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potența relativă
The Applicant should provide evidence based on sensitive clinical studies (preferably studies investigating the relative potency) that a 20% difference lacks of clinical relevance.
Solicitantul ar trebui să furnizeze dovezi bazate pe studii clinice sensibile (preferabil studii care investighează potenţa relativă) pentru ipoteza că o diferenţă de 20% nu are relevanţă clinică.
Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Potenta relativă prin test de potenţă la soareci, comparativ cu un vaccin de referinţă, care a fost dovedit eficace la ovine.
Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Potenţă relativă prin metoda in vitro, comparată cu un vaccin de referintă eficient la cai. Adjuvant
) Relative potency (RP) is determined by comparing the antibody level with the antibody level in the serum prepared with a reference batch of the vaccine that passed the challenge test on target animals according to the Ph.Eur.
) Potenţa relativă (RP) este deteminată prin comparaţie cu un preparat de referinţă, testat prin infecţie de control pe specia ţintă conform cerinţelor monografiei Farmacopeea Europene.
Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0 maximum RP* 3.75 Relative Potency (ELISA test) by comparison with a reference vaccine
PR minimă 1, 0 PR maximă 3, 75 Potenţa relativă (test ELISA), prin comparaţie cu un vaccin de referinţă
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