bioequivalent oor Nederlands
bioequivalent
en
Describing the equivalence of multiple formulations of a drug in terms of bioavailability
Vertalings in die woordeboek Engels - Nederlands
bio-equivalent
nl
een biologisch vergelijkbare stof met dezelfde kracht en uitwerking.
In addition, the generic must be bioequivalent with the reference product.
Daarnaast dient het generieke geneesmiddel bio-equivalent te zijn met het referentiegeneesmiddel.
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Voorbeelde moet herlaai word.
(b) 'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
Ik vind dit lied niksEurLex-2 EurLex-2
Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine
Nee, nog niet geflashtEMEA0.3 EMEA0.3
How can such a high degree of non-bioequivalence between herbal products and therapeutic indications guarantee public safety?
Waarom is die parkeerknul nog niet terug met m' n Porsche?not-set not-set
Bioavailability/bioequivalence
Nee Telly blijf daar!EurLex-2 EurLex-2
In addition, elements already assessed in the framework of the marketing authorisation process (quality, safety and efficacy, including bioequivalence) may not be reassessed in the framework of pricing and reimbursement procedures.
Stel je eens voor, een school zonder gepestEurLex-2 EurLex-2
(b) bioavailability studies cannot be used to demonstrate bioequivalence with the reference veterinary medicinal product, or
We moeten een vliegtuig halenEurLex-2 EurLex-2
However, in order to cover all generic medicinal products, including biotherapies, it is necessary to introduce the concept of biosimilarity in addition to bioequivalence.
De personeelskosten omvatten het geïndexeerde bruto loonbedrag en de werkgeverslasten en andere voordelen die zijn bepaald door het Collegenot-set not-set
(b) bioavailability studies cannot be used to demonstrate bioequivalence with the reference veterinary medicinal product; or
We kunnen overal heen gaan, ik heb geldnot-set not-set
Justification for not submitting a new bioequivalence study according to the current Note for Guidance on The Investigation of Bioavailability and Bioequivalence.
Prima, rustig aanEurLex-2 EurLex-2
Appropriate bioavailability studies shall be undertaken to establish bioequivalence
warmtekrachtkoppelingseenheid: een eenheid die in de warmtekrachtkoppelingsmodus kan werkenoj4 oj4
25 It should be noted in that regard that, according to the minutes of the meeting of the Council in December 1986 at which Directive 87/21 was adopted, the criteria determining the concept of essential similarity between medicinal products are that they have the same qualitative and quantitative composition in terms of active principles and the same pharmaceutical form, and, where necessary, bioequivalence of the two products has been established by appropriate bioavailability studies.
Ik ga terug naar Rusland...... tot Terek Murad in de cel of in het graf wegrotEurLex-2 EurLex-2
In a pharmacokinetic study in HIV-# infected patients, the steady state pharmacokinetic parameters of abacavir, lamivudine and zidovudine were similar when either Trizivir alone or the combination tablet lamivudine/zidovudine and abacavir in combination were administered, and also similar to the values obtained in the bioequivalence study of Trizivir in healthy volunteers
Herinner u, o Heer, Uw dienares Mary KarrasEMEA0.3 EMEA0.3
In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.
Kennelijk ongegrond beroep’EurLex-2 EurLex-2
(b) 'generic medicinal product' shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
Belangrijker is... dat ik ook word opgeofferd.En jij loopt ook ' n mooie kansEurLex-2 EurLex-2
Amendment 14 Proposal for a directive Recital 14 Text proposed by the Commission Amendment (14) The quality, safety and efficacy of medicinal products, including the bioequivalence of generic medicinal products with the reference product, are ascertained in the framework of marketing authorisation procedures.
Ik had me niet door Driscoll moeten laten overhalen het aan de FBI te gevennot-set not-set
In addition, an assessment of bioavailability shall be undertaken where necessary to demonstrate bioequivalence for the medicinal products referred to in Article #)(a
Jij bent Japaneurlex eurlex
In the framework of pricing and reimbursement decisions, Member Statesthe competent authorities shall not re-assess the essential elements on which the marketing authorisation is based, including thesuch as quality, safety, efficacy or, bioequivalence of the medicinal product, biosimilarity or criteria for orphan designation. 1a.
Wat wil je dan?not-set not-set
b) generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition in active principles and the same pharmaceutical form, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability tests.
Zo het bureau in de loop der stemverrichtingen beslist de plaats van de stempel te wijzigen, gaat het over tot een nieuwe loting, mits het nummer van het reeds benuttigd vakje van kant te laten als het weer mocht uitkomenEurLex-2 EurLex-2
‘... a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
Wanneer een benadeelde persoon in rechte treedt tegen diegene die hij aansprakelijk acht voor de door hem geleden schade en wanneer de verzekeraar van de oorspronkelijke gedaagde, door in het geding tussen te komen, naar aanleiding van hetzelfde feit, van de oorspronkelijke eiser de betaling van een bedrag vordert, vertoont die tussenkomst zulk een gelijkenis met een tegenvordering dat het niet in redelijkheid verantwoord is ze ten opzichte van een dergelijke vordering verschillend te behandelenEurLex-2 EurLex-2
35 – Two medicinal products are bioequivalent if they are pharmaceutically equivalents or alternatives and if their bioavailability (level and speed) after administration, in the same molar dose, is so similar that their effects both from the point of view of their efficacy and from that of their safety are essentially the same (see The Rules governing medicinal products in the European Union, EudraLex, Vol. 3C, Guidelines on medicinal products for human use – Efficacy, 1998 Edition, p.
INVESTERINGEN IN ONROERENDE ZAKEN, HUUR VAN GEBOUWEN EN BIJKOMENDE KOSTENEurLex-2 EurLex-2
The alendronate component in the ADROVANCE (#mg/# IU) combination tablet is bioequivalent to the alendronate # mg tablet
Verwerende partij: Commissie van de Europese GemeenschappenEMEA0.3 EMEA0.3
Where bioequivalence is not fully demonstrated, conformity of the withdrawal period with the MRL has to be demonstrated
de heer Robert Hotyatoj4 oj4
bioavailability studies cannot be used to demonstrate bioequivalence with the reference veterinary medicinal product; or
juli # Datum van laatste herniewingEurlex2019 Eurlex2019
Eli Lilly had accepted that Prozac liquid was not essentially similar to Prozac capsules, by reason of its different pharmaceutical form, and had provided bridging data to demonstrate that the products were bioequivalent.
Ik zei toen ten overstaan van de hele familie:' Dat is ongepast. 'EurLex-2 EurLex-2
Two products are bioequivalent to one another when they have the same bioavailability, that is, they are absorbed into the body and transferred to the site of action at the same rate and to the same extent.
Je hebt de doden binnengelatenEurLex-2 EurLex-2
204 sinne gevind in 9 ms. Hulle kom uit baie bronne en word nie nagegaan nie.