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81por Schnaars, Yvonne, Gaikwad, Sumedh, Gottwald-Hostalek, Ulrike, Uhl, Wolfgang, Ribot, Olga, Varanasi, Kanthikiran V. S., Rodríguez, Laura, Torrejón, Javier, Gómez, Luis“…Test (T) and reference (R) formulations proved bioequivalent if 90% confidence interval (CI) of geometric least-squares mean ratio for AUC(0–t) and C(max) were within BE acceptance range of 80.00–125.00%. Safety evaluations included vital signs, clinical laboratory tests, and adverse events (AEs). …”
Publicado 2022
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82por Shaw, Andrew, Lawrence, Tracey E., Yan, Tieliang, Liu, Mark, Summers, Nancy, Daggumati, Venkatesh, Austria, Sandy Tarr, Rondon, Juan Carlos, Hackley, Sarah, Vignesh, Shivani Ohri, Hassan, Tarek A.“…These ratios were within the bioequivalence acceptance range of 80% to 125%, indicating that the bioequivalence criteria were met. …”
Publicado 2023
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83por Subedi, Narayan, Rawstorn, Jonathan C, Gao, Lan, Koorts, Harriet, Maddison, Ralph“…A total of 10 studies of 2250 participants evaluated implementation outcomes, including acceptability (8/10, 80%), appropriateness (9/10, 90%), adoption (6/10, 60%), feasibility (6/10, 60%), fidelity (7/10, 70%), and implementation cost (4/10, 40%), predominantly from the participant perspective. …”
Publicado 2020
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84por Daher, André, Pinto, Douglas Pereira, da Fonseca, Laís Bastos, Pereira, Heliana Martins, da Silva, Diego Medeiros Dias, da Silva, Letícia de Sá Fernandes Vallim, Esteves, Alessandra Lanzillotta, Soares Medeiros, Juliana J., Mendonça, Jorge Souza“…As Cmax and AUC0-t 90% CI were within the acceptance interval of 80–125% in all cases, the formulations tested were bioequivalent. …”
Publicado 2022
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85por Lefèvre, Gilbert, Bhad, Prafulla, Jain, Jay Prakash, Kalluri, Sampath, Cheng, Yi, Dave, Hardik, Stein, Daniel S“…GMR for C(max) and AUC(last) for artemether and lumefantrine for all primary comparisons were within the bioequivalence acceptance criteria (0.80-1.25). In addition, secondary PK parameters also met bioequivalence criterion. …”
Publicado 2013
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86“…Point estimate and 90% CIs were within the acceptance range [0.80;1.25]; bioequivalence criterion for AUC was met. …”
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