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PMC10600068
core_pubmed_pmc
Pharmacokinetics and Safety of Ainuovirine/Lamivudine/Tenofovir Combination Tablets in Young and Elderly Patients with Human Immunodeficiency Virus-1 Infection
Pharmacokinetics and Safety of Ainuovirine/Lamivudine/Tenofovir Combination Tablets in Young and Elderly Patients with Human Immunodeficiency Virus-1 Infection Abstract Abstract Introduction Ainuovirine/lamivudine/tenofovir is a novel antiretroviral therapy regimen used to treat human immunodeficiency virus-1 (HIV-1) i...
PMC11224900
core_pubmed_pmc
Pharmacokinetics and bioequivalence study of candesartan cilexetil tablet in Chinese volunteers under fasting condition: an open-label, randomized-sequence, 2-period crossover study
Pharmacokinetics and bioequivalence study of candesartan cilexetil tablet in Chinese volunteers under fasting condition: an open-label, randomized-sequence, 2-period crossover study Abstract Abstract Candesartan is an antihypertensive agent that acts on an angiotensin II receptor. Candesartan cilexetil is a prodrug tha...
PMC10932186
core_pubmed_pmc
Stereoselective Analysis of the Antiseizure Activity of Fenfluramine and Norfenfluramine in Mice: Is l -Norfenfluramine a Better Follow-Up Compound to Racemic-Fenfluramine?
Stereoselective Analysis of the Antiseizure Activity of Fenfluramine and Norfenfluramine in Mice: Is l -Norfenfluramine a Better Follow-Up Compound to Racemic-Fenfluramine? Abstract Abstract The aim of this study was to investigate the comparative antiseizure activity of the l -enantiomers of d , l -fenfluramine and d ...
PMC7984326
core_pubmed_pmc
Pharmacokinetics and Pharmacodynamics of Lysergic Acid Diethylamide Microdoses in Healthy Participants
Pharmacokinetics and Pharmacodynamics of Lysergic Acid Diethylamide Microdoses in Healthy Participants Abstract “Microdoses” of lysergic acid diethylamide (LSD) are used recreationally to enhance mood and cognition. Increasing interest has also been seen in developing LSD into a medication. Therefore, we performed a ph...
PMC4118603
core_pubmed_pmc
Deciphering next-generation pharmacogenomics: an information technology perspective
Deciphering next-generation pharmacogenomics: an information technology perspective Abstract In the post-genomic era, the rapid evolution of high-throughput genotyping technologies and the increased pace of production of genetic research data are continually prompting the development of appropriate informatics tools, s...
PMC9304251
core_pubmed_pmc
Metformin serum concentrations during pregnancy and post partum – A clinical study in patients with polycystic ovary syndrome
Metformin serum concentrations during pregnancy and post partum – A clinical study in patients with polycystic ovary syndrome Abstract Abstract Background and objectives Metformin is used to treat gestational diabetes. It is also used to treat women with polycystic ovary syndrome and has been shown to prevent late misc...
PMC12335535
core_pubmed_pmc
Pharmacokinetic, biodistribution, safety and efficacy studies of borophenylalanine (BPA) in BNCT in hepatocellular carcinoma cells and tumor-bearing mouse model
Pharmacokinetic, biodistribution, safety and efficacy studies of borophenylalanine (BPA) in BNCT in hepatocellular carcinoma cells and tumor-bearing mouse model Abstract Boron neutron capture therapy (BNCT), using boronophenylalanine (BPA) as the main boron carrier, is a dual-targeted particle radiotherapy at the cellu...
PMC10499403
core_pubmed_pmc
Prevalence and utility of pharmacokinetic data in preclinical studies of mRNA cancer vaccines
Prevalence and utility of pharmacokinetic data in preclinical studies of mRNA cancer vaccines Abstract Abstract In this brief report, we provide insights into current practices in preclinical messenger RNA (mRNA) cancer vaccine characterization. To enable a more automated and thorough survey of mRNA cancer vaccine data...
PMC9661781
core_pubmed_pmc
Human targeted phenobarbital presents a poor substrate of gut microbiome deciphering new drug targets beyond pharmacokinetic curbs
Human targeted phenobarbital presents a poor substrate of gut microbiome deciphering new drug targets beyond pharmacokinetic curbs Abstract Background The gut microbiome, a new organ of the body, can potentially alter the pharmacokinetics of orally administered drugs through microbial enzymes. However, absorption of or...
PMC11555159
core_pubmed_pmc
Association of anti‐calcitonin gene‐related peptide with other monoclonal antibodies for different diseases: A multicenter, prospective, cohort study
Association of anti‐calcitonin gene‐related peptide with other monoclonal antibodies for different diseases: A multicenter, prospective, cohort study Abstract Abstract Background and purpose Although there is extensive evidence about the safety of monoclonal antibodies against calcitonin gene‐related peptide (anti‐CGRP...
PMC7496665
core_pubmed_pmc
Exploring the Relationship Between Morphine Concentration and Oversedation in Children After Cardiac Surgery
Exploring the Relationship Between Morphine Concentration and Oversedation in Children After Cardiac Surgery Abstract Abstract Titrating analgesic and sedative drugs in pediatric intensive care remains a challenge for caregivers due to the lack of pharmacodynamic knowledge in this population. The aim of the current stu...
PMC9338003
core_pubmed_pmc
Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet
Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet Abstract Abstract Background and Objective Venetoclax is an approved BCL-2 inhibitor, currently under evaluation in different hematological malignancies in adult and pediat...
PMC7407857
core_pubmed_pmc
Current Approaches and Techniques in Physiologically Based Pharmacokinetic (PBPK) Modelling of Nanomaterials
Current Approaches and Techniques in Physiologically Based Pharmacokinetic (PBPK) Modelling of Nanomaterials Abstract Abstract There have been efforts to develop physiologically based pharmacokinetic (PBPK) models for nanomaterials (NMs). Since NMs have quite different kinetic behaviors, the applicability of the approa...
PMC3652196
core_pubmed_pmc
Pharmacometrics of 3-Methoxypterostilbene: A Component of Traditional Chinese Medicinal Plants
Pharmacometrics of 3-Methoxypterostilbene: A Component of Traditional Chinese Medicinal Plants Abstract 3-Methoxypterostilbene is a naturally occurring stilbene with potential in the treatment of diabetes. The preclinical pharmacokinetics and pharmacodynamics of 3-methoxypterostilbene were evaluated in the present stud...
PMC8957251
core_pubmed_pmc
PKQuest: PBPK modeling of highly lipid soluble and extracellular solutes
PKQuest: PBPK modeling of highly lipid soluble and extracellular solutes Abstract One of the primary objectives of physiologically based pharmacokinetics (PBPK) is the prediction of a drug’s pharmacokinetics just from knowledge of its physicochemical structure. Unfortunately, at present, the accuracy of this prediction...
PMC12888880
core_pubmed_pmc
Pharmacokinetics and safety of fosfomycin and flomoxef administered as part of neonatal sepsis treatment (NeoSep1 Part 1)
Pharmacokinetics and safety of fosfomycin and flomoxef administered as part of neonatal sepsis treatment (NeoSep1 Part 1) Abstract ABSTRACT Neonatal doses for the off-patent antibiotics fosfomycin and flomoxef, which offer coverage against many extended-spectrum beta-lactamase (ESBL)-producing organisms, are based on l...
PMC10243693
core_pubmed_pmc
A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-po...
A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-po...
PMC7139214
core_pubmed_pmc
Effect of belimumab on proteinuria and anti-phospholipase A2 receptor autoantibody in primary membranous nephropathy
Effect of belimumab on proteinuria and anti-phospholipase A2 receptor autoantibody in primary membranous nephropathy Abstract Abstract Background Immunosuppressant drugs reduce proteinuria and anti-phospholipase A2 receptor autoantibodies (PLA2R-Ab) in primary membranous nephropathy (PMN) with varying success and assoc...
PMC9032381
core_pubmed_pmc
Relationship between Biodistribution and Tracer Kinetics of 11 C-Erlotinib, 18 F-Afatinib and 11 C-Osimertinib and Image Quality Evaluation Using Pharmacokinetic/Pharmacodynamic Analysis in Advanced Stage Non-Small Cell Lung Cancer Patients
Relationship between Biodistribution and Tracer Kinetics of 11 C-Erlotinib, 18 F-Afatinib and 11 C-Osimertinib and Image Quality Evaluation Using Pharmacokinetic/Pharmacodynamic Analysis in Advanced Stage Non-Small Cell Lung Cancer Patients Abstract Abstract Background: Patients with non-small cell lung cancer (NSCLC) ...
PMC2987775
core_pubmed_pmc
Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation
Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation Abstract Abstract Background Somatropin is recombinant human growth hormone (GH) used for the treatment of growth failure in children and GH ...
PMC8989837
core_pubmed_pmc
Phase 1b/3 Pharmacokinetics and Safety Study of Intravenous Posaconazole in Adult Asian Participants at High Risk for Invasive Fungal Infections
Phase 1b/3 Pharmacokinetics and Safety Study of Intravenous Posaconazole in Adult Asian Participants at High Risk for Invasive Fungal Infections Abstract Abstract Introduction Antifungal prophylaxis in patients at high risk for invasive fungal infections (IFIs), such as those with acute myeloid leukemia or myelodysplas...
PMC8841454
core_pubmed_pmc
A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults
A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults Abstract Abstract GLH8NDE, a derivative of eupatilin, is currently under development to treat dry eye disease. We conducted a randomized, double‐masked, placebo‐controlled, single‐...
PMC3952820
core_pubmed_pmc
Spatio-Temporal Simulation of First Pass Drug Perfusion in the Liver
Spatio-Temporal Simulation of First Pass Drug Perfusion in the Liver Abstract Abstract The liver is the central organ for detoxification of xenobiotics in the body. In pharmacokinetic modeling, hepatic metabolization capacity is typically quantified as hepatic clearance computed as degradation in well-stirred compartme...
PMC4909717
core_pubmed_pmc
Recent developments in using mechanistic cardiac modelling for drug safety evaluation
Recent developments in using mechanistic cardiac modelling for drug safety evaluation Abstract Highlights • Modelling and simulation can streamline decision making in drug safety testing. • Computational cardiac electrophysiology is a mature technology with a long heritage. • There are many challenges and opportunities...
PMC4759708
core_pubmed_pmc
Population PK‐PD Model for Tolerance Evaluation to the p38 MAP Kinase Inhibitor BCT197
Population PK‐PD Model for Tolerance Evaluation to the p38 MAP Kinase Inhibitor BCT197 Abstract The p38 mitogen‐activated protein kinase (p38) is a key signaling pathway involved in regulation of inflammatory cytokines. Unexpectedly, several clinical studies using p38 inhibitors found no convincing clinical efficacy in...
PMC8453761
core_pubmed_pmc
Pharmacogenomics and Morphine
Pharmacogenomics and Morphine Abstract Abstract Morphine is an opioid analgesic indicated in the treatment of acute and chronic moderate to severe pain. From a pharmacodynamic standpoint, morphine exerts its effects by agonizing mu‐opioid receptors predominantly, resulting in analgesia and sedation. Pharmacokinetically...
PMC10968545
core_pubmed_pmc
Comparing the Efficacy of Two Generations of EGFR-TKIs: An Integrated Drug–Disease Mechanistic Model Approach in EGFR-Mutated Lung Adenocarcinoma
Comparing the Efficacy of Two Generations of EGFR-TKIs: An Integrated Drug–Disease Mechanistic Model Approach in EGFR-Mutated Lung Adenocarcinoma Abstract Mutationsin epidermal growth factor receptor (EGFR) are found in approximately 48% of Asian and 19% of Western patients with lung adenocarcinoma (LUAD), leading to a...
PMC6949284
core_pubmed_pmc
Non-invasive molecular tracking method that measures ocular drug distribution in non-human primates
Non-invasive molecular tracking method that measures ocular drug distribution in non-human primates Abstract Abstract Intravitreal (IVT) injection has become the standard route for drug administration in retinal diseases. However, the ability to measure biodistribution of ocular therapeutics in large species remains li...
PMC3066409
core_pubmed_pmc
Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallel-group, single-dose study in healthy subjects
Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallel-group, single-dose study in healthy subjects Abstract Aims Transient nausea and, to a lesser extent, vomiting are common adverse effects of exenatide that can ...
PMC9424025
core_pubmed_pmc
Mesenchymal Stem Cells (MSCs): A Novel Therapy for Type 2 Diabetes
Mesenchymal Stem Cells (MSCs): A Novel Therapy for Type 2 Diabetes Abstract Although plenty of drugs are currently available for type 2 diabetes mellitus (T2DM), a subset of patients still failed to restore normoglycemia. Recent studies proved that symptoms of T2DM patients who are unresponsive to conventional medicati...
PMC12597941
core_pubmed_pmc
Proanthocyanidins from Ginkgo biloba extract EGb 761 ® exert antioxidative activity in vitro and antiamnesic activity in vivo
Proanthocyanidins from Ginkgo biloba extract EGb 761 ® exert antioxidative activity in vitro and antiamnesic activity in vivo Abstract Abstract Introduction Extracts from Ginkgo biloba leaves are widely used in the treatment of age-related cognitive decline. As regulated herbal medicinal products, these extracts are ad...
PMC10777435
core_pubmed_pmc
Risankizumab: Mechanism of action, clinical and translational science
Risankizumab: Mechanism of action, clinical and translational science Abstract Abstract Risankizumab is a high‐affinity neutralizing anti‐interleukin (IL)‐23 monoclonal antibody marketed in over 40 countries across the globe to treat several inflammatory diseases, such as plaque psoriasis (PsO), psoriatic arthritis (Ps...
PMC12405346
core_pubmed_pmc
Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapy
Meropenem and piperacillin/tazobactam optimised dosing regimens for critically ill patients receiving renal replacement therapy Abstract Abstract Purpose Optimal dosing of meropenem and piperacillin/tazobactam in critically ill patients receiving renal replacement therapy (RRT) is uncertain due to variable pharmacokine...
PMC12439287
core_pubmed_pmc
Prediction of a CLDN18.2 Targeted Antibody Drug Conjugate Pharmacokinetics in Cancer Patients Using PBPK Modeling and Simulation
Prediction of a CLDN18.2 Targeted Antibody Drug Conjugate Pharmacokinetics in Cancer Patients Using PBPK Modeling and Simulation Abstract ABSTRACT Antibody‐drug conjugates (ADCs) represent a promising anticancer approach. Although physiologically based pharmacokinetics (PBPK) modeling became essential in Pharmacometric...
PMC9144420
core_pubmed_pmc
Mathematical Modeling of Hydroxyurea Therapy in Individuals with Sickle Cell Disease
Mathematical Modeling of Hydroxyurea Therapy in Individuals with Sickle Cell Disease Abstract Abstract Sickle cell disease (SCD) is a chronic hemolytic anemia affecting millions worldwide with acute and chronic clinical manifestations and early mortality. While hydroxyurea (HU) and other treatment strategies managed to...
PMC7406431
core_pubmed_pmc
Hispolon: A natural polyphenol and emerging cancer killer by multiple cellular signaling pathways
Hispolon: A natural polyphenol and emerging cancer killer by multiple cellular signaling pathways Abstract Abstract Nature as an infinite treasure of chemotypes and pharmacophores will continue to play an imperative role in the drug discovery. Natural products (NPs) such as plant and fungal metabolites have emerged as ...
PMC6749994
core_pubmed_pmc
3,5,4′-trimethoxy-trans-stilbene loaded PEG-PE micelles for the treatment of colon cancer
3,5,4′-trimethoxy-trans-stilbene loaded PEG-PE micelles for the treatment of colon cancer Abstract Background 3,5,4′-trimethoxy-trans-stilbene (BTM) is a methylated derivative of resveratrol. To improve the pharmaceutical properties of BTM, BTM loaded PEG-PE micelles (BTM@PEG-PE) were fabricated and its anti-cancer eff...
PMC12030206
core_pubmed_pmc
Bridging the Gap Between hiPSC-CMs Cardiotoxicity Assessment and Clinical LVEF Decline Risk: A Case Study of 21 Tyrosine Kinase Inhibitors
Bridging the Gap Between hiPSC-CMs Cardiotoxicity Assessment and Clinical LVEF Decline Risk: A Case Study of 21 Tyrosine Kinase Inhibitors Abstract Abstract Objectives : There is growing concern over tyrosine kinase inhibitor (TKI)-induced cardiotoxicity, particularly regarding left ventricular dysfunction and heart fa...
PMC6882477
core_pubmed_pmc
Oral delivery of lycopene-loaded microemulsion for brain-targeting: preparation, characterization, pharmacokinetic evaluation and tissue distribution
Oral delivery of lycopene-loaded microemulsion for brain-targeting: preparation, characterization, pharmacokinetic evaluation and tissue distribution Abstract Abstract Lycopene is considered as a promising neuroprotector with multiple bioactivities, while its therapeutic use in neurological disorders is restricted due ...
PMC4461388
core_pubmed_pmc
First-in-man Study With Inclacumab, a Human Monoclonal Antibody Against P-selectin
First-in-man Study With Inclacumab, a Human Monoclonal Antibody Against P-selectin Abstract Abstract: Inclacumab, a novel monoclonal antibody against P-selectin in development for the treatment and prevention of atherosclerotic cardiovascular diseases, was administered in an ascending single-dose study as intravenous i...
PMC8950611
core_pubmed_pmc
Clinical Pharmacokinetic Assessment of Kratom ( Mitragyna speciosa ), a Botanical Product with Opioid-like Effects, in Healthy Adult Participants
Clinical Pharmacokinetic Assessment of Kratom ( Mitragyna speciosa ), a Botanical Product with Opioid-like Effects, in Healthy Adult Participants Abstract Increasing use of the botanical kratom to self-manage opioid withdrawal and pain has led to increased kratom-linked overdose deaths. Despite these serious safety con...
PMC12041027
core_pubmed_pmc
Computational identification of potential natural terpenoid inhibitors of MDM2 for breast cancer therapy: molecular docking, molecular dynamics simulation, and ADMET analysis
Computational identification of potential natural terpenoid inhibitors of MDM2 for breast cancer therapy: molecular docking, molecular dynamics simulation, and ADMET analysis Abstract Background Breast cancer (BC) remains a leading cause of cancer-related mortality in women. The oncoprotein MDM2 negatively regulates th...
PMC6718009
core_pubmed_pmc
Clinical Pharmacokinetics of Sulfobutylether‐β‐Cyclodextrin in Patients With Varying Degrees of Renal Impairment
Clinical Pharmacokinetics of Sulfobutylether‐β‐Cyclodextrin in Patients With Varying Degrees of Renal Impairment Abstract Abstract Delafloxacin, a fluoroquinolone, has activity against Gram‐positive organisms including methicillin‐resistant S aureus and fluoroquinolone‐susceptible and ‐resistant Gram‐negative organisms...
PMC5783106
core_pubmed_pmc
Pharmacokinetics-based clinical management of acquired von Willebrand syndrome: a case report
Pharmacokinetics-based clinical management of acquired von Willebrand syndrome: a case report Abstract Abstract von Willebrand disease (VWD) is a common bleeding disorder caused by defective or low levels of von Willebrand factor (VWF). Although most cases of VWD are caused by genetic mutations, some are acquired due t...
PMC11446596
core_pubmed_pmc
Evaluation of Vancomycin Dose Needed to Achieve 24-Hour Area Under the Concentration-Time Curve to Minimum Inhibitory Concentration Ratio Greater Than or Equal to 400 Using Pharmacometric Approaches in Pediatric Intensive Care Patients
Evaluation of Vancomycin Dose Needed to Achieve 24-Hour Area Under the Concentration-Time Curve to Minimum Inhibitory Concentration Ratio Greater Than or Equal to 400 Using Pharmacometric Approaches in Pediatric Intensive Care Patients Abstract OBJECTIVES: To investigate which independent factor(s) have an impact on th...
PMC11393053
core_pubmed_pmc
Model-Informed Development of a Cost-Saving Dosing Regimen for Sacituzumab Govitecan
Model-Informed Development of a Cost-Saving Dosing Regimen for Sacituzumab Govitecan Abstract Background The antibody–drug conjugate sacituzumab govitecan is approved for metastatic triple-negative breast cancer and has shown promising results in various other types of cancer. Its costs may limit patient access to this...
PMC8651550
core_pubmed_pmc
Research Advances in Pharmacology, Safety, and Clinical Applications of Yunnan Baiyao, a Traditional Chinese Medicine Formula
Research Advances in Pharmacology, Safety, and Clinical Applications of Yunnan Baiyao, a Traditional Chinese Medicine Formula Abstract Ethnopharmacology relevance: Yunnan Baiyao (YNBY), a traditional Chinese medicine formulae, has some significant properties including activating blood circulation to dissipate blood sta...
PMC9520388
core_pubmed_pmc
Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01): Protocol for a Phase IV Clinical Trial With a Single Treatment Arm
Bronchopulmonary Penetration of Isavuconazole in Pulmonary Transplant Recipients (PBISA01): Protocol for a Phase IV Clinical Trial With a Single Treatment Arm Abstract Abstract Background Aspergillosis is the most frequently observed invasive fungal disease (IFD) in lung transplant recipients. Isavuconazole (ISA) has s...
PMC4513218
core_pubmed_pmc
Effects of Pharmacogenetics on the Pharmacokinetics and Pharmacodynamics of Tamoxifen
Effects of Pharmacogenetics on the Pharmacokinetics and Pharmacodynamics of Tamoxifen Abstract Abstract The antiestrogenic drug tamoxifen is widely used in the treatment of estrogen receptor-α-positive breast cancer and substantially decreases recurrence and mortality rates. However, high interindividual variability in...
PMC10917414
core_pubmed_pmc
Pseudo-Ludwig’s Angina: Spontaneous Sublingual Haematoma Elicited by Warfarin
Pseudo-Ludwig’s Angina: Spontaneous Sublingual Haematoma Elicited by Warfarin Abstract Spontaneous bleeding into the upper airways is a rare and potentially life-threatening complication of chronic anticoagulation. There are scarce cases in the literature demonstrating upper airway haematomas secondary to warfarin use,...
PMC12569561
core_pubmed_pmc
Characterizing local and systemic exposure to clobetasol propionate in healthy subjects and patients with atopic dermatitis
Characterizing local and systemic exposure to clobetasol propionate in healthy subjects and patients with atopic dermatitis Abstract Abstract Aims There is a potential risk of systemic side‐effects with the use of potent corticosteroids, such as clobetasol propionate (CP). This concern is of particular interest in paed...
PMC4524704
core_pubmed_pmc
Multilevel Nonlinear Mixed-Effect Crown Ratio Models for Individual Trees of Mongolian Oak ( Quercus mongolica ) in Northeast China
Multilevel Nonlinear Mixed-Effect Crown Ratio Models for Individual Trees of Mongolian Oak ( Quercus mongolica ) in Northeast China Abstract In this study, an individual tree crown ratio (CR) model was developed with a data set from a total of 3134 Mongolian oak ( Quercus mongolica ) trees within 112 sample plots alloc...
PMC8326409
core_pubmed_pmc
A Guidance for Concomitant Drug Reconciliation Prior to Allogeneic Hematopoietic Cell Transplantation in Children and Young Adults
A Guidance for Concomitant Drug Reconciliation Prior to Allogeneic Hematopoietic Cell Transplantation in Children and Young Adults Abstract Abstract Pediatric diseases treated by allogeneic hematopoietic stem cell transplantation (alloHCT) are complex and associated with significant comorbidities and medication require...
PMC8449763
core_pubmed_pmc
A phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma
A phase I, single-center, open-label study of RM-1929 photoimmunotherapy in Japanese patients with recurrent head and neck squamous cell carcinoma Abstract Background To determine the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of a single cycle of RM-1929 photoimmunotherapy, an anti-EGFR antibod...
PMC6882724
core_pubmed_pmc
Pharmacokinetics of intravenous administered two different high doses of ascorbic acid in healthy beagle dogs
Pharmacokinetics of intravenous administered two different high doses of ascorbic acid in healthy beagle dogs Abstract Objective: We performed a randomized two-way crossover study to evaluate the pharmacokinetic profiles of two high-dose ascorbic acid (AA) after IV infusion in healthy beagle dogs. Materials and Methods...
PMC5728060
core_pubmed_pmc
Ibuprofen plasma concentration profile in deliberate ibuprofen overdose with circulatory depression treated with therapeutic plasma exchange: a case report
Ibuprofen plasma concentration profile in deliberate ibuprofen overdose with circulatory depression treated with therapeutic plasma exchange: a case report Abstract Background Inquiries relating to ibuprofen overdose have more than tripled in the last ten years in our poison control center. Although the vast majority o...
PMC10887887
core_pubmed_pmc
The Subcutaneous Administration of Beta-Lactams: A Case Report and Literary Review—To Do Small Things in a Great Way
The Subcutaneous Administration of Beta-Lactams: A Case Report and Literary Review—To Do Small Things in a Great Way Abstract The subcutaneous (s.c.) route is a commonly used method for delivering various drugs, although its application in the administration of antibiotics is relatively uncommon. In this case, we repor...
PMC3392795
core_pubmed_pmc
Is there any scientific evidence for the use of glucosamine in the management of human osteoarthritis?
Is there any scientific evidence for the use of glucosamine in the management of human osteoarthritis? Abstract Abstract Glucosamine in its acetylated form is a natural constituent of some glycosaminoglycans (for example, hyaluronic acid and keratan sulfate) in the proteoglycans found in articular cartilage, interverte...
PMC8707165
core_pubmed_pmc
Antisense Oligonucleotide-Based Therapy of Viral Infections
Antisense Oligonucleotide-Based Therapy of Viral Infections Abstract Abstract Nucleic acid-based therapeutics have demonstrated their efficacy in the treatment of various diseases and vaccine development. Antisense oligonucleotide (ASO) technology exploits a single-strand short oligonucleotide to either cause target RN...
PMC11578124
core_pubmed_pmc
Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine
Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine Modeling MODEL‐INFORMED DRUG DEVELOPMENT FOR PREGNANT INDIVIDUALS Model‐informed drug development (MIDD) methods are a selection of various quantitative methods that help to balance the...
PMC4449380
core_pubmed_pmc
Absence of Drug–Drug Interactions Between Luseogliflozin, a Sodium–Glucose Co-transporter-2 Inhibitor, and Various Oral Antidiabetic Drugs in Healthy Japanese Males
Absence of Drug–Drug Interactions Between Luseogliflozin, a Sodium–Glucose Co-transporter-2 Inhibitor, and Various Oral Antidiabetic Drugs in Healthy Japanese Males Abstract Abstract Introduction We investigated the possibilities of drug–drug interactions between luseogliflozin, a sodium–glucose co-transporter-2 inhibi...
PMC12777561
core_pubmed_pmc
Predicting prolonged dalbavancin exposure using machine learning: a validated strategy for individualized redosing
Predicting prolonged dalbavancin exposure using machine learning: a validated strategy for individualized redosing Abstract ABSTRACT Dalbavancin is a long-acting lipoglycopeptide increasingly used off-label for complex Gram-positive infections requiring prolonged therapy. Its extended half-life enables simplified regim...
PMC5035013
core_pubmed_pmc
Pharmacodynamic Impact of Carboxylesterase 1 Gene Variants in Patients with Congestive Heart Failure Treated with Angiotensin-Converting Enzyme Inhibitors
Pharmacodynamic Impact of Carboxylesterase 1 Gene Variants in Patients with Congestive Heart Failure Treated with Angiotensin-Converting Enzyme Inhibitors Abstract Abstract Background Variation in the carboxylesterase 1 gene (CES1) may contribute to the efficacy of ACEIs. Accordingly, we examined the impact of CES1 var...
PMC7979639
core_pubmed_pmc
Exact solutions and equi-dosing regimen regions for multi-dose pharmacokinetics models with transit compartments
Exact solutions and equi-dosing regimen regions for multi-dose pharmacokinetics models with transit compartments Abstract Compartmental models which yield linear ordinary differential equations (ODEs) provide common tools for pharmacokinetics (PK) analysis, with exact solutions for drug levels or concentrations readily...
PMC8315226
core_pubmed_pmc
Antiviral Drug Delivery System for Enhanced Bioactivity, Better Metabolism and Pharmacokinetic Characteristics
Antiviral Drug Delivery System for Enhanced Bioactivity, Better Metabolism and Pharmacokinetic Characteristics Abstract Abstract Antiviral drugs (AvDs) are the primary resource in the global battle against viruses, including the recent fight against corona virus disease 2019 (COVID-19). Most AvDs require multiple medic...
PMC6071451
core_pubmed_pmc
Pharmacokinetic Studies of Factor VIII in Chinese Boys with Severe Hemophilia A: A Single-Center Study
Pharmacokinetic Studies of Factor VIII in Chinese Boys with Severe Hemophilia A: A Single-Center Study Abstract Background: Although much attention has been paid to the pharmacokinetics (PKs) of different factor VIII (FVIII) concentrates in persons with hemophilia A (HA), limited information is available in young boys ...
PMC8846636
core_pubmed_pmc
SAMBA: A novel method for fast automatic model building in nonlinear mixed‐effects models
SAMBA: A novel method for fast automatic model building in nonlinear mixed‐effects models Abstract Abstract The success of correctly identifying all the components of a nonlinear mixed‐effects model is far from straightforward: it is a question of finding the best structural model, determining the type of relationship ...
PMC7154716
core_pubmed_pmc
A Phase 1, Randomized, Open‐Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects
A Phase 1, Randomized, Open‐Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects Abstract Objective To investigate and compare the safety and the pharmacok...
PMC5306265
core_pubmed_pmc
A phase I dose-escalation study of TAK-733, an investigational oral MEK inhibitor, in patients with advanced solid tumors
A phase I dose-escalation study of TAK-733, an investigational oral MEK inhibitor, in patients with advanced solid tumors Abstract Summary Purpose TAK-733, an investigational, selective, allosteric MEK1/2 inhibitor, has demonstrated antitumor effects against multiple cancer cell lines and xenograft models. This first-i...
PMC4429575
core_pubmed_pmc
Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation
Physiologically Based Models in Regulatory Submissions: Output From the ABPI/MHRA Forum on Physiologically Based Modeling and Simulation Abstract Abstract Under the remit of the Ministerial Industry Strategy Group (MISG), the Association of the British Pharmaceutical Industry (ABPI) and Medicines and Healthcare product...
PMC10550146
core_pubmed_pmc
Mechanistic characterization of oscillatory patterns in unperturbed tumor growth dynamics: The interplay between cancer cells and components of tumor microenvironment
Mechanistic characterization of oscillatory patterns in unperturbed tumor growth dynamics: The interplay between cancer cells and components of tumor microenvironment Abstract Abstract Mathematical modeling of unperturbed and perturbed tumor growth dynamics (TGD) in preclinical experiments provides an opportunity to es...
PMC9055091
core_pubmed_pmc
Pharmacokinetic–pharmacodynamic modeling for Moutan Cortex/Moutan Cortex charcoal and the contributions of the chemical component using support vector regression with particle swarm optimization
Pharmacokinetic–pharmacodynamic modeling for Moutan Cortex/Moutan Cortex charcoal and the contributions of the chemical component using support vector regression with particle swarm optimization Abstract Moutan Cortex (MC) and Moutan Cortex charcoal (MCC) are two kinds of Chinese medicinal materials widely used in trad...
PMC12231637
core_pubmed_pmc
Modelling the impact of initiation delay, duration and prior PrEP on the efficacy of post‐exposure prophylaxis containing a tenofovir/emtricitabine backbone
Modelling the impact of initiation delay, duration and prior PrEP on the efficacy of post‐exposure prophylaxis containing a tenofovir/emtricitabine backbone Abstract Abstract Introduction Pre‐ and post‐exposure prophylaxis (PrEP and PEP) are important pillars of the HIV prevention portfolio to reduce the risk of acquis...
PMC8562592
core_pubmed_pmc
Untargeted Large Volume Hyperthermia Reduces Tumor Drug Uptake From Thermosensitive Liposomes
Untargeted Large Volume Hyperthermia Reduces Tumor Drug Uptake From Thermosensitive Liposomes Abstract Abstract Goal: The impact of hyperthermia (HT) method on tumor drug uptake with thermosensitive liposomes (TSL) is not well understood. Methods: We created realistic three-dimensional (3-D) computer models that simula...
PMC3156126
core_pubmed_pmc
Comparison of the Safety and Pharmacokinetics of ST-246® after IV Infusion or Oral Administration in Mice, Rabbits and Monkeys
Comparison of the Safety and Pharmacokinetics of ST-246® after IV Infusion or Oral Administration in Mice, Rabbits and Monkeys Abstract Background ST-246® is an antiviral, orally bioavailable small molecule in clinical development for treatment of orthopoxvirus infections. An intravenous (IV) formulation may be require...
PMC11590932
core_pubmed_pmc
The Pharmacokinetics of Δ 9 -Tetrahydrocannabinol in Sheep
The Pharmacokinetics of Δ 9 -Tetrahydrocannabinol in Sheep Abstract Simple Summary Industrial hemp biomass, the low Δ 9 -tetrahydrocannabinol variety of Cannabis sativa , has been identified as a potential feed for ruminants. To be a viable option for ruminants involved in the food chain, industrial hemp biomass needs ...
PMC6791502
core_pubmed_pmc
Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations
Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations Abstract Objectives IPX203 is an investigational oral extended-release capsule formulation of carbidopa and levodopa. The pharmacodynamics and efficacy of IPX203 were compared with immediate-release carbidopa-levodopa...
PMC6471571
core_pubmed_pmc
QT Assessment in Early Drug Development: The Long and the Short of It
QT Assessment in Early Drug Development: The Long and the Short of It Abstract The QT interval occupies a pivotal role in drug development as a surface biomarker of ventricular repolarization. The electrophysiologic substrate for QT prolongation coupled with reports of non-cardiac drugs producing lethal arrhythmias cap...
PMC9201389
core_pubmed_pmc
Liposomes are Poorly Absorbed via Lung Lymph After Inhaled Administration in Sheep
Liposomes are Poorly Absorbed via Lung Lymph After Inhaled Administration in Sheep Abstract Enhancing the delivery of therapeutic agents to the lung lymph, including drugs, transfection agents, vaccine antigens and vectors, has the potential to significantly improve the treatment and prevention of a range of lung-relat...
PMC9220862
core_pubmed_pmc
Microfluidic Organ-on-a-Chip System for Disease Modeling and Drug Development
Microfluidic Organ-on-a-Chip System for Disease Modeling and Drug Development Abstract Abstract An organ-on-a-chip is a device that combines micro-manufacturing and tissue engineering to replicate the critical physiological environment and functions of the human organs. Therefore, it can be used to predict drug respons...
PMC6282491
core_pubmed_pmc
Dosing of Ceftriaxone and Metronidazole for Children With Severe Acute Malnutrition
Dosing of Ceftriaxone and Metronidazole for Children With Severe Acute Malnutrition Abstract Abstract Infants and young children with severe acute malnutrition (SAM) are treated with empiric broad‐spectrum antimicrobials. Parenteral ceftriaxone is currently a second‐line agent for invasive infection. Oral metronidazole...
PMC12888873
core_pubmed_pmc
Evaluation of cerebrospinal fluid penetration of delafloxacin in a murine model
Evaluation of cerebrospinal fluid penetration of delafloxacin in a murine model Abstract ABSTRACT Cerebrospinal fluid (CSF) penetration of delafloxacin was evaluated in a murine model. Mice received a single 40 mg/kg intraperitoneal dose. Plasma and CSF samples were collected at five time points over 4 h and analyzed b...
PMC10587779
core_pubmed_pmc
Terlipressin for the Prevention and Treatment of Renal Decline in Hepatorenal Syndrome: A Drug Profile
Terlipressin for the Prevention and Treatment of Renal Decline in Hepatorenal Syndrome: A Drug Profile Abstract Hepatorenal syndrome stands as one of several potential triggers of acute kidney injury in individuals grappling with either acute or persistent liver ailments. The nature of the decline in kidney function ha...
PMC8565336
core_pubmed_pmc
Overcoming GNA/RNA base-pairing limitations using isonucleotides improves the pharmacodynamic activity of ESC+ GalNAc-siRNAs
Overcoming GNA/RNA base-pairing limitations using isonucleotides improves the pharmacodynamic activity of ESC+ GalNAc-siRNAs Abstract Abstract We recently reported that RNAi-mediated off-target effects are important drivers of the hepatotoxicity observed for a subset of GalNAc–siRNA conjugates in rodents, and that thes...
PMC7589886
core_pubmed_pmc
Enhanced Lymphatic Delivery of Methotrexate Using W/O/W Nanoemulsion: In Vitro Characterization and Pharmacokinetic Study
Enhanced Lymphatic Delivery of Methotrexate Using W/O/W Nanoemulsion: In Vitro Characterization and Pharmacokinetic Study Abstract Methotrexate, which is widely used in the treatment of cancer and immune-related diseases, has limitations in use because of its low bioavailability, short half-life, and tissue toxicity. T...
PMC8911401
core_pubmed_pmc
Clinical Relevance of Drug Interactions with Cannabis: A Systematic Review
Clinical Relevance of Drug Interactions with Cannabis: A Systematic Review Abstract Concomitant use of cannabis with other drugs may lead to cannabis–drug interactions, mainly due to the pharmacokinetic mechanism involving the family of CYP450 isoenzymes. This narrative systematic review aimed to systematize the availa...
PMC9067474
core_pubmed_pmc
Physiologically Based Modeling to Predict Monoclonal Antibody Pharmacokinetics in Humans from in vitro Physiochemical Properties
Physiologically Based Modeling to Predict Monoclonal Antibody Pharmacokinetics in Humans from in vitro Physiochemical Properties Abstract ABSTRACT A model-based framework is presented to predict monoclonal antibody (mAb) pharmacokinetics (PK) in humans based on in vitro measures of antibody physiochemical properties. A...
PMC7245990
core_pubmed_pmc
Structure-based drug designing for potential antiviral activity of selected natural products from Ayurveda against SARS-CoV-2 spike glycoprotein and its cellular receptor
Structure-based drug designing for potential antiviral activity of selected natural products from Ayurveda against SARS-CoV-2 spike glycoprotein and its cellular receptor Abstract The recent outbreak of COVID-19 caused by SARS-CoV-2 brought a great global public health and economic concern. SARS-CoV-2 is an enveloped R...
PMC12289361
core_pubmed_pmc
Safety, Tolerability, and Pharmacokinetics of NorUrsodeoxycholic Acid (Shilpa Medicare Limited, India) in Healthy Adults: Results From a Phase I Open-Label Dose-Escalation Study
Safety, Tolerability, and Pharmacokinetics of NorUrsodeoxycholic Acid (Shilpa Medicare Limited, India) in Healthy Adults: Results From a Phase I Open-Label Dose-Escalation Study Abstract NorUrsodeoxycholic acid (norUDCA) is a side-chain-shortened derivative of ursodeoxycholic acid (UDCA) with specific pharmacological p...
PMC11298173
core_pubmed_pmc
Insights on Nefecon ® , a Targeted-Release Formulation of Budesonide and Its Selective Immunomodulatory Effects in Patients with IgA Nephropathy
Insights on Nefecon ® , a Targeted-Release Formulation of Budesonide and Its Selective Immunomodulatory Effects in Patients with IgA Nephropathy Abstract Abstract Immunoglobulin A nephropathy (IgAN) is a chronic, immune-mediated kidney disease characterized by the deposition of galactose-deficient immunoglobulin A1 (Gd...
PMC9004730
core_pubmed_pmc
Plasma and Intrapulmonary Pharmacokinetics, and Dosage Regimen Optimization of Linezolid for Treatment of Gram-Positive Cocci Infections in Patients with Pulmonary Infection After Cerebral Hemorrhage
Plasma and Intrapulmonary Pharmacokinetics, and Dosage Regimen Optimization of Linezolid for Treatment of Gram-Positive Cocci Infections in Patients with Pulmonary Infection After Cerebral Hemorrhage Abstract Purpose The objective of this study was to perform pharmacokinetics/pharmacodynamics (PK/PD) analysis of linezo...
PMC5063144
core_pubmed_pmc
Pharmacokinetics of serelaxin in patients with severe renal impairment or end‐stage renal disease requiring hemodialysis: A single‐dose, open‐label, parallel‐group study
Pharmacokinetics of serelaxin in patients with severe renal impairment or end‐stage renal disease requiring hemodialysis: A single‐dose, open‐label, parallel‐group study Abstract Abstract Serelaxin, a recombinant human relaxin‐2 hormone, is in clinical development for treating acute heart failure. This open‐label, para...
PMC8813705
core_pubmed_pmc
Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model
Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model Abstract Abstract Background Tadalafil 40 mg once daily is approved for adult patients with pulmonary arterial hypertension (PAH). To investigate and potentially fulfill an unmet need in...
PMC3349182
core_pubmed_pmc
A phase I study of E7080, a multitargeted tyrosine kinase inhibitor, in patients with advanced solid tumours
A phase I study of E7080, a multitargeted tyrosine kinase inhibitor, in patients with advanced solid tumours Abstract Background: The objectives of this phase I study were to assess the safety and tolerability of E7080 in patients with advanced, refractory solid tumours; to determine the maximum tolerated dose (MTD) an...
PMC8189951
core_pubmed_pmc
A Randomized Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of the Novel Myostatin Inhibitor Apitegromab (SRK-015): A Potential Treatment for Spinal Muscular Atrophy
A Randomized Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of the Novel Myostatin Inhibitor Apitegromab (SRK-015): A Potential Treatment for Spinal Muscular Atrophy Abstract Introduction Apitegromab (SRK-015) is an anti-promyostatin monoclonal antibody under development to improve motor function in patients...
PMC7984209
core_pubmed_pmc
Categorisation of Pharmaceutical Adverse Events Using the Japanese Adverse Drug Event Report Database: Characteristic Adverse Drug Events of the Elderly Treated with Polypharmacy
Categorisation of Pharmaceutical Adverse Events Using the Japanese Adverse Drug Event Report Database: Characteristic Adverse Drug Events of the Elderly Treated with Polypharmacy Abstract Background Pharmacokinetics and pharmacodynamics of drugs in elderly individuals differ from those in younger adults; thus, adverse ...
PMC4243433
core_pubmed_pmc
Development and Validation of a Rapid Turbidimetric Assay to Determine the Potency of Cefuroxime Sodium in Powder for Injection
Development and Validation of a Rapid Turbidimetric Assay to Determine the Potency of Cefuroxime Sodium in Powder for Injection Abstract Abstract The cefuroxime sodium is a second generation cephalosporin indicated for infections caused by Gram-positive and Gram-negative microorganisms. Although this drug is highly stu...
PMC8374020
core_pubmed_pmc
Dosimetric impact of Ac-227 in accelerator-produced Ac-225 for alpha-emitter radiopharmaceutical therapy of patients with hematological malignancies: a pharmacokinetic modeling analysis
Dosimetric impact of Ac-227 in accelerator-produced Ac-225 for alpha-emitter radiopharmaceutical therapy of patients with hematological malignancies: a pharmacokinetic modeling analysis Abstract Background Actinium-225 is an alpha-particle emitter under investigation for use in radiopharmaceutical therapy. To address l...
PMC8354182
core_pubmed_pmc
Square root law model for the delivery and intestinal absorption of drugs: a case of hydrophilic captopril
Square root law model for the delivery and intestinal absorption of drugs: a case of hydrophilic captopril Abstract Abstract The in vivo release and absorption of drugs are dependent on the interplay between many factors related to compound, formulation, and physiological properties. The mathematical models of oral dru...
PMC12852995
core_pubmed_pmc
Optimizing Tedizolid Dosing in Cerebral Nocardiosis: Clinical Impact of Direct Unbound Concentration Measurement and Population PK Modelling in Two Cases
Optimizing Tedizolid Dosing in Cerebral Nocardiosis: Clinical Impact of Direct Unbound Concentration Measurement and Population PK Modelling in Two Cases Abstract Abstract Introduction Tedizolid, a second-generation oxazolidinone, exhibits potent in vitro activity against Gram-positive bacteria, including Nocardia spec...