Agricultural Innovation to Sustainably Feed the World by 2050

land and water caused by global population growth, as well as the challenges climate change poses to agriculture, genome editing for crop and livestock improvement is garnering increasing attention. This ...

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).

I Skottheim Rusten Source: CPT Pharmacometrics Syst Pharmacol, Volume 6, Issue 7, p.418-429 (2017) Abstract: Inadequate dose selection for confirmatory trials is currently still one of the most challenging ...

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