Although there is no harmonized standard for measuring therapeutic response, physicians generally use two methods: (1) response criteria or cut-off values determined by auxology or clinical outcomes [ 2, 3] or (2) prediction models based on large data sets from patient registries [ 1, 4].
Under NTR support, we have developed the basic outline of the 510(k) for the instrumentation, as well as a CE European Commissionn harmonized standards) mark for its translation in Europe.
No globally harmonized standards or statistically representative sampling schemes and testing protocols exist for surveillance to inform a regulatory and legal response against those who knowingly and deliberately distribute falsified and substandard medicines.
This will create a large market place with harmonized standards, allowing carmakers to maximize sales over a larger territory.
PACA and other groups are working to support development of harmonized standards in Africa, but selecting a shared value is a complex and arduous prospect.
These assays were developed and validated, to be run simultaneously with the same PCR program, according a harmonized standard procedure described in Barbau-Piednoir et al. (2013).
This can be improved by building a network of interacting Expert Centres and implementing harmonized standard operating procedures (SOPs), common certification and accreditation procedures, use of common reference materials and regular participation in ring trials.
The paper proposes an analysis of the test settings imposed by the actual MID-harmonized standards, regarding the electric energy metering.
There also should be one harmonized set of international standards for acceptable levels of potential contaminants in food and feed products as well as universal methods of detection, prevention, and containment.
There are three goals: to enable open standards for interoperability of technology platforms for managing and sharing genomic and clinical data, to provide guidelines and harmonized procedures for privacy and ethics internationally, and to engage stakeholders to encourage responsible sharing of data and of methods.
