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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

and to 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 ...

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

97 (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 ...

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

availability of 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 ...

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

Skottheim 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 issues in ...

Biotech Rice: Current developments and future detection challenges in food and feed chain

choice, regulatory frameworks were established in many countries around the world, such as in Europe. Their implementations, including detection systems usually based on qPCR, are becoming complex and ...

Regulatory Position on Specification Settings

Countries, PDA Europe, Issue PDA Europe, Berlin, Germany (2015) Keywords: challenge CHALLENGES conference Countries developing Developing Countries Europe ON Regulatory vaccine vaccines WHO Health Topics:  ...

Regulatory T-cell development and function are impaired in mice lacking membrane expression of full length intercellular adhesion molecule-1.

Gene Expression Intercellular Adhesion Molecule-1 Lymphocyte Activation mice Mice, Transgenic T-Lymphocyte Subsets T-Lymphocytes, Regulatory Thymocytes Abstract: To further investigate the contribution ...

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