PubMed:26984210 JSONTXT

{"project":"wangzhuo19_800_2","denotations":[{"id":"T1","span":{"begin":43,"end":54},"obj":"CI"},{"id":"T2","span":{"begin":178,"end":189},"obj":"CI"},{"id":"T3","span":{"begin":502,"end":513},"obj":"CI"},{"id":"T4","span":{"begin":1137,"end":1148},"obj":"CI"},{"id":"T5","span":{"begin":1357,"end":1368},"obj":"CI"},{"id":"T6","span":{"begin":1611,"end":1622},"obj":"CI"},{"id":"T7","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T8","span":{"begin":85,"end":96},"obj":"CI"},{"id":"T9","span":{"begin":203,"end":214},"obj":"CI"},{"id":"T10","span":{"begin":230,"end":241},"obj":"CI"},{"id":"T11","span":{"begin":275,"end":286},"obj":"CI"},{"id":"T12","span":{"begin":300,"end":311},"obj":"CI"},{"id":"T13","span":{"begin":324,"end":335},"obj":"CI"},{"id":"T14","span":{"begin":342,"end":353},"obj":"CI"},{"id":"T15","span":{"begin":515,"end":526},"obj":"CI"},{"id":"T16","span":{"begin":534,"end":545},"obj":"CI"},{"id":"T17","span":{"begin":1152,"end":1163},"obj":"CI"},{"id":"T18","span":{"begin":1170,"end":1181},"obj":"CI"},{"id":"T19","span":{"begin":1193,"end":1204},"obj":"CI"},{"id":"T20","span":{"begin":1211,"end":1222},"obj":"CI"},{"id":"T21","span":{"begin":1370,"end":1381},"obj":"CI"},{"id":"T22","span":{"begin":1390,"end":1401},"obj":"CI"},{"id":"T23","span":{"begin":1624,"end":1635},"obj":"CI"},{"id":"T24","span":{"begin":1644,"end":1655},"obj":"CI"},{"id":"T25","span":{"begin":1780,"end":1791},"obj":"CI"},{"id":"T26","span":{"begin":1799,"end":1810},"obj":"CI"},{"id":"T27","span":{"begin":1822,"end":1833},"obj":"CI"},{"id":"T28","span":{"begin":1840,"end":1851},"obj":"CI"}],"text":"A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.\nPURPOSE: This study compared the pharmacokinetics of PF-06439535, a potential bevacizumab biosimilar, to bevacizumab sourced from the European Union (bevacizumab-EU) and USA (bevacizumab-US), and of bevacizumab-EU to bevacizumab-US.\nMETHODS: In this double-blind study, 102 healthy males, aged 21-55 years, were randomized 1:1:1 to receive a single 5 mg/kg intravenous dose of PF-06439535, bevacizumab-EU, or bevacizumab-US. Pharmacokinetic assessments were conducted for 71 days, with additional safety and immunogenicity assessments until day 100. Pharmacokinetic similarity was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the maximum serum concentration (C max), area under the serum concentration-time curve from zero to infinity (AUC0-∞), and from zero to time of last quantifiable concentration (AUC0-t ) were within the 80.00-125.00 % bioequivalence acceptance window.\nRESULTS: The three study drugs exhibited similar pharmacokinetic properties. For the comparisons of PF-06439535 to bevacizumab-EU or bevacizumab-US, and of bevacizumab-EU to bevacizumab-US, the 90 % CIs for the ratios of C max, AUC0-t , and AUC0-∞ were all within 80.00-125.00 %. Two, one, and two subjects treated with PF-06439535, bevacizumab-EU, and bevacizumab-US, respectively, tested positive for antidrug antibodies, none of whom tested positive for neutralizing antibodies. Treatment-related adverse events were reported in 15.2, 25.7, and 18.2 % of subjects in the PF-06439535, bevacizumab-EU, and bevacizumab-US treatment arms, respectively.\nCONCLUSIONS: This study demonstrated the pharmacokinetic similarity of PF-06439535 to both bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. The safety profile (including immunogenicity) was similar in the three treatment groups, with no significant safety findings reported."}

{"project":"yangbin123xm_800_3","denotations":[{"id":"T1","span":{"begin":85,"end":96},"obj":"CI"},{"id":"T2","span":{"begin":203,"end":214},"obj":"CI"},{"id":"T22","span":{"begin":43,"end":54},"obj":"CI"},{"id":"T23","span":{"begin":178,"end":189},"obj":"CI"},{"id":"T24","span":{"begin":502,"end":513},"obj":"CI"},{"id":"T25","span":{"begin":1137,"end":1148},"obj":"CI"},{"id":"T26","span":{"begin":1357,"end":1368},"obj":"CI"},{"id":"T27","span":{"begin":1611,"end":1622},"obj":"CI"},{"id":"T28","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T3","span":{"begin":230,"end":241},"obj":"CI"},{"id":"T29","span":{"begin":324,"end":338},"obj":"CI"},{"id":"T30","span":{"begin":275,"end":289},"obj":"CI"},{"id":"T31","span":{"begin":515,"end":529},"obj":"CI"},{"id":"T32","span":{"begin":1152,"end":1166},"obj":"CI"},{"id":"T33","span":{"begin":1193,"end":1207},"obj":"CI"},{"id":"T34","span":{"begin":1370,"end":1384},"obj":"CI"},{"id":"T35","span":{"begin":1624,"end":1638},"obj":"CI"},{"id":"T36","span":{"begin":1780,"end":1794},"obj":"CI"},{"id":"T37","span":{"begin":1822,"end":1836},"obj":"CI"},{"id":"T38","span":{"begin":342,"end":356},"obj":"CI"},{"id":"T39","span":{"begin":300,"end":314},"obj":"CI"},{"id":"T40","span":{"begin":534,"end":548},"obj":"CI"},{"id":"T41","span":{"begin":1170,"end":1184},"obj":"CI"},{"id":"T42","span":{"begin":1211,"end":1225},"obj":"CI"},{"id":"T43","span":{"begin":1390,"end":1404},"obj":"CI"},{"id":"T44","span":{"begin":1644,"end":1658},"obj":"CI"},{"id":"T45","span":{"begin":1799,"end":1813},"obj":"CI"},{"id":"T46","span":{"begin":1840,"end":1854},"obj":"CI"}],"text":"A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.\nPURPOSE: This study compared the pharmacokinetics of PF-06439535, a potential bevacizumab biosimilar, to bevacizumab sourced from the European Union (bevacizumab-EU) and USA (bevacizumab-US), and of bevacizumab-EU to bevacizumab-US.\nMETHODS: In this double-blind study, 102 healthy males, aged 21-55 years, were randomized 1:1:1 to receive a single 5 mg/kg intravenous dose of PF-06439535, bevacizumab-EU, or bevacizumab-US. Pharmacokinetic assessments were conducted for 71 days, with additional safety and immunogenicity assessments until day 100. Pharmacokinetic similarity was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the maximum serum concentration (C max), area under the serum concentration-time curve from zero to infinity (AUC0-∞), and from zero to time of last quantifiable concentration (AUC0-t ) were within the 80.00-125.00 % bioequivalence acceptance window.\nRESULTS: The three study drugs exhibited similar pharmacokinetic properties. For the comparisons of PF-06439535 to bevacizumab-EU or bevacizumab-US, and of bevacizumab-EU to bevacizumab-US, the 90 % CIs for the ratios of C max, AUC0-t , and AUC0-∞ were all within 80.00-125.00 %. Two, one, and two subjects treated with PF-06439535, bevacizumab-EU, and bevacizumab-US, respectively, tested positive for antidrug antibodies, none of whom tested positive for neutralizing antibodies. Treatment-related adverse events were reported in 15.2, 25.7, and 18.2 % of subjects in the PF-06439535, bevacizumab-EU, and bevacizumab-US treatment arms, respectively.\nCONCLUSIONS: This study demonstrated the pharmacokinetic similarity of PF-06439535 to both bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. The safety profile (including immunogenicity) was similar in the three treatment groups, with no significant safety findings reported."}

{"project":"chenxin_473849_800_3","denotations":[{"id":"T1","span":{"begin":43,"end":54},"obj":"CI"},{"id":"T10","span":{"begin":515,"end":529},"obj":"CI"},{"id":"T11","span":{"begin":1152,"end":1166},"obj":"CI"},{"id":"T12","span":{"begin":1193,"end":1207},"obj":"CI"},{"id":"T13","span":{"begin":1370,"end":1384},"obj":"CI"},{"id":"T14","span":{"begin":1624,"end":1638},"obj":"CI"},{"id":"T15","span":{"begin":1780,"end":1794},"obj":"CI"},{"id":"T16","span":{"begin":1822,"end":1836},"obj":"CI"},{"id":"T17","span":{"begin":300,"end":314},"obj":"CI"},{"id":"T18","span":{"begin":342,"end":356},"obj":"CI"},{"id":"T19","span":{"begin":534,"end":548},"obj":"CI"},{"id":"T2","span":{"begin":178,"end":189},"obj":"CI"},{"id":"T20","span":{"begin":1170,"end":1184},"obj":"CI"},{"id":"T21","span":{"begin":1211,"end":1225},"obj":"CI"},{"id":"T22","span":{"begin":1390,"end":1404},"obj":"CI"},{"id":"T23","span":{"begin":1644,"end":1658},"obj":"CI"},{"id":"T24","span":{"begin":1799,"end":1813},"obj":"CI"},{"id":"T25","span":{"begin":1840,"end":1854},"obj":"CI"},{"id":"T26","span":{"begin":203,"end":214},"obj":"CI"},{"id":"T27","span":{"begin":85,"end":96},"obj":"CI"},{"id":"T3","span":{"begin":502,"end":513},"obj":"CI"},{"id":"T4","span":{"begin":1137,"end":1148},"obj":"CI"},{"id":"T5","span":{"begin":1357,"end":1368},"obj":"CI"},{"id":"T6","span":{"begin":1611,"end":1622},"obj":"CI"},{"id":"T7","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T8","span":{"begin":275,"end":289},"obj":"CI"},{"id":"T9","span":{"begin":324,"end":338},"obj":"CI"},{"id":"T28","span":{"begin":230,"end":241},"obj":"CI"}],"text":"A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.\nPURPOSE: This study compared the pharmacokinetics of PF-06439535, a potential bevacizumab biosimilar, to bevacizumab sourced from the European Union (bevacizumab-EU) and USA (bevacizumab-US), and of bevacizumab-EU to bevacizumab-US.\nMETHODS: In this double-blind study, 102 healthy males, aged 21-55 years, were randomized 1:1:1 to receive a single 5 mg/kg intravenous dose of PF-06439535, bevacizumab-EU, or bevacizumab-US. Pharmacokinetic assessments were conducted for 71 days, with additional safety and immunogenicity assessments until day 100. Pharmacokinetic similarity was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the maximum serum concentration (C max), area under the serum concentration-time curve from zero to infinity (AUC0-∞), and from zero to time of last quantifiable concentration (AUC0-t ) were within the 80.00-125.00 % bioequivalence acceptance window.\nRESULTS: The three study drugs exhibited similar pharmacokinetic properties. For the comparisons of PF-06439535 to bevacizumab-EU or bevacizumab-US, and of bevacizumab-EU to bevacizumab-US, the 90 % CIs for the ratios of C max, AUC0-t , and AUC0-∞ were all within 80.00-125.00 %. Two, one, and two subjects treated with PF-06439535, bevacizumab-EU, and bevacizumab-US, respectively, tested positive for antidrug antibodies, none of whom tested positive for neutralizing antibodies. Treatment-related adverse events were reported in 15.2, 25.7, and 18.2 % of subjects in the PF-06439535, bevacizumab-EU, and bevacizumab-US treatment arms, respectively.\nCONCLUSIONS: This study demonstrated the pharmacokinetic similarity of PF-06439535 to both bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. The safety profile (including immunogenicity) was similar in the three treatment groups, with no significant safety findings reported."}