Примери за използване на Therapeutic equivalence на Английски и техните преводи на Български
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But because therapeutic equivalence has been demonstrated in adults,
demonstrated therapeutic equivalence to the originator, indicated similar local availability of budesonide
During the procedure it was concluded that therapeutic equivalence to the reference product was demonstrated in adults,
The therapeutic equivalence of alendronate 70 mg once weekly(n=519)
The therapeutic equivalence of alendronate in tablets for weekly administration(n= 519)
The therapeutic equivalence of once weekly alendronate 70 mg(n=519)
The therapeutic equivalence of once weekly FOSAMAX 70 mg(n=519)
The therapeutic equivalence of alendronate 70 mg once weekly(n= 519)
Alendronate studies The therapeutic equivalence of alendronate once weekly 70 mg(n=519)
as long as these differences do not affect the therapeutic equivalence between the reference and the test products.
that it was therefore difficult to conclude on therapeutic equivalence.
The CHMP concluded that the applied product had not shown enough similarity to the reference product to establish therapeutic equivalence with regards to efficacy and safety
the Applicant stated that the results from a therapeutic equivalence study did not provide any indication of differences in systemic exposure
locally acting products containing known constituents(EMA CPMP/EWP/239/95), clinical data are in principle necessary to establish therapeutic equivalence between two products.
The present referral was triggered on the grounds that the waiver for clinical studies is not in line with the“Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied,
the CHMP concluded that therapeutic equivalence has not been demonstrated and as such the benefit risk balance for these hybrid products was considered negative.
Furthermore, the safety profile of Budesonide Sandoz in the therapeutic equivalence trial was similar to that of both the originator product
therefore clinical studies for demonstrating therapeutic equivalence can be waived in accordance with the scientific guidelines(EMEA/CHMP/QWP/49313/2005 Corr.
as long as it is demonstrated that these differences do not affect the therapeutic equivalence between the reference and the test product.
The dose and schedule for the indications is appropriate, based on the available data with pantoprazole 40 mg p.o. and the pharmacodynamic and therapeutic equivalence of pantoprazole 40 mg i.v.