Pharmacokinetic and pharmacodynamic modelling of continuous erythropoiesis receptor activator in children: A comprehensive analysis and real‐world data validation
Sign Up to like & getrecommendations! Published in 2025 at "British Journal of Clinical Pharmacology"
DOI: 10.1002/bcp.70165
Abstract: To further assess the pharmacokinetic/pharmacodynamic characteristics of methoxy polyethylene glycol‐epoetin β (continuous erythropoiesis receptor activator; C.E.R.A.) in children with chronic kidney disease (CKD) aged 3 months to 18 years undergoing different dialysis modalities and receiving intravenous/subcutaneous doses,… read more here.
Keywords: erythropoiesis receptor; continuous erythropoiesis; receptor activator; activator children ... See more keywords
Population pharmacokinetic/pharmacodynamic model of LY06006 in Chinese healthy subjects and postmenopausal osteoporotic women.
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DOI: 10.1002/bcp.70275
Abstract: AIMS LY06006, a biosimilar of denosumab, is a recombinant fully human monoclonal antibody targeting the receptor activator of nuclear factor κB ligand. LY06006 has completed Phase I and Phase III clinical studies. The objective of… read more here.
Keywords: model ly06006; chinese healthy; model; healthy male ... See more keywords
Extrapolation of Midazolam Disposition in Neonates Using Physiological‐Based Pharmacokinetic/Pharmacodynamic Modeling
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DOI: 10.1002/cpdd.1531
Abstract: There is a shortage of data in clinical studies of neonatal populations, which often utilize extrapolation strategies and model simulation techniques to support drug development and clinical applications. This study established an adult physiological‐based pharmacokinetic/pharmacodynamic… read more here.
Keywords: neonates using; based pharmacokinetic; physiological based; extrapolation ... See more keywords
Population Pharmacokinetic/Pharmacodynamic and Exposure‐Response Modeling Analyses of Sotatercept in Healthy Participants and Patients with Pulmonary Arterial Hypertension
Sign Up to like & getrecommendations! Published in 2024 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.3524
Abstract: Sotatercept is a breakthrough, first‐in‐class biologic, recently approved by the Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). Exposure‐response (E‐R) analyses and pharmacokinetic/pharmacodynamic (PK/PD) modeling were performed for sotatercept after… read more here.
Keywords: arterial hypertension; pharmacokinetic pharmacodynamic; exposure response; pulmonary arterial ... See more keywords
Insights Into Aldosterone Regulation Through Pharmacokinetic-Pharmacodynamic Modeling of an Aldosterone Synthase Inhibitor.
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DOI: 10.1002/cpt.70114
Abstract: Aldosterone is a mineralocorticoid hormone essential for regulating renal function and blood pressure. Despite its clinical relevance, key aspects of aldosterone pharmacokinetics (PK) and physiological dynamics remain incompletely understood. In serial stages, we developed a… read more here.
Keywords: aldosterone; aldosterone synthase; pharmacokinetic pharmacodynamic; production ... See more keywords
Prolonged Pharmacokinetic and Pharmacodynamic Actions of a Pegylated Parathyroid Hormone (1‐34) Peptide Fragment
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DOI: 10.1002/jbmr.2917
Abstract: Polyethylene glycol (PEG) addition can prolong the pharmacokinetic and pharmacodynamic actions of a bioactive peptide in vivo, in part by impeding rates of glomerular filtration. For parathyroid hormone (PTH) peptides, pegylation could help in exploring… read more here.
Keywords: pth; pharmacodynamic actions; peptide; prolonged pharmacokinetic ... See more keywords
Dose Optimization of BIIB107, an Anti-Alpha-4 Integrin Monoclonal Antibody, Through Population Pharmacokinetic and Pharmacodynamic Modeling.
Sign Up to like & getrecommendations! Published in 2025 at "Journal of clinical pharmacology"
DOI: 10.1002/jcph.70109
Abstract: BIIB107 is a recombinant, humanized monoclonal antibody targeting α4 integrin receptors, exhibiting a high binding affinity and strong receptor engagement potential in preclinical models, designed to prevent lymphocyte trafficking in multiple sclerosis (MS). This study… read more here.
Keywords: monoclonal antibody; biib107; model; dose optimization ... See more keywords
Pharmacokinetic and pharmacodynamic considerations of antibiotics and antifungals in liver transplantation recipients
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DOI: 10.1002/lt.26517
Abstract: The liver plays a major role in drug metabolism. Liver transplantation impacts the intrinsic metabolic capability and extrahepatic mechanisms of drug disposition and elimination. Different levels of inflammation and oxidative stress during transplantation, the process… read more here.
Keywords: pharmacokinetic pharmacodynamic; transplantation; considerations antibiotics; transplantation recipients ... See more keywords
ADME: Assessing Pharmacokinetic-Pharmacodynamic Parameters of Oligonucleotides.
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DOI: 10.1007/978-1-4939-9670-4_19
Abstract: We describe tactics to assess pharmacokinetic (PK) and pharmacodynamic (PD) parameters of oligonucleotides. The chapter includes recommendations on the design of single-dose preclinical PK studies, preclinical PKPD studies, and toxicological studies, and on best practice… read more here.
Keywords: parameters oligonucleotides; pharmacodynamic parameters; assessing pharmacokinetic; biology ... See more keywords
The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study
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DOI: 10.1007/s00198-018-4741-0
Abstract: SummaryTo demonstrate the clinical comparability between RGB-10 (a biosimilar teriparatide) and the originator, a comparative pharmacokinetic trial was conducted. The study was successful in establishing bioequivalence. Marketing authorisation for RGB-10 (Terrosa®) was granted by the… read more here.
Keywords: comparative pharmacokinetic; study; biosimilar approved; pharmacokinetic pharmacodynamic ... See more keywords
Evaluation of pharmacokinetic and pharmacodynamic parameters following single dose of sitagliptin in healthy Indian males
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DOI: 10.1007/s00228-018-2433-5
Abstract: PurposeSitagliptin, a dipeptidyl peptidase (DPP)-IV inhibitor approved for the treatment of type 2 diabetes, is reported to be more efficacious in Indian patients than non-Indian patient population. The objective of the study was to evaluate… read more here.
Keywords: healthy indian; dose sitagliptin; pharmacodynamic parameters; pharmacokinetic pharmacodynamic ... See more keywords