Population Pharmacokinetic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using a Michaelis–Menten Approximation of a Target-Mediated Drug Disposition Model—Support for a Biologics License Application Submission: Part I

Biologics License Application ◽

License Application ◽

Disposition Model ◽

Model Support ◽

Hypercholesterolemic Subjects

Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic–pharmacodynamic modeling of biologics

Expert Opinion on Drug Metabolism & Toxicology ◽

10.1517/17425250902992901 ◽

2009 ◽

Vol 5 (7) ◽

pp. 803-812 ◽

Cited By ~ 73

Author(s):

Leonid Gibiansky ◽

Ekaterina Gibiansky

Keyword(s):

Drug Disposition ◽

Pharmacodynamic Modeling ◽

Model Parameters ◽

Disposition Model

Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II

Clinical Pharmacokinetics ◽

10.1007/s40262-018-0670-5 ◽

2018 ◽

Vol 58 (1) ◽

pp. 115-130 ◽

Cited By ~ 3

Author(s):

Xavier Nicolas ◽

Nassim Djebli ◽

Clémence Rauch ◽

Aurélie Brunet ◽

Fabrice Hurbin ◽

...

Keyword(s):

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Low Density Lipoprotein Cholesterol ◽

Indirect Response Model ◽

Indirect Response ◽

Biologics License Application ◽

Pharmacodynamic Analysis ◽

License Application ◽

Hypercholesterolemic Subjects

Population Pharmacokinetic Analysis of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) in Adult and Pediatric Patients with Severe Hemophilia B

10.1055/s-0039-1680223 ◽

2019 ◽

Author(s):

Y. Zhang ◽

W. McKeand ◽

T. Yuraszeck ◽

W. Seifert ◽

A. Feussner ◽

...

Keyword(s):

Fusion Protein ◽

Pediatric Patients ◽

Coagulation Factor ◽

Factor Ix ◽

Hemophilia B ◽

Severe Hemophilia ◽

Coagulation Factor Ix

Population pharmacokinetic analysis of the microemulsion formulation of cyclosporin A (NeoralR) in renal transplant patients

Therapy ◽

10.1586/14750708.3.2.259 ◽

2006 ◽

Vol 3 (2) ◽

pp. 259-264

Author(s):

Dawei Xuan ◽

Charles H Nightingale ◽

David Hull ◽

David P Nicolau

Keyword(s):

Renal Transplant ◽

Cyclosporin A ◽

Microemulsion Formulation ◽

Transplant Patients ◽

Renal Transplant Patients

Faculty of 1000 evaluation for Phase I dose-escalation study and population pharmacokinetic analysis of fixed dose rate gemcitabine plus carboplatin as second-line therapy in patients with ovarian cancer.

F1000 - Post-publication peer review of the biomedical literature ◽

10.3410/f.718016158.793478648 ◽

2013 ◽

Author(s):

Steve Plaxe ◽

Kristy Ward

Keyword(s):

Ovarian Cancer ◽

Fixed Dose ◽

Second Line ◽

Second Line Therapy ◽

Dose Escalation Study ◽

Line Therapy ◽

Fixed Dose Rate

Faculty Opinions recommendation of Population pharmacokinetic analysis of propofol in underweight patients under general anaesthesia.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.733832153.793550421 ◽

2018 ◽

Author(s):

Harald Ihmsen

Keyword(s):

General Anaesthesia ◽

Underweight Patients

Population Pharmacokinetic Analysis of N‐acetylcysteine in Pediatric Patients with Inherited Metabolic Disorders Undergoing Hematopoietic Stem Cell Transplant

The Journal of Clinical Pharmacology ◽

10.1002/jcph.1943 ◽

2021 ◽

Author(s):

Siddhee A Sahasrabudhe ◽

Reena V Kartha ◽

Michelle Ng ◽

Lisa M Basso ◽

Usha Mishra ◽

...

Keyword(s):

Metabolic Disorders ◽

Hematopoietic Stem Cell Transplant ◽

Pediatric Patients ◽

Stem Cell Transplant ◽

Cell Transplant ◽

Hematopoietic Stem ◽

Inherited Metabolic Disorders

A Target‐Mediated Drug Disposition Population Pharmacokinetic Model of GC1118, a Novel Anti‐EGFR Antibody, in Patients with Solid Tumors

Clinical and Translational Science ◽

10.1111/cts.12963 ◽

2020 ◽

Author(s):

Tae Kyu Chung ◽

Hyun A Lee ◽

Sang‐In Park ◽

Do‐Youn Oh ◽

Keun‐Wook Lee ◽

...

Keyword(s):

Solid Tumors ◽

Population Pharmacokinetic Model ◽

Pharmacokinetic Model ◽

Drug Disposition ◽

Egfr Antibody

Population Pharmacokinetic Analysis of Panitumumab in Patients With Advanced Solid Tumors

The Journal of Clinical Pharmacology ◽

10.1177/0091270009344989 ◽

2009 ◽

Vol 49 (10) ◽

pp. 1142-1156 ◽

Cited By ~ 65

Author(s):

Peiming Ma ◽

Bing-Bing Yang ◽

Yow-Ming Wang ◽

Mark Peterson ◽

Adimoolam Narayanan ◽

...

Keyword(s):

Solid Tumors ◽

Advanced Solid Tumors

Target-mediated drug disposition model for drugs with two binding sites that bind to a target with one binding site

Journal of Pharmacokinetics and Pharmacodynamics ◽

10.1007/s10928-017-9533-1 ◽

2017 ◽

Vol 44 (5) ◽

pp. 463-475 ◽

Cited By ~ 5

Author(s):

Leonid Gibiansky ◽

Ekaterina Gibiansky

Keyword(s):

Binding Site ◽

Binding Sites ◽

Drug Disposition ◽

Disposition Model