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A001
Comparison of the Pharmacokinetics/Pharmacodynamics of a Fixed-Dose Combination of Rabeprazole/Magnesium Oxide 20/350 mg to the Enteric-Coated Rabeprazole 20 mg
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A002
A Comparative Review of Study Population & Dose Recommendations for In Vivo Bioequivalence Studies With Pharmacokinetic Endpoints Between FDA & EMA Guidances
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A003
Enhanced HLA-B*15:02 Screening Before Carbamazepine Therapy in Vietnam: Advancements in Real-Time PCR TaqMan Probe Procedure
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A004
Cefepime Population Pharmacokinetics Using Volumetric Absorptive Microsampling in Critically Ill Children With Multiple Organ Dysfunction Syndrome
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A004
Cefepime Population Pharmacokinetics Using Volumetric Absorptive Microsampling in Critically Ill Children With Multiple Organ Dysfunction Syndrome
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A005
Implications of Being Born Small for Gestational Age on the Exposure of Vancomycin & Gentamicin In Neonates
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A005
Implications of Being Born Small for Gestational Age on the Exposure of Vancomycin & Gentamicin In Neonates
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A006
Microfluidic Blood-Milk Barrier & Physiologically-based Pharmacokinetic Model to Predict Lofexidine Secretion into Breast Milk
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A006
Microfluidic Blood-Milk Barrier & Physiologically-based Pharmacokinetic Model to Predict Lofexidine Secretion into Breast Milk
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A007
Dose Optimization of Cefazolin in Adult Cardiac Surgery With Cardiopulmonary Bypass After Albumin Supplementation
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A007
Dose Optimization of Cefazolin in Adult Cardiac Surgery With Cardiopulmonary Bypass After Albumin Supplementation
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A008
Using Clinical Data & Physiologically-based Pharmacokinetic Modelling to Assess the Effect of Hepatic Impairment on Avapritinib Pharmacokinetics to Guide Dose Adjustment
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A008
Using Clinical Data & Physiologically-based Pharmacokinetic Modelling to Assess the Effect of Hepatic Impairment on Avapritinib Pharmacokinetics to Guide Dose Adjustment
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A009
A Translational Platform Quantitative Systems Pharmacology Model for Preclinical to Clinical Translation of In Vivo CRISPR-Cas9 Gene Therapy
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A009
A Translational Platform Quantitative Systems Pharmacology Model for Preclinical to Clinical Translation of In Vivo CRISPR-Cas9 Gene Therapy
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A010
Model-Based Assessment of the Contribution of Fc Proteins & Serum Proteins to the Elevated Clearance of Monoclonal Antibodies
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A010
Model-Based Assessment of the Contribution of Fc Proteins & Serum Proteins to the Elevated Clearance of Monoclonal Antibodies
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011
Evaluation of Prompt Engineering Strategies for Pharmacokinetic Data Analysis With the ChatGPT Large Language Model
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013
Use of Artificial Intelligence in Drug Development
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014
Analyzing the Association Between Single Nucleotide Polymorphisms & Combinations of Buprenorphine & Associated Metabolite Concentrations
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015
Characterizing the Covariates & their Impacts on Statistical Evaluations of Clinical Pharmacology Studies in the 351(k) Biologic License Applications
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016
Comparative Pharmacokinetics & Bioequivalence Study of Gatifloxacin 200mg Tablets
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017
Pharmacist Administered Parenteral Medications: A Descriptive Study of a Novel Inpatient Training Program
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019
Clinical Pharmacology Insights into Dosing Strategies of Approved Antibody-Drug Conjugates
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020
Integration of the National HIV Curriculum at Accredited Graduate Programs of Pharmacy
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021
Strategic & Quantitative Recommendations on Bioanalytical Cross-Validation Experiment Design from a Clinical Pharmacology Perspective
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022
Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants
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023
FDA & EMA Regulatory Recommendations on Fed Bioequivalence Study in Healthy Subjects vs Patients for Generic Drug Development
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024
The Drug-Drug Interaction Effect of Steady State Rifampin Exposure on Single Dose Pharmacokinetics of Lazertinib
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025
No Clinically Meaningful Drug Interaction Between Futibatinib & Digoxin, Rosuvastatin or Quinidine
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026
Phase I Open Label Study to Evaluate the Effects of Savolitinib on the Pharmacokinetics of P-gp, OATP1B1/3, OCT2, MATE1/2K & OAT1/3 Substrates in Healthy Volunteers
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027
A Quantitative Evaluation of the Relationship Between Hepatic Extraction Ratio & Change in Plasma Half-Life Following Modulation of CYP3A Activity
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028
Drug-Drug Interactions of Lirafugratinib
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029
Physiologically-based Pharmacokinetic Modeling of a Novel HER3-Targeted Antibody-Drug Conjugate, Patritumab Deruxtecan to Assess Pharmacokinetic Drug-Drug Interaction
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030
Effects of Itraconazole & Rifampin on Tazemetostat Pharmacokinetics in Patients With Advanced Malignancies
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031
No Increase in the Risk of Liver or Muscle Toxicity in Pegozafermin-treated Patients With Metabolic Dysfunction-Associated Steatohepatitis on Statin Background Therapy
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032
The Effect of an Acid-reducing Agent, Esomeprazole on Sparsentan Pharmacokinetics in Healthy Volunteers
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033
Clinical Assessment of Mocravimod as a Victim of Drug-Drug Interactions via CYP3A Metabolism & Transporters
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034
A Drug-Drug Interaction Study Between ABBV-903 & Midazolam in Healthy Participants
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035
Potential Epigenetic Opioid-Chemotherapy Drug Interactions
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036
Endogenous Biomarker Use in Renal Transporter-Mediated Drug Interactions: A Literature Review of Intrinsic, Extrinsic Factors & Disease Impact on Biomarker Levels
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037
Effect of Omaveloxolone @ Its Metabolites on Corrected QT Interval in Health Subjects
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038
Lorundrostat Concentration-QTc Results from the First-in-Human Study in Healthy Participants Demonstrate Lack of Relevant Effect & Replaces the Thorough QT Study
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039
Incidence & Predictors of Stroke Mimic Amongst Patients Treated With Recombinant Tissue Plasminogen Activator: A Retrospective Comparison
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040
Assessment of Clinical Challenges With Application of Institute for Safe Medication Practices Targeted Medication Safety Best Practice: Injectable Promethazine
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041
Population Modeling Framework With Adaptive Dosing for Optimizing Clinical Utility of Compounds in Development for Treatment of Solid Tumors
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042
Pharmacokinetics & Exposure-safety Analyses Across Tumor Types for Ifinatamab Deruxtecan (I-DXd) in the First-in-Human Study IDeate-Pantumor01 (DS7300-A-J101)
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043
Effects of the Innate Immune System, Body Habitus & Sex on the Pharmacokinetics & Antitumor Response of Anetumab Ravtansine in Patients With Solid Tumors
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044
Effect of Food on the Pharmacokinetics & Safety Profile of p53 Reactivator Rezatapopt in Healthy Subjects & Patients With Solid Tumors Harboring a
TP53
Y220C Mutation
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045
Population Pharmacokinetics of GB-5001, a Long-acting Intramuscular Injection of Donepezil, in Healthy Participants
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046
Exposure-Response Analysis to Inform QT Prolongation Potential for Cedirogant
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047
How Much PK Data Do We Really Need in Phase 3? A Milvexian Case Study
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048
Population Pharmacokinetic and Exposure-response Analyses of anti-BDCA2 Antibody Litifilimab Support Its Clinical Benefit for Cutaneous Lupus Erythematosus
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049
Assessment of the Effect of HBV Viral Genotype on Bepirovirsen Efficacy Using a Population Pharmacokinetic/Pharmacodynamic Modeling Approach
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050
Modeling Effects of Lymphodepletion Therapy on CAR T-cell & Cytokine Dynamics
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051
Pharmacokinetically-Guided Dosing of Fludarabine for Lymphodepletion in CAR T-cell Therapy: A Clinical Trial Simulation Study
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052
Nipocalimab Pharmacokinetic/Pharmacodynamic & Exposure-Response Modeling in Pregnancies at Risk for Early-onset Severe (EOS) HDFN
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053
Concentration-QTc Analysis of Quemliclustat in Combination With/Without Zimberelimab & nab-Paclitaxel/Gemcitabine in Patients With Advanced Pancreatic Cancer
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054
The Effect of Moderate Hepatic Impairment on ONC201 (Dordaviprone) Pharmacokinetics
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055
First-in-Human Population PKPD Modelling & Simulation of CUE-101: Preliminary Results
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056
Quantitative Systems Pharmacology Model Predicts Combination Activity of CD19-targeted Loncastuximab Tesirine With Epcoritamab in B-cell Lymphoma
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057
Quantitative Systems Pharmacology Modeling of Loncastuximab Tesirine Combined With Mosunetuzumab & Glofitamab Guides Dosing in B-cell Lymphoma
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059
Perioperative Antibiotic Prophylaxis in Paediatric Cardiac Surgery – is One Day Sufficient to Prevent Surgical Site Infections?
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060
Pharmacokinetic Modeling of the IRF5 Antisense Oligonucleotide JNJ-66525433 & IRF5 mRNA Expression in Healthy Individuals
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061
First-in-Human Evaluation of Pharmacokinetics & Safety of Tilpisertib Fosmecarbil, an Oral Prodrug of a Tumor Progression Locus 2 Inhibitor, in Healthy Volunteers
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062
Absolute Oral Bioavailability of Nerandomilast in Healthy Male Study Participants
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063
Preclinical & Clinical Pharmacokinetics of JNJ-75220795, A siRNA Therapeutic Targeting
PNPLA3
, for Metabolic-associated Steatohepatitis
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064
Pharmacokinetics of 6-diazo-5-oxo-L-norleucine (DON) in Malawian Healthy Adults & Adults With Uncomplicated Malaria
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065
Clinical Pharmacological Characterization of Cilta-cel, a CAR-T Therapy Directed Against BCMA in Adult Patients With Multiple Myeloma in a Multicohort CARTITUDE-2 Study
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066
Population Pharmacokinetic Analysis of Cenobamate
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067
The Impact of Late-Runner Participants on PK Variability in Healthy Volunteer, Single-Ascending Dose Trials
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068
Pharmacokinetic Analyses & Population Pharmacokinetic Modeling of Maplirpacept in Patients With Newly Diagnosed Acute Myeloid Leukemia
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069
Population Pharmacokinetics of Bictegravir in Pregnant & Postpartum Persons Living With HIV
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070
Population Pharmacokinetic & Exposure-Response Analyses for the Phase 3 PhALLCON Study of Ponatinib in Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia
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071
Evaluation of Palbociclib & Combinatorial Chemotherapy Pharmacokinetics in Pediatric Patients With Recurrent or Refractory Solid Tumors
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072
Pharmacokinetics & Pharmacodynamics of Milvexian After Administration Every 12 Hours in Healthy Subjects
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073
Clinical Pharmacology of Bemarituzumab in Gastric & Gastroesophageal Junction Cancer Patients Supports the Interchangeability of Q2W & Q3W Dosing Regimens
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074
A First-in-Human, Single & Multiple Ascending Dose Study of CK-4021586, A Novel Cardiac Myosin Inhibitor
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075
Population Pharmacokinetics of Trastuzumab Deruxtecan (T-DXd) in Subjects With HER2-mutant & HER2-overexpressing Non-Small Cell Lung Cancer (NSCLC)
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076
First-in-Human Phase 1 SAD, MAD, Food Effect & DDI Study of SGR-1505, a Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1 Inhibitor, in Healthy Volunteers
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077
Advanced Waveform Analysis of ECG Signals to Characterise Cardiac Drug Safety Between Caucasian & Japanese Volunteers
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078
Pharmacokinetics, Pharmacodynamics & Safety of Rusfertide, A Hepcidin Mimetic, in Subjects With Hepatic Impairment & in Subjects With Renal Impairment
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079
Exploring the Impact of Hepatic Impairment on the Pharmacokinetics of New Molecular Entities: A Comprehensive Analysis of Labeling Information
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080
Is it Time to Retire Cockcroft-Gault & “Original” Schwarz Formulas in Drug Development?
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081
Exclusion of Pediatric Patients With Renal Impairment in Clinical Trials for Antiviral Products
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082
Mechanistic Physiologically-based Pharmacokinetic Modeling to Predict Bictegravir Drug Disposition in Pregnancy
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083
Pharmacokinetics of Tenofovir Alafenamide, Emtricitabine & Dolutegravir in a Patient on Peritoneal Dialysis
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084
Exploration of Estimated Renal Function & Gabapentin Clearance in Older Adults
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085
Predicting Metoprolol Exposure-Response in Pregnant Population Using Physiologically-based Pharmacokinetic Modeling
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087
Development of a Pharmacokinetic-Tumor Target Engagement Model Using Nonclinical Data to Inform Phase 1 Dosing Scheme for a Novel Bispecific CD40-EpCAM Antibody, KK2269
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088
Developing a Physiologically-based Pharmacokinetic Model Across Various Species Exploring Drug Interaction Potential of Mitragynine
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089
The Impact of COVID-19 Mediated Bidirectional Dysregulation of CYP3A4 on Systemic & Pulmonary Candidate Drug Concentrations
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090
Pharmacokinetics of Tetrahydrocannabinol in Infants Exposed to Breastmilk from Recreational Cannabis Users
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091
Clinical Pharmacology of Bispecific T-cell Engagers: A Summary Based on FDA Approvals
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092
Concentration-QTc Interim Analysis of I-DXd in Subjects With Advanced Solid Tumors from Study IDeate-Pantumor01 (DS7300-A-J101)
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093
Trends in First-in-Human Trials of Intrathecal Antisense Oligonucleotide Therapies: Insights into Dose Selection, Dose Escalation & Early Clinical Development
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094
Analyzing First-in-Human Trial Designs of Antisense Oligonucleotides: A Preliminary Review Across Subcutaneous, Intravenous & Intrathecal Routes of Administration
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095
A Survey of Pharmacodynamic Biomarkers Bioanalysis in 20 Biologics License Applications Approved for Enzyme Replacement Therapy Indications
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096
Cluster Analysis to Identify Biomarkers of Treatment Response Following Sirolimus Treatment for HIV Cure
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097
Comparison of Hypoxia Inducible Factor-1A Polymorphisms Between Chronic Kidney Disease Patients & Healthy Subjects
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098
CYP2B6 & CYP2C19 Phenotypes Influence Sertraline Exposure in Children & Adolescents
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100
Sex-Related Differences in the Pharmacokinetics of Therapeutic Proteins
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101
The SARS-CoV-2 Mpro Inhibitor Ibuzatrelvir is a Substrate but not an Inducer nor Inhibitor of CYP3A
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102
Sisunatovir Inhibition of Multiple Ion Channel Subtypes Prevents the Risk for QT Prolongation Due to hERG Channel Inhibition
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105
ENA-001, a Novel BK-channel Blocker, Enhances Hypoxic Ventilatory Sensitivity and Alleviates Propofol-induced Respiratory Effects in Healthy Volunteers
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106
First-in-Human Safety, Pharmacokinetics & Pharmacodynamics of the Oral Factor D Inhibitor BCX10013
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107
Pharmacokinetic & Immunogenicity Results from the China Cohort of the MAJESTEC-1 Study of Teclistamab for Relapsed/refractory Multiple Myeloma
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108
Pharmacokinetic Comparison of Ezetimibe/Rosuvastatin/Telmisartan Fixed-dose Combination vs Coadministration of Separate Treatments
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109
Pharmacokinetic Comparison Between Fixed-dose Combination of Rosuvastatin/Ezetimibe 2.5/10 mg & the Coadministration of Individual Formulations in Healthy Subjects
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110
Phase 1, Single-Center, Randomized, Placebo-Controlled, Partially Blinded, Single Ascending Dose Study on the Effects of Troriluzole on corrected QT in Healthy Subjects
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111
Effect of Food on the Pharmacokinetics, Safety & Tolerability of Budesonide Oral Suspension in Healthy Adults: A Randomized Phase 1 Study
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112
Pharmacokinetics & Safety of Teclistamab Administered in the Arm or Thigh of Patients With Relapsed/Refractory Multiple Myeloma in MajesTEC-1
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113
Pharmacokinetics, Safety & Tolerability of GS-1427, a Pro-drug of a Potent & Selective Small-Molecule α4β7 Integrin Inhibitor, in Healthy Volunteers
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114
Pharmacokinetic Characterization of Flotetuzumab in Pediatric Patients With Refractory/Relapsed Acute Myeloid Leukemia
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115
The Effectiveness of Anmarin, an Antimycotic Herbal Drug: Preclinical & Clinical Studies
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116
Addressing Disparities in Clinical Trial Participation: A Comparative Analysis of Cardiovascular & Oncology Studies
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117
Analyzing Drug-Drug Interaction Risk Assessment Strategies for Protein Therapeutics in Inflammatory Bowel Disease: A Literature-Based Evidence Review
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118
Evaluation of Drug-Drug Interaction in Nested Patient Studies
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119
Quantitative Assessment of Drug-Drug Interaction (DDI) Potential of BIIB122 on Oral Contraceptives Using a Physiologically-based Ppharmacokinetic Model
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120
Effect of Herbal Medicines on the Pharmacokinetics of Donepezil
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121
Organic Anion Transporter 3 Mediated Interactions in a Renal Proximal Tubule Epithelial Cellular Model: Effects of Mycophenolate & Prednisolone
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122
A Literature Review on the Performance of Tiny Tract for In Vitro Modeling to Predict Food-Drug & pH-Dependent Drug-Drug Interaction Risks
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123
Assessment of Impact of CYP3A4 Inducers on Investigational Drugs Informed By Clinical Drug-Drug Interaction Data: A Survey of Drugs Approved By FDA
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124
A Drug-Drug Interaction Study to Evaluate the Impact of Coadministration of AZD0780 on Rosuvastatin Exposure in Healthy Participants
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125
Pregabalin-codeine-disease Interactions in Patients With Acute Herpetic or Postherpetic Neuralgia
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126
Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone in Healthy Subjects
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127
Phase I Open Label Study to Evaluate the Effects of Strong CYP1A2 Inhibitor on Savolitinib Pharmacokinetics in Healthy Volunteers
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128
Food & Formulation Effect of a Novel Src Homology Region 2 Domain−containing Protein Tyrosine Phosphatase 2 (SHP2) Allosteric Inhibitor in Combination With Pembrolizumab
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129
Identification of Factors Associated With Vancomycin-Induced Acute Kidney Injury: An Analysis Using a Common Data Model
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130
Clinical Outcomes of Carfilzomib-based Chemotherapy by Relative Dose Intensity in Patients with Relapsed or Refractory Multiple Myeloma
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131
Network Analysis of Sedative Medication Use in a Canadian Cohort of People Living with HIV: Uncovering Potential Sedative Medication Drivers of Frailty States
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132
Strategic Selection of Clinical Trial Core Outcomes Customized to Disease & Drug Therapy: Examples Generated During coreVWD & coreHEM Initiatives
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133
Effect of Probiotics on the Levels of Neuroendocrine Biomarkers – A Systematic Review & Meta-Analysis
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135
Population Kinetic-Pharmacodynamic Modeling of Multiple Lipid Biomarker Responses to Zodasiran in Patients With Mixed Dyslipidemia
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136
Population Pharmacokinetics & Pharmacodynamics of Pegozafermin, a Novel GlycoPEGylated FGF21, in a Phase 2 Study in Severe Hypertriglyceridemia
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137
Application of Lactation Physiologically-based Pharmacokinetic Modeling to Predict Exposure of Select Compounds
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138
Exposure-Response Analyses of Efficacy & Safety of Trastuzumab Deruxtecan to Inform Dosing Recommendation in HER2-mutant Non-Small Cell Lung Cancer
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139
Imaging-based Anti-HIV Antibody Exposure in Anorectal Tissue Is More Closely Linked to Protective Efficacy During Clinical Prevention Trials
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140
Pharmacokinetic-Pharmacodynamic Analysis of Cytokines in First-in-Human Phase 1 Dose Escalation Study of the MALT-1 Inhibitor, SGR-1505, in Healthy Volunteers
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141
A Comparative Analysis of Pharmacokinetics of Oncology Drugs Between Healthy Volunteers & Patients With Cancer
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142
Landscape Analysis of Dose Optimization Approaches in Oncology Investigational New Drug (IND) Submissions in 2023
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143
The Effect of Severe Renal Impairment on ONC201 (Dordaviprone) Pharmacokinetics
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144
Population Pharmacokinetic Model for Tulisokibart in Healthy Participants
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145
Physiologically-based Pharmacokinetic Models of Opioid in Pregnancy, Maternal-Fetal, Pediatrics & Breastfeeding Mothers: A Systematic Literature Review
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146
Optimizing Simvastatin Dosing in Patients Post-gastric Bypass Surgery Using a Population PK/PD Link Approach
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147
Real-World Insights into Drug Dosing Patterns for Commonly Prescribed Drugs During Pregnancy
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148
The Mechanism of Action of an Innovative Respiratory Stimulant, ENA-001
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149
Milvexian Does Not Prolong the QTc Interval: A Thorough QT Study in Healthy Subjects
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150
The Gut-immune-liver Axis in Patients With Alcohol Use Disorder & Clinically Low Serum Zinc Levels
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151
Genome-Wide CpG Methylation Profiling of Leukemia Cells Treated With Curcuminoids
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152
Pharmacoeconomic Analysis of Therapeutic Regimens Used for Treatment of Psoriasis in India
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153
Population Pharmacokinetics/Pharmacodynamics Modeling of INCAGN02385 in Patients With Select Advanced Malignancies
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154
Pharmacokinetics of Sacituzumab Govitecan in Japanese Patients With Advanced Solid Tumors
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155
The Human Metabolism of Lufotrelvir, a Prodrug for the Treatment of SARS-COV2, Investigated By LC+AMS
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156
Comparable Pharmacokinetics of Sacituzumab Govitecan Between Patients With Metastatic Urothelial Cancer & Metastatic Triple-Negative Breast Cancer
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157
Pharmacokinetics & Exposure-Response Analyses of Revumenib Support Dosing in a Broad Population of Patients With Relapsed/Refractory Acute Leukemias
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158
Model-Informed Development of Recombinant
Erwinia
Asparaginase (JZP458) in Patients With Acute Lymphoblastic Leukemia
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159
Pharmacokinetics, Pharmacodynamics & Safety of Budigalimab, An Anti-PD-1 Monoclonal Antibody, in People Living With HIV-1
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160
Modeling Age-related Changes in Kidney Function Using Aminoglycoside Clearance as a Surrogate: Can Body Composition Help?
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161
Comparison of Nicotine Pharmacokinetic & Subjective Profiles of Three Modern Oral Nicotine Products & a Snus Product
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162
Pharmacokinetics of DYP688 in Patients With Metastatic Uveal Melanoma & Other GNAQ/11 Mutant Melanomas
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163
GLP-1-Induced Delays in GI Motility & Their Effects on Co-Administered Drug Absorption: A PBPK Analysis
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164
No Clinically Relevant Effect of Moderate Hepatic Impairment on the Pharmacokinetics of Lirafugratinib
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165
Demographic Composition of New Molecular Entities Approved by the United States FDA Between 2017 & 2023 to Treat Type 2 Diabetes
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166
Fetal & Neonatal Drug Exposure Following Nipocalimab Treatment in Pregnant Women at Risk of EOS-HDFN
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167
Acetaminophen Prescribing & Pharmacokinetic Analysis in Children, Adolescents & Young Adults With Cancer
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