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61por Zecca, Ernesto, Manzoni, Andrea, Centurioni, Fabio, Farina, Alberto, Bonizzoni, Erminio, Seiler, Dan, Perrone, Tania, Caraceni, Augusto“…Bioequivalence was to be claimed if the 90% confidence interval of AUC(0,t) and C(max) ratios (test: reference) were within the acceptance range of 80–125% and 75–133%, respectively. RESULTS: The 90% confidence intervals of the AUC(0,t) ratio (116.3% [109.6, 123.4%]) and C(max) ratio (114.4% [105.8, 123.8%] were well included in the acceptance range and the C(max) ratio also met the narrower bounds of 80–125%. …”
Publicado 2015
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62por Abdel Raheem, Islam Ali, Abdul Razek, Amro, Elgendy, Abeer Abdelaziz, Saleh, Noha Mohamed, Shaaban, Mona Ibrahem, Abd El-Hady, Faten K“…ProE-loaded NPs exhibited accepted entrapment efficiency (>80) and prolonged release. In vitro cytotoxicity study confirmed the safety of ProE-loaded NPs. …”
Publicado 2019
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63por GolAli, Ensieh, Sistanizad, Mohammad, Salamzadeh, Jamshid, Haghighi, Mehrdad, Solooki, Mehrdad“…The most common recommendations were discontinuing antibiotics and changing from intravenous to oral therapy (35% and 22%). The acceptance rate was 80.2%. Rate of discrepancies from guidelines was compared between pre-intervention and two last months of intervention period which showed a significant reduction in antibiotic choosing (47%, P-value < 0.001), de-escalation (48%, P-value < 0.001), on time changing intravenous to oral therapy (60%, P-value < 0.001) and dosing schedule (30%, P-value = 0.003). …”
Publicado 2019
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64por Lv, Yuan, Luo, Bin‐yu, LaBadie, Robert R., Zhu, Hua, Feng, Yan, Ernst, Cynthia, Crownover, Penelope H., Liang, Yali, Zhao, Qinying“…Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUC(last), C(max), and AUC(inf) (ratio, 101.41%; 90%CI, 95.49%‐107.70%; ratio, 93.55%; 90%CI, 84.15%‐104.00%; and ratio, 101.03%; 90%CI, 94.80%‐107.66%; respectively) were wholly contained within the bioequivalence acceptance range of 80% to 125%, indicating bioequivalence criteria were met. …”
Publicado 2020
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65por Kapitza, Christoph, Nosek, Leszek, Schmider, Wolfgang, Teichert, Lenore, Mukherjee, Bhaswati, Nowotny, Irene“…In cohort 1, the extent of exposure (total and maximum concentration) was similar among the three treatments, with the 90% confidence intervals for pairwise treatment ratios meeting the predefined acceptance range (0.80 to 1.25). In cohort 2, statistically significant differences (P < .001) in early (0‐4 hours) and intermediate (4‐12 hours) exposure to SAR(Asp)‐Mix compared with SAR‐Asp were observed, all exceeding a 20% difference. …”
Publicado 2020
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66por Ngamdokmai, Ngamrayu, Ingkaninan, Kornkanok, Chaichamnong, Nattiya, Chootip, Krongkarn, Neungchamnong, Nitra, Waranuch, Neti“…The caffeine content showed no significant changes and passed the acceptance criteria of ≥80% at all tested temperatures. However, monoterpenes showed their stability for only 2 months at 50 °C. …”
Publicado 2021
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67por Sus, Jan, Huguet, Jade, Bosak, Jan, Setnik, Beatrice, Hauser, Tomas, Sicard, Eric“…BE for BISO/RAMI 10/5 mg and absence of a clinically relevant PK DDI between BISO and RAMI was demonstrated as the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for area under the concentration time curve (AUC) and maximum concentration (C(max)) remained within the acceptance range of 80.00 to 125.00%. However, BE for BISO/RAMI 10/10 mg was not demonstrated, as the lower bound of the 90% CI of C(max) for RAMI was outside the acceptance range of BE. …”
Publicado 2021
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68por Schurad, Bjoern, Koch, Cornelius, Schug, Barbara, Morte, Adelaida, Vaqué, Anna, De la Torre, Rafael, Iniesta, Marc“…Calculated point estimates and 90% CI for all primary parameters (AUC(96-264), Cmax(96-264) and Cmin(96-264)) were within the predefined acceptance interval of 80.00-125.00%. They were 113.64% (107.33-120.33), 105.14% (98.38- 112.38) and 107.82% (97.78-118.89) respectively. …”
Publicado 2022
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69por Zwart, Tom C., Metscher, Erik, van der Boog, Paul J. M., Swen, Jesse J., de Fijter, Johan W., Guchelaar, Henk‐Jan, de Vries, Aiko P. J., Moes, Dirk Jan A. R.“…Method agreement was evaluated using Passing–Bablok regression, Bland–Altman analysis and the percentages of values within 15–30% of the reference (P(15)–P(30)) with a P(20) acceptance threshold of 80%. RESULTS: For DBS samples, method agreement was excellent for tacrolimus trough concentrations (n = 25, P(15) = 92.0%) and AUCs (n = 25; P(20) = 95.8%) and adequate for creatinine‐based GFR trend monitoring (n = 25; P(20) = 80%). …”
Publicado 2022
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70por Matovu, Joseph K. B., Bogart, Laura M., Nakabugo, Jennifer, Kagaayi, Joseph, Serwadda, David, Wanyenze, Rhoda K., Ko, Albert I., Kurth, Ann E.“…The intervention was evaluated against the feasibility benchmark of 70% of peer-leaders distributing up to 70% of the kits that they received; and the acceptability benchmark of >80% of the respondents self-testing for HIV. …”
Publicado 2020
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71por Sun, Ming-Li, Liu, Hui-Juan, Luo, Xiang-Dong, Wang, Yu, Zhang, Wei, Liu, Chen, Wang, Xinghe“…The 90% CIs (96.12–105.44% for AUC from time zero to the time of the last measurable concentration [AUC(t)], 96.22–105.54% for AUC extrapolated from time zero to infinity [AUC(∞)], and 98.42–105.00% for C(max)) of T/R adjusted GMRs were within the bioequivalence acceptance range of 80.00–125.00%, indicating that they are bioequivalent. …”
Publicado 2022
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72por Rüggeberg, Sabrina, Wanglin, Antje, Demirel, Özlem, Hack, Rüdiger, Niederhaus, Birgit, Bidlingmaier, Bernd, Blumrich, Matthias, Usener, Dirk“…The recovery of quantitative in vitro in-cell Western (ICW) results compared to the in vivo test results was within the predefined acceptance limits of 80% to 125%. Thus, the in vitro ICW cell-based bioassay leads to results that are equivalent to the rabbit blood sugar test per USP <121>, and it is highly suitable for insulin activity quantification. …”
Publicado 2023
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73“…For each of the two liquid formulations, bioequivalence with the FD formulation was concluded if the 95% confidence intervals (CIs) for the estimated test/reference ratios of geometric means of AUC(0-t )and C(max )were within the standard pre-specified acceptance range (0.80-1.25). RESULTS: Fifteen men and 15 women enrolled (safety population, n = 30; PK population, n = 28). …”
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74por Algorta, Jaime, Andrade, Laura, Medina, Marta, Kirkov, Valentin, Arsova, Sacha, Li, Fumin, Chi, Jingduan“…Bioequivalence was accepted if the 90.20 % confidence interval (CI) for the ratio test/reference of the primary pharmacokinetic parameters lay within the acceptance range of 80–125 %. Safety assessment was a secondary endpoint. …”
Publicado 2016
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75“…The mean value of the BDG was higher than the accepted cutoff of 80 pg/mL in all three groups (Figure 1). …”
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76“…The Mi Band gained higher levels of acceptance (16/20, 80%) compared with the Microsoft Band (10/20, 50%). …”
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77por Scheidel, Bernhard, Maritz, Martina A., Gschwind, Yves J., Steigerwald, Kerstin, Guth, Volker, Kovacs, Peter, Rey, Helene“…Extent of bioavailability (AUC), maximum plasma concentrations (C(max)), and plasma concentrations at the end of the dosing interval (C(τ,ss,24h)) of OOD could be classified as comparable to OTD considering 90% confidence intervals (CIs) and acceptance limits of 80.00 – 125.00%. Bioavailability of OOD was not influenced by concomitant food intake. …”
Publicado 2017
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78por Ornstein, Moshe C., Wood, Laura S., Hobbs, Brian P., Allman, Kimberly D., Martin, Allison, Bevan, Michael, Gilligan, Timothy D., Garcia, Jorge A., Rini, Brian I.“…Intermittent nivolumab would be considered “feasible” if the acceptance rate was ≥80%. Forty patients provides > 95% power with 0.05 type I error, assuming a null acceptance rate of 50%. …”
Publicado 2019
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79por Singh, Devinder Kaur Ajit, Goh, Jing Wen, Shaharudin, Muhammad Iqbal, Shahar, Suzana“…RESULTS: The findings of our study showed that FallSA had a high acceptance level with 80% (12/15) of older persons agreeing on its suitability as a falls self-screening tool. …”
Publicado 2021
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80por Spelke, M. Bridget, Paul, Ravi, Blette, Bryan S., Meltzer‐Brody, Samantha, Schiller, Crystal E., Ncheka, J. M., Kasaro, Margaret P., Price, Joan T., Stringer, Jeffrey S. A., Stringer, Elizabeth M.“…A participant satisfaction survey assessed trial acceptability. RESULTS: 78/80 (98%) participants were retained at the final study visit. …”
Publicado 2022
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