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Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
agent and incorporation into medicinal/vaccine development processes. To this end, a whitepaper on the guidance has been produced and disseminated for consultation to researchers, regulatory experts and ...
The role of methylation, DNA polymorphisms and microRNAs on HLA-G expression in human embryonic stem cells.
of early human developmental processes in normal and pregnancy-related disorders such as preeclampsia. Health Topics: Effectiveness and safety of vaccines, medicines and health products- Quality of ...
An application of mass spectrometry for quality control of biologicals: Highly sensitive profiling of plasma residuals in human plasma-derived immunoglobulin.
with Ig. The method is a convenient tool to better characterize Ig products after any plasma pool or manufacture process change, gaining insights in the product quality profile without any prior ...
Chemometrics and the identification of counterfeit medicines-A review.
of actual case studies dealing with verifying the authenticity of selected medicines supported by different chemometric approaches. In particular, a general data processing workflow is discussed with ...
Chromatographic impurity fingerprinting of genuine and counterfeit Cialis® as a means to compare the discriminating ability of PDA and MS detection.
by counterfeit medicines. Their quality, safety and efficacy cannot be guaranteed since no quality control is performed during and/or after the manufacturing process. Characterization of these products ...
Testing of complementarity of PDA and MS detectors using chromatographic fingerprinting of genuine and counterfeit samples containing sildenafil citrate.
Processing, Computer-Assisted Sildenafil Citrate Abstract: Counterfeit medicines are a global threat to public health. High amounts enter the European market, which is why characterization of these products is ...
The accuracy of guided surgery via mucosa-supported stereolithographic surgical templates in the hands of surgeons with little experience.
Volume 26, Issue 12, p.1489-94 (2015) Keywords: Adult Aged Clinical Competence Dental Implantation, Endosseous Dental Implants Female Humans Image Processing, Computer-Assisted Jaw, Edentulous Male middle ...
Application of the characteristic function to evaluate and compare analytical variability in an external quality assessment scheme for serum ethanol.
characteristic function is used to describe the relation between the target concentration and the EQA standard deviation, which is an essential part of the evaluation process. The characteristic function is also ...