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Poster Schedule
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Poster Schedule
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Sun, Sep 10
Mon, Sep 11
Poster Schedule
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Sunday, September 10, 2023
5:00 PM - 7:00 PM
PT
001: Genomic Risk Factors of Vincristine-Induced Peripheral Neuropathy
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5:00 PM - 7:00 PM
PT
002: Model-based Investigation on Allometric Scaling in Pediatric PK: The Effects of Sample Size, Sampling Scheme & Age Range
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5:00 PM - 7:00 PM
PT
003: Is the Current Dosing Regimen of Ropivacaine Administered through Erector Spinae Plane Blocks Safe?
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5:00 PM - 7:00 PM
PT
004: Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry for the Simultaneous Detection of Conjugated Metabolites of Indoxyl & p-Cresol for Toxicokinetic Investigations
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5:00 PM - 7:00 PM
PT
005: Investigating Tacrolimus Population Pharmacokinetics in Adult Hispanic Renal Transplant Recipients
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5:00 PM - 7:00 PM
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006: Infant & Adult VRC07-523LS Population Pharmacokinetic Modeling to Predict HIV Prevention in Breastfed Infants
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5:00 PM - 7:00 PM
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007: Drug & Dietary Supplement Exposures During Pregnancy & Lactation in the United States Between 2011-2022
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5:00 PM - 7:00 PM
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008: Is There a Need for a Dedicated Pharmacokinetic Trial for a Drug in Obese Populations? A Drug Prioritization Decision Tree Framework
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5:00 PM - 7:00 PM
PT
009: A Combined Ex Vivo & Physiologically-based Pharmacokinetic Approach to Determine Fentanyl Dosing in Children on Continuous Renal Replacement Therapy
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5:00 PM - 7:00 PM
PT
010: Development of a Mechanistic-Physiologically Based Pharmacokinetic Platform Model to Guide Adult & Pediatric Dosing for Bispecific T Cell Engagers through Intravenous & Subcutaneous Administration
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5:00 PM - 7:00 PM
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011: Analysis of Supervised Machine Learning Algorithms & Computational Validation of the Single Nucleotide Polymorphisms of Antioxidant Enzymes & Oxidative Stress Biomarkers in Preterm Neonates
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5:00 PM - 7:00 PM
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012: Pharmacogenomics of L-Asparaginase-induced Pancreatitis in Pediatric Patients With Acute Lymphoblastic Leukemia
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5:00 PM - 7:00 PM
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013: Impacts of Bio-Batch Adequacy on Bioequivalence Assessment of Generic Drug Product Applications
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5:00 PM - 7:00 PM
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014: Impact of Solubility & Dissolution Performance on Bioequivalence Recommendations for Immediate-Release Locally Acting Gastrointestinal Drug Products
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5:00 PM - 7:00 PM
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015: Biosimilar Uptake & Cost Savings Analysis Before & After Implementation of a Pharmacist-driven Substitution Program Within a National Community Oncology Network: One Year Follow-up
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5:00 PM - 7:00 PM
PT
016: Oral Human Abuse Potential of PF614: A Novel Trypsin Activated Abuse Protected (TAAP) Extended-Release Oxycodone Prodrug
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5:00 PM - 7:00 PM
PT
017: Intranasal Human Abuse Potential of PF614: A Novel Trypsin Activated Abuse Protected (TAAP) Extended-Release Oxycodone Prodrug
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5:00 PM - 7:00 PM
PT
018: A Novel Auto-Injector Design to Maintain Investigator Blinding in Randomised Controlled Trials
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5:00 PM - 7:00 PM
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019: FDA Trends for Accelerated Drug Approvals in Oncology Indications
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5:00 PM - 7:00 PM
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020: A Science-based Approach for Recommendation of Antagonist Blockade in the Bioequivalence Studies of Opioid Drug Products
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5:00 PM - 7:00 PM
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021: Efficacy of Bulevirtide as Monotherapy for Chronic Hepatitis D (CHD): Week 48 Results from an Integrated Analysis
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5:00 PM - 7:00 PM
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022: Pharmacokinetics of a Fixed-dose Combination of Dapagliflozin 10 mg & Sitagliptin 100 mg for the Treatment of Type 2 Diabetes Mellitus
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5:00 PM - 7:00 PM
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025: Pediatric Drug Development Programs for Locally Acting Drug-Device Combination Products
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5:00 PM - 7:00 PM
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026: Differential Induction Effects of Prednisone & Prednisolone on Mycophenolic Acid Intrinsic Clearance
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5:00 PM - 7:00 PM
PT
027: Application of Modeling & Simulation to Quantitatively Assess Ulotaront Metabolism & the Effect of a CYP450 Inhibitor in Healthy Subjects
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5:00 PM - 7:00 PM
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028: A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects
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5:00 PM - 7:00 PM
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029: In Vitro & In Vivo Assessment on Endogenous Biomarkers for Studying Renal Transporter (OCT2, MATE1/2-K) Mediated Drug Interaction & Disease Impact Consideration in Novel Endogenous Biomarker, N1-Methyladenosine: A Systematic Review
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5:00 PM - 7:00 PM
PT
030: Drug-Drug Interaction of Celecoxib With Navitoclax in Subjects With Myeloproliferative Neoplasms (MPN)
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5:00 PM - 7:00 PM
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031: Pharmacokinetic Drug Interaction Between Nipocalimab & Fremanezumab in Healthy Subjects
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5:00 PM - 7:00 PM
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032: Effect of Carbamazepine, a CYP29C & 3A4 Inducer, on the Pharmacokinetics of Erdafitinib (Balversa®): A Phase I Drug-Drug Interaction Study in Healthy Adult Participants
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5:00 PM - 7:00 PM
PT
033: Improving the Working Models for Drug-Drug Interactions: Impact on Preclinical & Clinical Drug Development
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5:00 PM - 7:00 PM
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034: Application of Hybrid Pharmacometric/Machine-Learning Approach to Inform Moxifloxacin Therapeutic Drug Monitoring in Children
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5:00 PM - 7:00 PM
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035: Adoption of Patient Reported Outcomes in Early Clinical Trials for Oncology Drugs: Challenges & Opportunities
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5:00 PM - 7:00 PM
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036: Clinical Validation of Two Volumetric Absorptive Microsampling Devices to Support Home-based Therapeutic Drug Monitoring of Immunosuppression in Kidney Transplantation
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5:00 PM - 7:00 PM
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037: Understanding Methotrexate Concentrations & Associated Toxicities to Guide Supportive Care in Patients With Osteosarcoma
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5:00 PM - 7:00 PM
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038: Development & Qualification of a Population Model of Gene Therapy for the Treatment of Hemophilia A & Comparison With FVIII Therapies
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5:00 PM - 7:00 PM
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039: Retrospective Time to Dose Modification Evaluation of Apalutamide
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5:00 PM - 7:00 PM
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040: An Interactive Approach for Evaluation of Monoclonal Antibody Dosing in Light of Rapidly Evolving SARS-CoV-2 Variants
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5:00 PM - 7:00 PM
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041: Predicting Clinical PK/PD & Impacts of Organ Impairment to Support Clinical Development of siRNA-based Therapeutics Using a Mechanistic Physiologically Based Pharmacokinetic & Pharmacodynamic (PBPK-PD) Platform Model
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5:00 PM - 7:00 PM
PT
042: Characterizing the Effect of Recombinant Human Hyaluronidase on Subcutaneous Pharmacokinetics of Drugs
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5:00 PM - 7:00 PM
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043: Semi-Mechanistic Model of Tumor Lysis Syndrome in Chronic Lymphocytic Leukemia Patients
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5:00 PM - 7:00 PM
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044: The Role of Exposure-Response Analyses in Determination of Recommended Dose for Expansion in a Phase I/Ib Study of NIZ985 Alone & in Combination With Spartalizumab in Cancer Patients
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5:00 PM - 7:00 PM
PT
045: Applications of Physiologically-based Pharmacokinetic Modeling & Model Based Meta-analysis in Hormonal Contraceptive Breakthrough Bleedings Analysis
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5:00 PM - 7:00 PM
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046: Model-Based Meta-Analyses to Compare Inhaled Fluticasone Furoate & Vilanterol Systemic Exposures in Japanese & Non-Japanese Pediatric Population With Asthma
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5:00 PM - 7:00 PM
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047: Population Pharmacokinetic Modeling to Establish Exposure Equivalence Between Two Formulations of Albuterol Dry Powder Inhaler
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5:00 PM - 7:00 PM
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048: Population Modeling Analyses of Sotatercept Pharmacokinetics, Safety & Efficacy in Healthy Participants & Patients With Pulmonary Arterial Hypertension
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5:00 PM - 7:00 PM
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051: Drug Discovery of PPAR (Peroxisome Proliferator Activated Receptor) Agonists as Promising Treatment for Alzheimer's Disease
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5:00 PM - 7:00 PM
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055: Population Pharmacokinetic Modeling to Assess the Impacts of Clinical Variables on Mycophenolate Total Body Clearance in Pediatric Kidney Transplant Recipients
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5:00 PM - 7:00 PM
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056: Population Pharmacokinetic Analysis of Tucatinib in Healthy Subjects & Subjects With HER2+ Metastatic Breast Cancer or Metastatic Colorectal Cancer
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5:00 PM - 7:00 PM
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057: Population Pharmacokinetic Model Development of Autologous CD30.CAR-T Cells in Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) Patients
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5:00 PM - 7:00 PM
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058: Population Pharmacokinetic Modelling to Predict Trofinetide Exposure & Exposure-Response Safety Analyses in Girls With Rett Syndrome Aged 2–4 Years
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5:00 PM - 7:00 PM
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059: Pharmacokinetics & Immunogenicity of Combination Therapy of Guselkumab & Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis
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5:00 PM - 7:00 PM
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060: A Phase 1 Study of 5-HT2C Superagonist LP352 Shows Robust Brain Penetration, a Strong Correlation Between Plasma & CSF Pharmacokinetics & QEEG Changes Reflecting Receptor Engagement
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5:00 PM - 7:00 PM
PT
061: Cefazolin Removal Via Pediatric Continuous Renal Replacement Therapy: An Ex-vivo Analysis
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5:00 PM - 7:00 PM
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062: The MILK Study: Investigating Pharmacokinetics of Low-calorie Sweeteners in Mother Infant Dyads
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5:00 PM - 7:00 PM
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063: The Effect of Administering Dordaviprone as Capsule Contents Mixed With Applesauce or Dissolved in Gatorade on the Pharmacokinetics of Dordaviprone in Healthy Adult Participants
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5:00 PM - 7:00 PM
PT
064: A Phase 1b, Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics & Safety of Vadadustat in Hemodialysis Patients With Anemia Associated With Chronic Kidney Disease
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5:00 PM - 7:00 PM
PT
065: Pharmacokinetics of Subcutaneous Itepekimab Injection With an Autoinjector Device or Prefilled Syringe
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5:00 PM - 7:00 PM
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066: Population Pharmacokinetics & Exposure-Response Analysis of Durvalumab With Gemcitabine & Cisplatin in Patients With Advanced Biliary Tract Cancer
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5:00 PM - 7:00 PM
PT
067: Absolute Oral Bioavailability of Milvexian Spray-dried Dispersion Formulation Under Fasted & Fed Conditions in Healthy Adult Participants Using an Intravenous Microtracer Approach
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5:00 PM - 7:00 PM
PT
068: Anakinra Removal by Continuous Renal Replacement Therapy: An Ex-vivo Analysis
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5:00 PM - 7:00 PM
PT
069: Population Pharmacokinetic Model of Delta-9-Tetrahydrocannabinol (THC) & Metabolites in Healthy Adults Following Single Oral Dose
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5:00 PM - 7:00 PM
PT
070: A Phase I Study of the Absorption, Metabolism & Excretion Following a Single Oral Dose of [14C]-Adagrasib in Healthy Male Subjects
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5:00 PM - 7:00 PM
PT
071: Pharmacokinetics, Safety & Tolerability of HZN-825, a LPAR-1 Antagonist, Following Single & Multiple Doses in Healthy Japanese Subjects
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5:00 PM - 7:00 PM
PT
072: Population Pharmacokinetic Modelling to Confirm Weight-Based Banded Dosing & Exposure-Response Efficacy Analyses to Support Trofinetide Treatment in Rett Syndrome
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5:00 PM - 7:00 PM
PT
073: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Fixed-Sequence Study to Assess the Relative Bioavailability & Safety of Low-Sodium Oxybate Between Japanese & Non-Asian Participants
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5:00 PM - 7:00 PM
PT
074: The Effect of Itraconazole, a Strong CYP3A4 Inhibitor, on the Pharmacokinetics of Dordaviprone in Healthy Adult Participants
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5:00 PM - 7:00 PM
PT
075: Precision Dosing in Critically Ill Patients: A Voriconazole Case Study
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5:00 PM - 7:00 PM
PT
076: Pharmacokinetics, Metabolism, Excretion & Mass Balance of 14C-HZN-825, a LPAR-1 Antagonist, in Healthy Male Subjects
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5:00 PM - 7:00 PM
PT
077: TABLET: Relative Bioavailability & Bioequivalence Study of Niraparib Tablets & Capsules in Patients With Advanced Solid Tumors
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5:00 PM - 7:00 PM
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078: Survey of Bioequivalence Data of Abbreviated New Drug Applications of Narrow Therapeutic Index Drug Products
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5:00 PM - 7:00 PM
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079: A Review of Immunogenicity & Its Effect on Efficacy & Safety of Biologics as Reported on the Prescribing Label to Support Strategic Thinking & Planning Labeling Communications
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5:00 PM - 7:00 PM
PT
080: Improving Administration Method Consistency of Product-Specific Guidances for Chewable Tablets & Tablet Products With Chewing in Labeling
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5:00 PM - 7:00 PM
PT
081: Country Contribution of Investigators to Pivotal Clinical Trials & their Primary Publications of New Drugs Approved by the US Food & Drug Administration
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5:00 PM - 7:00 PM
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082: Swallowability of Solid Oral Drug Products in Regulatory Submissions: Patient-Specific Features, Product Physical Attributes & Clinical Swallowability Study Designs
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5:00 PM - 7:00 PM
PT
083: Pharmacokinetics & Safety of Navitoclax in Hepatic Impairment
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5:00 PM - 7:00 PM
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084: Effect of Hepatic Impairment on Single Dose Pharmacokinetics (PK) of Lazertinib
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5:00 PM - 7:00 PM
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085: Vancomycin Associated Nephrotoxicity & Clinical Outcomes Assessment in Geriatric Empiric Dosing Strategies (VANCO-AGED)
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5:00 PM - 7:00 PM
PT
086: Probing Gastric Emptying & Drug Metabolism Changes in Patients With Obesity Undergoing Weight-Loss Using a Cocktail Containing Acetaminophen, Caffeine & Omeprazole
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5:00 PM - 7:00 PM
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087: Simulating (R)-omeprazole & (S)-omeprazole Pharmacokinetics in Obese & Post-bariatric Surgery Patients by Physiologically based Pharmacokinetic Modeling
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5:00 PM - 7:00 PM
PT
088: Development, Verification & Application of Physiologically-based Pharmacokinetic Model to Evaluate the CYP3A4-mediated Drug-Drug Interactions Potential of Omaveloxolone
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5:00 PM - 7:00 PM
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089: The Utilization of Pharmacokinetic/Pharmacodynamic (PK/PD) Model-based Analysis of Myelosuppression in Clinical Trials: Analysis from Adavosertib Clinical Studies
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5:00 PM - 7:00 PM
PT
090: Flushing Out Translational Excretion Data: How Well Do Nonclinical ADME Results Predict Clinical Findings?
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