Evaluation of Evolocumab (AMG 145), a Fully Human Anti-PCSK9 IgG2 Monoclonal Antibody, in Subjects With Hepatic Impairment-Reference-Cited by-同舟云学术

Evaluation of Evolocumab (AMG 145), a Fully Human Anti-PCSK9 IgG2 Monoclonal Antibody, in Subjects With Hepatic Impairment

Published:2016-10-26 Issue:4 Volume:57 Page:513-523
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Gibbs John P.¹²,Slatter J. Greg¹³,Egbuna Ogo¹,Geller Michelle⁴,Hamilton Lisa⁵,Dias Clapton S.¹⁶,Xu Ren Y.¹⁷,Johnson Jessica¹,Wasserman Scott M.⁸,Emery Maurice G.¹

Affiliation:

1. Medical Sciences; Amgen, Inc.; Thousand Oaks CA, USA

2. AbbVie; North Chicago IL, USA

3. Acerta Pharma; Bellevue WA, USA

4. Global Safety; Amgen, Inc.; Thousand Oaks CA, USA

5. Biostatistics-Internationals; Amgen, Inc.; Uxbridge UK

6. BioMarin Pharmaceutical Inc.; San Rafael CA, USA

7. Gilead Science Inc.; Foster City CA, USA

8. Global Development; Amgen, Inc.; Thousand Oaks CA, USA

Funder

Amgen

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference32 articles.

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2. Are hepatic impairment studies necessary for therapeutic proteins?;Yang;Clin Ther,2013

3. Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies;Dostalek;Clin Pharmacokinet,2013

4. Emerging low-density lipoprotein therapies: targeting PCSK9 for low-density lipoprotein reduction;Davidson;J Clin Lipidol,2013

5. 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;Circulation,2013

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