FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant provided in vitro data to demonstrate the in vitro equivalence between the test product and the reference product and presented justifications for the pooling of the data including a second pooling using the following grouped stages: Throat separately (oropharyngeal deposition and hence swallowed dose), Pooling 1: Stage 0, 1, and 2 (large non respirable particles deposited in upper airway, which can be ignored as clinically insignificant), Pooling 2: Stage 3, 4 and 5 (fine particle dose (FPD) between 1.1 and 4.5 µm, deposited on bronchi and predictive of the in vivo bronchodilator efficacy and of Cmax (early lung bioavailability)) and Pooling 3: Stage 6, 7, and Filter (reflects extra fine particles deposited in alveoli).
Maltese: Gerżuma separatament (depożizzjoni orofarinġeali u għaldaqstant id-doża miblugħa), Raggruppament 1: Stadju 0, 1, u 2 (partiċelli kbar mhux respirabbli depożitati fil-passaġġ tal-arja ta' fuq, li jistgħu ma jitqisux bħala klinikament mhux sinifikanti), Raggruppament 2: Stadju 3, 4 u 5 (doża ta' partiċella fina (FPD) bejn 1.1 u 4.5 µm, iddepożitati fuq il-bronki u ta' tbassir tal-effikaċja bronkodilatorja in vivo u s-Cmax (bijodisponibbiltà bikrija filpulmun)) u Raggruppament 3: Stadju 6, 7, u Filtru (jirrifletti partiċelli ekstrafini ddepożitati flalveoli).
English: Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgas-inhalation, Suspension
Maltese: Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgasinhalation, Suspension
English: Based on the draft OIP guideline, the Applicant initiated two parmacokinetic studies, both with a single dose administration of 800 µg salbutamol in healthy volunteers: studies 2007-59-DOS-5 (systemic safety study) and 2007-76-DOS-6 (pulmonary deposition study).
Maltese: Abbażi talabbozz tal-linja gwida OIP, l-Applikant beda żewġ studji farmakokinetiċi, it-tnejn b'għoti ta' doża singola ta' 800 µg salbutamol f'voluntiera f'saħħithom: studji 2007-59-DOS-5 (studju ta' sigurtà sistemika) u 2007-76-DOS-6 (studju ta' depożizzjoni pulmonari).
English: - the CHMP considered that a similar particle size distribution between the test and the reference product was demonstrated,
Maltese: - is-CHMP ikkunsidra li ntweriet distribuzzjoni ta' daqs tal-partiċella simili bejn il-prodott tat-test u dak ta' referenza,
English: The CHMP was of the opinion that the bioequivalence study (2207-59-DOS-5) demonstrated equivalency in safety profile when used without a spacer, as well as similar Cmax and Tmax values.
Maltese: IsCHMP kien tal-opinjoni li l-istudju ta' bijoekwivalenza (2207-59-DOS-5) wera ekwivalenza fil-profil ta' sigurtà meta użat mingħajr spejser, kif ukoll bħala valuri Cmax u Tmax simili.
English: Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a
Maltese: Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presción EFG
English: In absolute terms, the values outside the +/20% limit represent a negligible mean difference which is clinically irrelevant in the context of any overall potential increase in systemic exposure.
Maltese: F'termini assoluti, il-valuri barra l-limitu +/- 20% jirrappreżentaw differenza medja negliġibbli li hija klinikament irrelevanti fil-kuntest ta' xi żieda potenzjali totali fl-esponiment sistemiku.
English: a) The Applicant quoted the EMEA draft guideline on orally inhaled products (OIP) which offers the possibility to pool different stages of the Andersen Cascade Impactor.
Maltese: a) L-Applikant ikkwota l-abbozz tal-linja gwida tal-EMEA fuq prodotti inalati oralment (OIP) li joffri l-possibilità li stadji differenti tal-Andersen Cascade Impactor jiġu raggrupati.
English: The Applicant stated that for pharmacokinetic studies, equivalence is conventionally demonstrated by applying a +/- 20% limit for the 90% CI and therefore applied these limits to the FDP comparison, despite the recent EMEA guidance recommending +/- 15% limits for in vitro equivalence and +/- 20% limits for in vivo pharmacokinetic equivalence.
Maltese: L-Applikant iddikjara li għall-istudji farmakokinetiċi, l-ekwivalenza tintwera konvenzjonalment blapplikazzjoni ta' limitu ta' +/- 20% għal CI ta' 90% u għaldaqstant applika dawn il-limiti għat-tqabbil FDP, minkejja l-gwida reċenti tal-EMEA li tirrakkomanda limiti ta' +/- 15% għal ekwivalenza in vitro u limiti ta' +/- 20% għal ekwivalenza farmakokinetika in vivo.
English: - the CHMP concluded that the products are bioequivalent and that the benefit-risk ratio is positive,
Maltese: - is-CHMP ikkonkluda li l-prodotti huma bijoekwivalenti u li l-proporzjon benefiċċju-riskju huwa wieħed pożittiv,
English: The in-vitro data without spacer suggests inferiority in stages 0, 1, 2 and 3 and similarity for stages 4, 5, 6, 7 and the filter stage, which suggests a similar Cmax and a superior AUC or similar AUC if the small amount in stages 0/1/2 were negligible.
Maltese: Id-dejta in-vitro mingħajr spejser tissuġġerixxi inferjorità fi stadji 0, 1, 2 u 3 u xebh fl-istadji 4, 5, 6, 7 u l-istadju tal-filtru, li jissuġġerixxi Cmax simili u AUC superjori jew AUC simili jekk l-ammont żgħir fl-istadji 0/1/2 kellu jkun negliġibbli.
English: The Applicant should provide evidence based on sensitive clinical studies (preferably studies investigating the relative potency) that a 20 % difference lacks of clinical relevance.
Maltese: L-Applikant għandu jipprovdi evidenza bbażata fuq studji kliniċi sensittivi (preferabbilment studji li jinvestigaw il-qawwa relattiva) li differenza ta' 20 % fiha nuqqas ta' relevanza klinika.
English: The CHMP was of the opinion that based on the totality of the data submitted, including the data from the pulmonary deposition study (Study 2007-76-DOS-6), a similar particle size distribution between the test and the reference product could be demonstrated.
Maltese: Is-CHMP kien tal-opinjoni li abbażi tad-dejta kollha ppreżentata, inkluża d-dejta mill-istudju ta' depożizzjoni pulmonari (Studju 2007-76-DOS-6), tista' tintwera distribuzzjoni ta' daqs tal-partiċella simili bejn il-prodott tat-test u dak tar-referenza.
English: Sabumalin is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/spray, with HFA 134a as propellant.
Maltese: Sabumalin huwa inalatur aerosol ta' doża mkejla li fih formulazzjoni ta' sospensjoni ta' salbutamol sulfat 100 µg/sprej, b'HFA 134a bħala propellent.
English: The new formal protocol of the performed retrospective analysis and the new final report on the in vitro data indicated that the 90% CI remained outside the 15% or 20% acceptance range for stage 0, stage 1 and stage 2 and within the 20% CI but outside the 15% CI for stage 3 the 90% CI.
Maltese: Il-protokoll formali l-ġdid tal-analiżi retrospettiva magħmula u r-rapport finali l-ġdid dwar id-dejta in vitro indika lis-CI ta' 90% baqa' barra mill-medda ta' aċċettabilità ta' 15% jew 20% għall-istadju 0, stadju 1 u stadju 2 u fi ħdan is-CI ta' 20% iżda barra s-CI ta' 15% għall-istadju 3 is-CI ta' 90%.
English: Particles >4.5 µm are swallowed and contribute by negligible amount to the early systemic bioavailability (as Cmax) and peak adverse events of inhaled salbutamol.
Maltese: Il-partiċelli >4.5 µm jinbelgħu u jikkontribbwixxu b'ammont negliġibbli għallbijodisponabbilità sistemika bikrija (bħala Cmax) u episodji avversi massimi ta' salbutamol inalat.
English: According to the Applicant, a comparison of the results for the different approaches (individual stages 3, 4 and 5 versus pooled stages 3/4/5) demonstrates that except for stage 3 (below the -15% limit), both approaches lead to comparable results.
Maltese: Skont l-Applikant, tqabbil tar-riżultati għall-approċċi differenti (stadji individwali 3, 4 u 5 meta mqabbla ma' stadji raggruppati 3/4/5) juri li għajr għall-istadju 3 (taħt il-limitu -15%), iż-żewġ approċċi jwasslu għal riżultati komparabbli.
English: - the CHMP considered that Sabumalin and the reference product possess the same systemic safety profile, as demonstrated by the bioequivalence in systemic levels (AUC and Cmax),
Maltese: - is-CHMP ikkunsidra li Salbumalin u l-prodott ta' referenza għandhom l-istess profil ta' sigurtà sistemika minħabba li ntweriet il-bijoekwivalenza f'livelli sistemiċi (AUC u Cmax),
English: The Applicant considered that the results from study 2007-59-DOS-5 demonstrate bioequivalence in terms of rate and extent of the total systemic absorption of inhaled salbutamol.
Maltese: L-Applikant ikkunsidra li r-riżultati mill-istudju 2007-59-DOS-5 juru bijoekwivalenza f'termini tarrata u l-medda tal-assorbiment sistemiku totali ta' salbutamol inalat.
English: b) The Applicant indeed considered that it is the amount of respirable particles <4.7 µm that will ultimately determine bronchodilator efficacy, particularly for stages 3/4/5 (i.e. particle size 1.1-4.7 µm) which correspond to bronchial deposition where the airway smooth muscle beta-2 adrenoceptors are located.
Maltese: b) L-Applikant tabilħaqq ikkunsidra li l-ammont ta' partiċelli respirabbli <4.7 µm li fl-aħħar millaħħar jiddeterminaw l-effikaċja bronkodilatorja, b'mod partikolari għall-istadji 3/4/5 (jiġifieri daqs ta' partiċella 1.1- 4.7 µm) li tikkorrespondi ma' depożizzjoni bronkjali fejn jinsabu r-riċetturi beta-2 adrenerġiċi tal-muskolatura lixxa tal-passaġġ tal-arja.
English: Moreover, the in vitro data for larger particle deposition together with the total (lung +gut) systemic bioavailability as AUC show evidence of overall systemic equivalence.
Maltese: Barra minn hekk, id-dejta in vitro għad-depożizzjoni ta' partiċelli ikbar flimkien ma' bijodisponibilità sistemika totali (pulmun u musrana) bħala AUC juru evidenza ta' ekwivalenza sistemika totali.
English: The Applicant was able to present data from the pulmonary deposition study (Study 200776-DOS-6) were presented and interpreted and this new in vitro data (without spacer in a normal and humid environment and with spacer in a normal environment) suggested a similar particle size distribution between the test and the reference product.
Maltese: L-Applikant kien kapaċi jippreżenta dejta mill-istudju ta' depożizzjoni pulmonari (2007-76-DOS-6) li ġiet ippreżentata u interpretata u din id-dejta ġdida in vitro (mingħajr spejser f'ambjent normali u umdu u bi spejser f'ambjent normali) issuġġeriet distribuzzjoni simili ta' daqs ta' partiċella bejn il-prodott tat-test u ta' referenza.
English: The Applicant also included results from a comparative pharmacokinetic study evaluating systemic safety, which demonstrates equivalence and considered that the equivalence of the Cmax values as identified from the systemic safety study supports the prediction of equivalent lung bioavailability and equivalent lung deposition.
Maltese: L-Applikant inkluda wkoll riżultati minn studju farmakokinetiku ta' tqabbil li evalwa s-sigurtà sistemika, li juri l-ekwivalenza u kkunsidra li l-ekwivalenza tal-valuri Cmax kif identifikati mill-istudju ta' sigurtà sistemika jappoġġjaw it-tbassir ta' bijodisponibilità tal-pulmun ekwivalenti u depożizzjoni fil-pulmun ekwivalenti.
English: The fine particle dose ratio was 1.01 and the corresponding confidence interval was 0.97 - 1.04 and the data therefore clearly demonstrate that the expected spacer effect is identical for test and reference product.
Maltese: Il-proporzjon ta' doża ta' partiċelli fini kien 1.01 u l-intervall ta' kunfidenza korrispondenti kien 0.97 - 1.04 u għaldaqstant, iddejta turi b'mod ċar li l-effett mistenni tal-spejser huwa identiku għall-prodott tat-test u tar-referenza.
English: Based on the submitted expert report from study 2007-76-DOS-6, the Applicant concluded that “the presented in vitro data for fine particle dose and the in vivo data for lung bioavailability as Cmax clearly point to the presence of therapeutic equivalence within the 20% limits for both airway and systemic beta-2 adrenoceptor mediated peak effects.
Maltese: Abbażi tar-rapport espert sottomess mill-istudju 2007-76-DOS-6, l-Applikant ikkonkluda li “d-dejta in vitro ppreżentata għaddoża ta' partiċelli fini u d-dejta in vivo għall-bijodisponibilità għall-pulmun minħabba li Cmax jipponta b'mod ċar lejn il-preżenza ta' ekwivalenza terapewtika fi ħdan il-limiti 20% kemm għalleffetti massimi tal-passaġġi tal-arja kif ukoll għall-effetti massimi sistemiċi medjati minn riċetturi beta-2 adrenerġiċi.
English: Question 5 - The Applicant should justify why the product is considered equivalent when the particle size comparison with spacer is not able to demonstrate equivalence in the pool of throat + stage 0 + stage 1, pooled as desired by the Applicant with the 20 % acceptance range and pool of stages 2 + 3, as desired by the Applicant, with the 15 % acceptance range, mainly because the sample size of this comparison has not been calculated appropriately.
Maltese: Mistoqsija 5 - L-Applikant għandu jiġġustifika għaliex il-prodott huwa kkunsidrat ekwivalenti meta ttqabbil tad-daqs tal-partiċella bl-ispejser mhuwiex kapaċi juri ekwivalenza fir-raggruppament ta' gerżuma + stadju 0 + stadju 1, raggruppat kif mixtieq mill-Applikant bil-medda ta' approvazzjoni ta' 20 % u raggruppament ta' stadji 2 + 3, kif mixtiqin mill-Applikant,bil-medda ta' approvazzjoni ta' 15 %, prinċiplament peress li d-daqs tal-kampjun ta' dan it-tqabbil ma ġiex ikkalkulat b'mod xieraq.
English: The in vivo bioequivalence study shows an equivalent but statistically significant superiority for the test product for Cmax and a shorter Tmax, indicating that the test product has a slightly higher peripheral deposition.
Maltese: L-istudju ta' bijoekwivalenza in vivo juri superjorità ekwivalenti iżda statistikament sinifikattiva għall-prodott tattest għal Cmax u Tmax iqsar, li jindika li l-prodott tat-test għandu depożizzjoni periferiku xi ftit ogħla.
English: The amount of salbutamol impacted on stages comprising throat/0/1/2 are non respirable (i.e. >4.7 µm) and will correspond to larger particles deposited on the oropharynx (throat stage) and upper airway (stages 0/1/2).
Maltese: L-ammont ta' salbutamol li kellu impatt fuq listadji inkluż il-gerżuma /0/1/2 mhumiex respirabbli (jiġifieri >4.7 µm) u jikkorrispondu għal partiċelli ikbar iddepożitati fl-orofarinġi (stadju tal-gerżuma) u l-passaġġ tal-arja tan-naħa ta' fuq (stadji 0/1/2).
English: Prophylaxis of exercise and allergen induced asthma.” The Applicant submitted pharmaceutical and clinical efficacy and safety documentation, but a number of Member States did not consider the product to be approvable based on the submitted in vitro data only.
Maltese: L-applikant ippreżenta dokumentazzjoni tal-effikaċja u sigurtà farmaċewtika u klinika, iżda numru ta' Stati Membri ma kkunsidrawx li lprodott huwa approvat abbażi tad-dejta in vitro ppreżentata.
English: For stages representing extra fine particles (<1.1µm), equivalence was also shown, with the exception of deposition in the filter stage (outside +15% but within +20%).
Maltese: Għall-istadji li jirrappreżentaw partiċelli ekstrafini (<1.1µm), intweriet ukoll l-ekwivalenza, bl-eċċezzjoni ta' depożizzjoni fl-istadju tal-filtru (barra +15% iżda fi +20%).
English: Salbutamol/ Sandoz
Maltese: Salbutamol/Sandoz 100 µg/doża
English: Pharmacokinetic and pharmacodynamic studies have shown that the swallowed fraction from oropharyngeal depositions contributes a negligible amount to the early systemic bioavailability and peak adverse effects of inhaled salbutamol and that there is only negligible direct absorption from the oropharynx.
Maltese: Studji farmakokinetiċi u farmakodinamiċi wrew li l-frazzjoni miblugħa minn depożizzjonijiet orofarinġeali tikkontribbwixxi ammont negliġibbli għall-bijodisponibbiltà sistemika bikrija u effetti avversi massimi ta' salbutamol inalat u li hemm biss assorbiment dirett negliġibbli mill-orofarinġi.
English: The Applicant responded to the outstanding issues during an Oral Explanation held during the November CHMP meeting.
Maltese: L-Applikant irrisponda għall-kwistjonijiet pendenti waqt Spjegazzjoni Orali li saret waqt il-laqgħa tasCHMP ta' Novembru.
English: SalbuLEK
Maltese: L-Isvezja
English: The Applicant stated that the presented in vitro data can be predictive of pharmacokinetic bioequivalence for Cmax and for peak airway and systemic beta-2 adrenoceptor mediated responses, which are mainly determined by lung bioavailability.
Maltese: LApplikant iddikjara li d-dejta ppreżentata in vitro tista' tkun ta' tbassir għall-bijoekwivalenza farmakokinetika għas-Cmax u għar-risponsi massimi tal-passaġġi tal-arja u sistemiċi medjati minn riċettur beta-2 adrenerġiku (adrenoceptor), li huma prinċiplament iddeterminati mill-bijodisponibbiltà tal-pulmun.
English: Following an additional request for clinical spacer studies, the Applicant decided to extend the previously submitted in vitro equivalence study with spacer use, including 7 generic and 10 reference batches (compared to 2 and 3 previously).
Maltese: Wara talba addizzjonali għall-istudji kliniċi tal-ispejser, l-Applikant iddeċieda li jestendi l-istudju ta' ekwivalenza bl-użu tal-ispejser in vitro li kien diġà ġie ppreżentat, inklużi 7 lottijiet ġeneriċi u 10 ta' referenza (mqabblin ma' 2 u 3 ta' qabel).
English: The data clearly shows that the spacer induces a significant depletion of large particles in the throat and an increase in fine particle dose (< 5 µm particles), with the confidence intervals for the single impactor stages within the +/- 20% limit, except for stage 0.
Maltese: Id-dejta turi b'mod ċar li l-ispejser jinduċi tnaqqis sinifikanti ta' partiċelli kbar fil-gerżuma u żieda fid-doża ta' partiċelli fini (partiċelli < 5 µm), blintervalli ta' kunfidenza għall-istadji ta' impactor singolu fi ħdan il-limitu ta' +/- 20%, ħlief għallistadju 0.
English: The pharmacokinetic bioequivalence study also confirmed that both products possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown.
Maltese: L-istudju ta' bijoekwivalenza farmakokinetika kkonferma wkoll li ż-żewġ prodotti għandhom l-istess profil ta' sigurtà sistemika minħabba li ntweriet il-bijoekwivalenza fil-livelli sistemiċi (AUC u Cmax).
English: The Applicant concluded that the in vitro data and the negligible clinical relevance of the differences detected were supported by the provided in vivo study.
Maltese: L-Applikant ikkonkluda li d-dejta in vitro u r-relevanza klinika negliġibbli tad-differenzi kienet appoġġjata mill-istudju in vivo pprovdut.
English: The
Maltese: b.
English: In addition, the Applicant provided a consolidated final protocol consisting of all single protocols retrospectively combined and a retrospectively combined report from all the corresponding study reports including the raw data and study results.
Maltese: Barra minn hekk, l-Applikant ipprovda protokoll finali kkonsolidat li jikkonsisti mill-protokolli singoli kollha kkumbinati retrospettivament u rapport ikkumbinat retrospettivament mir-rapporti tal-istudji korrespondenti kollha inkluż dejta mhux ipproċessata u riżultati tal-istudju.
English: Therefore, the different cloud size/shape or the humid environment that exists in the respiratory tree may be relevant.
Maltese: Għaldaqstant, id-daqs/forma tas-sħaba differenti jew l-ambjent umdu li jeżisti fis-siġra respiratorja jista' jkun rilevanti.
English: The Applicant considered that the widening of the limits to +/- 20% is justifiable and demonstrated that the results obtained fall within the +/- 15% range, except for stage 3.
Maltese: L-Applikant ikkunsidra li ttwessigħ tal-limiti għal +/- 20% huwa ġustifikabbli u wera li r-riżultati miksubin jaqgħu fil-medda ta' +/- 15%, ħlief għall-istadju 3.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Maltese: ANNESS I LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, IL-QAWWA TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI
English: The Applicant provided raw data obtained under humid condition clearly demonstrating that the aerodynamic characteristic of salbutamol sulphate particles do not change under humid conditions.
Maltese: L-Applikant ipprovda dejta mhux ipproċessata miksuba f'kundizzjonijiet umdi li turi b'mod ċar li lkaratteristika ajrudinamika ta' partiċelli ta' salbutamol sulfat ma tinbidilx f'kundizzjonijiet umdi.
English: The CHMP noted the position of the Applicant but considered that this oversimplifies the effect of all generated particles on the respiratory and alimentary tract and that it is difficult to define the role of the individual stages in terms of safety and efficacy, effects such as differences in breathing patterns, aerosol velocity in entering the airways and the shape of the plume must be taken into account.
Maltese: Is-CHMP innota l-pożizzjoni tal-Applikant iżda kkunsidra li din tissimplifika żżejjed l-effett talpartiċelli kollha ġġenerati fuq il-passaġġ respiratorju u alimentari u li huwa diffiċli biex wieħed jiddefinixxi r-rwol tal-istadji individwali f'termini ta' sigurtà u effikaċja, ta' effetti bħalma huma differenzi fil-patterns tat-teħid tan-nifs, veloċità tal-aerosol waqt id-dħul fil-passaġġi tal-arja u l-forma tas-sħaba għandhom jiġu kkunsidrati.
English: This difference is not expected to be of clinical relevance and the two products are therefore considered to exhibit an equivalent bronchodilator response.
Maltese: Din id-differenza mhijiex mistennija li tkun ta' relevanza klinika u ż-żewġ prodotti huma għaldaqstant ikkunsidrati li jeżibixxu rispons bronkodilatur ekwivalenti.
English: Although the claim of the Applicant that the PK bioequivalence study demonstrated equivalence without spacer was endorsed, the CHMP did not support the assumption that the data with the use of a spacer would provide the same evidence of equivalence and therefore considered that a PK study with a spacer is mandatory.
Maltese: Fl-opinjoni tas-CHMP, din id-differenza żgħira mhijiex mistennija li tkun klinikament sinifikanti u ma jidhirx li huwa meħtieġ studju farmakodinamiku.
English: The supplied data on particle size distribution did not allow the prediction of the lung deposition pattern affecting clinical efficacy and safety and the aerodynamic particle size distribution differed significantly between the two products.
Maltese: Id-dejta fornuta dwar iddistribuzzjoni tad-daqs tal-partiċella ma ppermettitx li jsir it-tbassir tal-mod ta' depożizzjoni filpulmun u dan affettwa l-effikaċja u s-sigurtà klinika u d-distribuzzjoni ajrudinamika tad-daqs talpartiċella varjat ferm bejn iż-żewġ prodotti.
English: The pharmacokinetic bioequivalence data also confirmed that Sabumalin and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown, when used with or without a spacer.
Maltese: Id-dejta ta' bijoekwivalenza farmakokinetika kkonfermat ukoll li Salbumalin u l-prodott ta' referenza għandhom l-istess profil ta' sigurtà sistemika minħabba li ntweriet il-bijoekwivalenza f'livelli sistemiċi (AUC u Cmax), meta użati bi jew mingħajr spejser.
English: Question 7 - In order to complete the comparative study between the reference and the test products, a comparative repriming study after storage at lying position (0°C) (initial stage of can life and partially emptied can) should be carried out to confirm their similarity of behaviour.
Maltese: Mistoqsija 7 - Sabiex jintemm l-istudju ta' tqabbil bejn il-prodotti ta' referenza u tat-test, għandu jsir studju ta' riattivazzjoni (repriming) ta' tqabbil wara ħażna fil-pożizzjoni mimduda (0°C) (stadju inizjali tal-ħajja tal-bott u tal-bott parzjalment żvujtat) biex jikkonferma x-xebh tal-imġiba tagħhom.