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149 related items for PubMed ID: 26382609

  • 1. Decreased maternal and fetal cholesterol following maternal bococizumab (anti-PCSK9 monoclonal antibody) administration does not affect rat embryo-fetal development.
    Campion SN, Han B, Cappon GD, Lewis EM, Kraynov E, Liang H, Bowman CJ.
    Regul Toxicol Pharmacol; 2015 Nov; 73(2):562-70. PubMed ID: 26382609
    [Abstract] [Full Text] [Related]

  • 2. The effects of single- and multiple-dose administration of bococizumab (RN316/PF-04950615), a humanized IgG2Δa monoclonal antibody binding proprotein convertase subtilisin/kexin type 9, in hypercholesterolemic subjects treated with and without atorvastatin: Results from four phase I studies.
    Gumbiner B, Joh T, Liang H, Wan H, Levisetti M, Vana AM, Shelton DL, Forgues P, Billotte S, Pons J, Baum CM, Garzone PD.
    Cardiovasc Ther; 2018 Feb; 36(1):. PubMed ID: 29078037
    [Abstract] [Full Text] [Related]

  • 3. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia.
    Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H.
    Am J Cardiol; 2015 May 01; 115(9):1212-21. PubMed ID: 25784512
    [Abstract] [Full Text] [Related]

  • 4. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development.
    Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X.
    J Clin Pharmacol; 2017 Jul 01; 57(7):855-864. PubMed ID: 28181260
    [Abstract] [Full Text] [Related]

  • 5. Pharmacokinetics and pharmacodynamics of bococizumab, a monoclonal antibody to PCSK9, after single subcutaneous injection at three sites [NCT 02043301].
    Wang EQ, Plotka A, Salageanu J, Sattler C, Yunis C.
    Cardiovasc Ther; 2017 Oct 01; 35(5):. PubMed ID: 28636184
    [Abstract] [Full Text] [Related]

  • 6. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody.
    Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K.
    CPT Pharmacometrics Syst Pharmacol; 2023 Dec 01; 12(12):2013-2026. PubMed ID: 37994400
    [Abstract] [Full Text] [Related]

  • 7. Evaluation of the safety and pharmacokinetics of the multi-targeted receptor tyrosine kinase inhibitor sunitinib during embryo-fetal development in rats and rabbits.
    Patyna S, Haznedar J, Morris D, Freshwater K, Peng G, Sukbuntherng J, Chmielewski G, Matsumoto D.
    Birth Defects Res B Dev Reprod Toxicol; 2009 Jun 01; 86(3):204-13. PubMed ID: 19294680
    [Abstract] [Full Text] [Related]

  • 8. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects
.
    Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T.
    Int J Clin Pharmacol Ther; 2019 Dec 01; 57(12):575-589. PubMed ID: 31549625
    [Abstract] [Full Text] [Related]

  • 9. TGF-β1 monoclonal antibody: Assessment of embryo-fetal toxicity in rats and rabbits.
    Hilbish KG, Martin JA, Stauber AJ, Edwards TL, Breslin WJ.
    Birth Defects Res B Dev Reprod Toxicol; 2016 Aug 01; 107(4-5):174-184. PubMed ID: 27519584
    [Abstract] [Full Text] [Related]

  • 10. Plasma proprotein convertase subtilisin kexin type 9 levels are related to markers of cholesterol synthesis in familial combined hyperlipidemia.
    Brouwers MC, Konrad RJ, van Himbergen TM, Isaacs A, Otokozawa S, Troutt JS, Schaefer EJ, van Greevenbroek MM, Stalenhoef AF, de Graaf J.
    Nutr Metab Cardiovasc Dis; 2013 Nov 01; 23(11):1115-21. PubMed ID: 23333725
    [Abstract] [Full Text] [Related]

  • 11. Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies.
    Wang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D.
    BioDrugs; 2019 Oct 01; 33(5):571-579. PubMed ID: 31529318
    [Abstract] [Full Text] [Related]

  • 12. AMG145, a monoclonal antibody against proprotein convertase subtilisin kexin type 9, significantly reduces lipoprotein(a) in hypercholesterolemic patients receiving statin therapy: an analysis from the LDL-C Assessment with Proprotein Convertase Subtilisin Kexin Type 9 Monoclonal Antibody Inhibition Combined with Statin Therapy (LAPLACE)-Thrombolysis in Myocardial Infarction (TIMI) 57 trial.
    Desai NR, Kohli P, Giugliano RP, O'Donoghue ML, Somaratne R, Zhou J, Hoffman EB, Huang F, Rogers WJ, Wasserman SM, Scott R, Sabatine MS.
    Circulation; 2013 Aug 27; 128(9):962-9. PubMed ID: 23884353
    [Abstract] [Full Text] [Related]

  • 13. Developmental immunotoxicology assessment of rituximab in cynomolgus monkeys.
    Vaidyanathan A, McKeever K, Anand B, Eppler S, Weinbauer GF, Beyer JC.
    Toxicol Sci; 2011 Jan 27; 119(1):116-25. PubMed ID: 20937725
    [Abstract] [Full Text] [Related]

  • 14. Proprotein convertase substilisin/kexin type 9 antagonism reduces low-density lipoprotein cholesterol in statin-treated hypercholesterolemic nonhuman primates.
    Liang H, Chaparro-Riggers J, Strop P, Geng T, Sutton JE, Tsai D, Bai L, Abdiche Y, Dilley J, Yu J, Wu S, Chin SM, Lee NA, Rossi A, Lin JC, Rajpal A, Pons J, Shelton DL.
    J Pharmacol Exp Ther; 2012 Feb 27; 340(2):228-36. PubMed ID: 22019884
    [Abstract] [Full Text] [Related]

  • 15. Comparative Pharmacokinetics and Pharmacodynamics of Bococizumab Following a Single Subcutaneous Injection Using Drug Substance Manufactured at Two Sites or Administration via Two Different Devices.
    Wang EQ, Plotka A, Salageanu J, Baltrukonis D, Mridha K, Frederich R, Sullivan BE.
    Clin Pharmacol Drug Dev; 2019 Jan 27; 8(1):40-48. PubMed ID: 29688615
    [Abstract] [Full Text] [Related]

  • 16. Embryo-fetal distribution of a biopharmaceutical IgG2 during rat organogenesis.
    Bowman CJ, King LE, Stedman DB.
    Reprod Toxicol; 2012 Aug 27; 34(1):66-72. PubMed ID: 22543284
    [Abstract] [Full Text] [Related]

  • 17. Developmental Toxicity and Fertility Assessment in Rabbits with Tabalumab: A Human IgG4 Monoclonal Antibody.
    Breslin WJ, Hilbish KG, Martin JA, Halstead CA, Edwards TL.
    Birth Defects Res B Dev Reprod Toxicol; 2015 Jun 27; 104(3):117-28. PubMed ID: 26195315
    [Abstract] [Full Text] [Related]

  • 18. AMG 145, a monoclonal antibody against PCSK9, facilitates achievement of national cholesterol education program-adult treatment panel III low-density lipoprotein cholesterol goals among high-risk patients: an analysis from the LAPLACE-TIMI 57 trial (LDL-C assessment with PCSK9 monoclonal antibody inhibition combined with statin thErapy-thrombolysis in myocardial infarction 57).
    Desai NR, Giugliano RP, Zhou J, Kohli P, Somaratne R, Hoffman E, Liu T, Scott R, Wasserman SM, Sabatine MS.
    J Am Coll Cardiol; 2014 Feb 11; 63(5):430-3. PubMed ID: 24161333
    [Abstract] [Full Text] [Related]

  • 19. Proprotein convertase subtilisin/kexin type 9 inhibition: a new therapeutic mechanism for reducing cardiovascular disease risk.
    Bergeron N, Phan BA, Ding Y, Fong A, Krauss RM.
    Circulation; 2015 Oct 27; 132(17):1648-66. PubMed ID: 26503748
    [Abstract] [Full Text] [Related]

  • 20. Regulatory Experience Assessing the Carcinogenic Potential of a Monoclonal Antibody Inhibiting PCSK9, Bococizumab, Including a 2-Year Carcinogenicity Study in Rats.
    Buetow BS, Cappon GD, Aschenbrenner LM, Updyke L, Torti VR, Evans M, Dalton SR, Bailey S, Bowman CJ.
    Int J Toxicol; 2022 Oct 27; 41(5):389-401. PubMed ID: 35672934
    [Abstract] [Full Text] [Related]

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