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For this reason, pycnometric determination of the density has been for a long time the only approved reference method to determine the alcoholic strength in spirits and wines.
This study has been approved (reference number CP04/06/08) by a Spanish Regional Ethics Committee (CEICA) and consequently the study will be carried out in compliance with the Helsinki Declaration of Human Rights.
Biosimilar development involves an iterative, stepwise, target-directed approach resulting in a product that is highly similar to the approved reference biologic.
For a long time pycnometric determination of the density was the approved reference method to determine the alcoholic strength in spirits and wines.
The Joint Committee on Traceability in Laboratory Medicine database lists these as approved reference measurement procedures for serum 5MTHF and FA (40).
All positive samples were confirmed and typed by the National reference laboratory for animal TSEs of AFSSA Lyon using EU approved reference methods [ 22].
Unlike small molecule generic drugs that are identical to the licensed or approved reference drug, biosimilars are highly similar, but not identical, to the reference drug.
Specifically, only first-line management approved references to the Tea Party in the BOLO listing criteria before it was implemented.
This approach is based on evidence submitted by the biosimilar manufacturer 7, 14, 15 and includes analytical and clinical studies comparing the proposed biosimilar to an approved biologic reference product 14.
An approved IFCC reference method for measuring HbA1c, with a firm and reproducible correlation with NGSP values, is now available.
Invoices that do not reference an approved Oracle-generated purchase order number will initiate an audit.
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