https://www.edqm.eu/sites/default/files/medias/fichiers/session_1_regulatory_aspects_part_1.pdf

Several institutions working on biological reference standards. • Biosimilar principle: reduction of non-clinical and clinical data package, with possibility of ...

https://www.sigmaaldrich.com/analytical-chromatography/analytical-standards/certified-reference/pharmaceutical-secondary.html

The FDA, USP and EP all recognize the use of secondary standards or working standards that are established with reference to the corresponding primary ...

https://en.wikipedia.org/wiki/Standard_(metrology)

Working standards and certified reference materials used in commerce and industry have a traceable relationship to the ...

https://www.slideshare.net/bhavanavedantam/reference-standards-in-pharmaceutical-industries

Jan 28, 2014 ... This presentation is brief introduction about reference standards that are ... Reference Standards (ARS)/ Primary Standard Working / Secondary .... the difference in energy (heat flow) between reference DSC and sample.

https://www.nibsc.org/standardisation/working_standards.aspx

These secondary standards may be national standards, regional standards or working reference materials used routinely in the laboratories of manufacturers, ...

https://www.usp.org/frequently-asked-questions/reference-standards

Get answers to frequently asked questions about USP's Reference Standards.

http://www.usp.org/reference-standards

Your confidence in your work is bolstered by your confidence in your standards. USP establishes primary standards for ensuring quality in pharmaceutical ...

http://apps.who.int/medicinedocs/documents/s21438en/s21438en.pdf

national standards, and not to the working standards of manufacturers or other laboratories. However, in principle, secondary reference standards prepared by ...

https://www.horizondiscovery.com/reference-standards/what-are-reference-standards

The Reference Standard is a universal reference material that performs equally and reproducibly between platforms, laboratories, operators and assays.

http://lab-training.com/2014/07/01/necessary-revalidate-working-standards/

Jul 1, 2014 ... Analysis results are always reported against working standards which have been validated against certified reference materials. A certified ...