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A
PII-035
A BIOEQUIVALENCE AND FOOD EFFECT CLINICAL STUDY OF ZOLIFLODACIN, FIRST-IN-CLASS ORAL ANTIBIOTIC, BEING DEVELOPED FOR THE TREATMENT OF UNCOMPLICATED GONORRHEA
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PII-210
A BIOMARKER-FOCUSED QSP MODEL OF COMPLEMENT ALTERNATIVE AND TERMINAL PATHWAYS TO EVALUATE POTENTIAL TARGETS FOR THERAPEUTIC IMPACT IN COMPLEMENT-ASSOCIATED DISEASES: PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AS A CASE STUDY.
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PII-041
A CHEMICAL BIOLOGY STRATEGY FOR PREDICTING OATP1B-TYPE TRANSPORTER-MEDIATED DRUG-DRUG INTERACTION (DDI) LIABILITIES
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TIP-001
A CLINICAL STUDY OF NOVEL BCRP AND ESTABLISHED OATP BIOMARKERS FOR PREDICTING DRUG-DRUG INTERACTIONS.
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PII-179
A COMPUTATIONAL TOOL TO OPTIMIZE CLINICAL TRIAL DESIGN FOR DUCHENNE MUSCULAR DYSTROPHY: A PRACTICAL GUIDE AND CASE STUDIES.
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LB-001
A GENERIC TACROLIMUS CAPSULE SHOWN NOT TO BE BIOEQUIVALENT TO THE BRAND TACROLIMUS CAPSULE IN A POST-APPROVAL PHARMACOKINETIC BIOEQUIVALENCE STUDY IN HEALTHY SUBJECTS
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PT-006
A GENOME-WIDE DNA METHYLATION ANALYSIS REVEALS DIFFERENT METHYLATION PATTERNS AND MECHANISTIC CLUES OF MEDICATION-RELATED OSTEONECROSIS OF THE JAW.
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OAII-003
A LONGITUDINAL HBA1C MODEL IN PATIENTS WITH TYPE 2 DIABETES ELUCIDATES THE ROLE OF CODING VARIANT IN GLUCOSE TRANSPORTER GENE, SLC2A2, ON GLYCEMIC RESPONSE TO METFORMIN.
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PT-003
A LONGITUDINAL HBA1C MODEL IN PATIENTS WITH TYPE 2 DIABETES ELUCIDATES THE ROLE OF CODING VARIANT IN GLUCOSE TRANSPORTER GENE, SLC2A2, ON GLYCEMIC RESPONSE TO METFORMIN.
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LB-002
A MINIMAL PHYSIOLOGICALLY BASED PHARMACOKINETIC (MPBPK) MODEL TO CHARACTERIZE PSA07 BACTERIOPHAGE (PHAGE) PHARMACOKINETICS (PK) FOLLOWING INTRAVENOUS (IV) ADMINISTRATION IN MICE FOR TREATMENT OF P. AERUGINOSA (PSA) INFECTIONS
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PII-005
A NOVEL ENDOTYPE OF ADULT ASTHMA SUGGESTED BY PLASMA METABOLITE PROFILING OF THE COHORT FOR REALITY AND EVOLUTION OF ADULT ASTHMA IN KOREA (COREA)
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LB-003
A NOVEL MECHANISTIC PHYSIOLOGICALLY BASED PHARMACOKINETIC-PHARMACODYNAMIC (PBPK-PD) MODEL TO ASSESS DRUG-DRUG INTERACTION (DDI) RISKS FOR ACID REDUCING AGENTS (ARA).
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LB-004
A NOVEL PHYSIOLOGICALLY BASED OCULAR PHARMACOKINETIC MODEL INCORPORATING ACCURATE DYNAMICS OF THE ANTERIOR EYE
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PII-090
A PHARMACOKINETIC AND ENZYME TURNOVER MODEL PREDICTS MAJOR ROLES FOR CYP2B6 GENOTYPES ON THE MAGNITUDE OF EFAVIREZ AUTOINDUCTION OF METABOLISM AND CLEARNCE IN HEALTHY VOLUNTEERS
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LB-005
A PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF AMX0035 IN PARTICIPANTS WITH AMYOTROPHIC LATERAL SCLEROSIS
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PII-091
A PHASE 1 OPEN-LABEL, FIXED-SEQUENCE 3-PERIOD STUDY TO EVALUATE PHARMACOKINETIC INTERACTIONS BETWEEN FIMASARTAN AND INDAPAMIDE IN HEALTHY VOLUNTEERS
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PII-092
A PHASE 1 SINGLE ASCENDING DOSE (SAD) STUDY OF FOOD EFFECTS AND DRUG-DRUG INTERACTION (DDI) EFFECTS OF PH-MODIFYING AGENTS ON INCB099318 PHARMACOKINETICS (PK), A PROGRAMMED DEATH-LIGAND 1 (PD-L1) INHIBITOR, IN HEALTHY PARTICIPANTS
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PII-194
A PHASE 1 STUDY COMPARING PHARMACOKINETICS OF RIMEGEPANT 25 MG ORALLY DISINTEGRATING TABLET (ODT) PEDIATRIC FORMULATION WITH RIMEGEPANT 75 MG ODT ADULT FORMULATION, WHEN ADMINISTERED AT A SINGLE DOSE OF 75 MG UNDER FASTING CONDITIONS
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PII-195
A PHASE 1 STUDY OF THE PHARMACOKINETICS OF ADAGRASIB IN SUBJECTS WITH MILD, MODERATE, OR SEVERE HEPATIC IMPAIRMENT COMPARED TO SUBJECTS WITH NORMAL HEPATIC FUNCTION.
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PII-196
A PHASE 1 STUDY OF THE PHARMACOKINETICS OF ADAGRASIB IN SUBJECTS WITH MILD, MODERATE, OR SEVERE RENAL IMPAIRMENT COMPARED TO SUBJECTS WITH NORMAL RENAL FUNCTION.
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PII-093
A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS OF A SINGLE DOSE OF DAZODALIBEP IN HEALTHY JAPANESE AND CAUCASIAN PARTICIPANTS.
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PII-094
A PHASE 1, SINGLE ASCENDING DOSE (SAD) STUDY OF FOOD EFFECT AND DRUG-DRUG INTERACTION (DDI) EFFECTS OF PH-MODIFYING AGENTS ON INCB099280 PHARMACOKINETICS (PK), A PROGRAMMED DEATH-LIGAND 1 (PD-L1) INHIBITOR, IN HEALTHY PARTICIPANTS
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PII-095
A POPULATION PHARMACOKINETIC (PK) MODEL OF MILVEXIAN, A SMALL MOLECULE FACTOR XIA INHIBITOR, IN HEALTHY VOLUNTEERS.
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PII-185
A QUANTITATIVE MODELING APPROACH TO PREDICT AVAILABILITY OF GENERIC ORPHAN DRUG PRODUCTS.
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PII-211
A QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL FOR PRECLINICAL TO CLINICAL TRANSLATION OF ANTIBODY-DRUG CONJUGATE (ADC) EFFICACY AND THROMBOCYTOPENIA.
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PII-212
A QUANTITATIVE SYSTEMS PHARMACOLOGY (QSP) MODEL FOR PREDICTING EFFICACY FOR A COMBINATION OF AN ANTIBODY DRUG CONJUGATE (ADC) AND A CHECKPOINT INHIBITOR (CPI) IN PHASE II/III CLINICAL TRIALS
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PII-006
A SNAPSHOT OF PHARMACODYNAMIC BIOMARKERS BIOANALYSIS IN 16 BLAS APPROVED FOR NEUROLOGY INDICATIONS.
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PII-186
A SURVEY ON RECOMMENDATION OF FOOD CONDITIONS IN BIOEQUIVALENCE STUDIES WITH PHARMACOKINETIC ENDPOINTS FOR GENERIC ORAL ANTINEOPLASTIC DRUG DEVELOPMENT.
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PWI-002
A TRANSLATIONAL MODELING AND SIMULATION APPROACH TO INFORM FIRST-IN-HUMAN DOSE SELECTION FOR AN SIRNA TARGETING COMPLEMENT C3.
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PII-096
A TRANSLATIONAL MODELING AND SIMULATION APPROACH TO INFORM FIRST-IN-HUMAN DOSE SELECTION FOR AN SIRNA TARGETING COMPLEMENT C3.
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PII-072
A VALUE PROPOSITION FOR USING PHARMACOGENETIC TESTING IN MENTAL HEALTH CARE
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PII-045
ACETYLATION-DEPENDENT REGULATION OF NUCLEAR PD-L1 IS CRITICAL TO SISTER CHROMATID COHESION IN TRIPLE NEGATIVE BREAST CANCER
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CT-009
ADDRESSING THE RACIAL DISPARITY OF ANGIOTENSIN INHIBITOR ASSOCIATED REDUCTION IN HFREF HOSPITALIZATIONS: DISTINGUISHING BETWEEN RACE AND ANCESTRY
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PII-073
ADDRESSING THE RACIAL DISPARITY OF ANGIOTENSIN INHIBITOR ASSOCIATED REDUCTION IN HFREF HOSPITALIZATIONS: DISTINGUISHING BETWEEN RACE AND ANCESTRY
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CT-001
AGE-APPROPRIATE DOSING FOR DEXAMETHASONE TO PREVENT POST-EXTUBATION STRIDOR: A PEDIATRIC PBPK MODELING APPROACH
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PII-160
AGE-APPROPRIATE DOSING FOR DEXAMETHASONE TO PREVENT POST-EXTUBATION STRIDOR: A PEDIATRIC PBPK MODELING APPROACH
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PT-010
ALCOHOL USE DISORDER PHARMACOGENOMICS: ROLE OF FNDC4 IN HUMAN NEURONAL FUNCTION.
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OAII-002
ALCOHOL USE DISORDER PHARMACOGENOMICS: ROLE OF FNDC4 IN HUMAN NEURONAL FUNCTION.
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PII-046
AN EVALUATION OF THE DRUG INTERACTION POTENTIAL OF ENCORAFENIB IN COMBINATION WITH BINIMETINIB USING THE INJE COCKTAIL IN PATIENTS WITH BRAF V600-MUTANT UNRESECTABLE OR METASTATIC MELANOMA OR OTHER ADVANCED SOLID TUMORS
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PII-097
AN INTEGRATED ASSESSMENT OF THE AME PROPERTIES OF SELTOREXANT UTILIZING PRECLINICAL IN VITRO, IN VIVO, AND HUMAN ADME DATA.
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PII-047
AN OPEN-LABEL BIOEQUIVALENCE STUDY IN HEALTHY VOLUNTEERS TO COMPARE THE PHARMACOKINETICS OF TWO DIFFERENT TABLET STRENGTHS OF SOTORASIB IN THE FED AND FASTED STATE
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PII-043
ANTIDEPRESSANT EXPOSURE IN THE ADOLESCENT BRAIN: FLUOXETINE AND PHARMACOGENETIC INFLUENCES ON BRAIN DISPOSITION
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PII-048
APPARENT FCRN DYSFUNCTION IN CANCER CACHEXIA DECREASES EXTRAVASCULAR IMMUNOGLOBULIN G ABSORPTION.
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AI-001
APPLICATION OF GAUSSIAN PROCESS MODEL IN LONGITUDINAL PHARMACOKINETIC/PHARMACODYNAMIC DATA AND COMPARISON WITH NATURAL LANGUAGE PROCESSING MODELS
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PII-098
APPLICATION OF GAUSSIAN PROCESS MODEL IN LONGITUDINAL PHARMACOKINETIC/PHARMACODYNAMIC DATA AND COMPARISON WITH NATURAL LANGUAGE PROCESSING MODELS
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AI-002
APPLICATION OF MACHINE LEARNING COMBINED WITH POPPK AND QSP MODELS FOR ADVERSE EVENTS RISK PREDICTION OF A CD19-TARGETING BISPECIFIC THERAPY
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PT-007
APPLICATION OF MACHINE LEARNING COMBINED WITH POPPK AND QSP MODELS FOR ADVERSE EVENTS RISK PREDICTION OF A CD19-TARGETING BISPECIFIC THERAPY
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CT-006
APPLICATION OF PBPK TO ASSESS THE IMPACT OF UGT1A1 GENOTYPE ON DOLUTEGRAVIR EXPOSURE IN PREGNANT WOMEN AND FETUSES
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PII-161
APPLICATION OF PBPK TO ASSESS THE IMPACT OF UGT1A1 GENOTYPE ON DOLUTEGRAVIR EXPOSURE IN PREGNANT WOMEN AND FETUSES
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PII-162
APPLICATION OF PBPK TO SUPPLEMENT CLINICAL DATA AND INVESTIGATE THE IMPACT OF UGT1A1 PHENOTYPE ON DOLUTEGRAVIR EXPOSURE IN AFRICAN BREASTFED INFANTS
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CT-007
APPLICATION OF PBPK TO SUPPLEMENT CLINICAL DATA AND INVESTIGATE THE IMPACT OF UGT1A1 PHENOTYPE ON DOLUTEGRAVIR EXPOSURE IN AFRICAN BREASTFED INFANTS
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PII-163
APPLICATION OF PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING TO SUPPORT BIOEQUIVALENCE EVALUATION OF MESALAMINE DELAYED RELEASE TABLETS
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PII-001
APPROVED THERAPEUTIC PROTEINS WITH CHALLENGES IN CLINICAL ENDPOINTS EVALUATION WHERE PHARMACODYNAMIC BIOMARKERS MAY IMPROVE EFFICIENCY OF BIOSIMILAR DEVELOPMENT
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LB-006
ARTERIAL STIFFNESS AND SYSTEMIC VASCULAR CORRELATES OF BRAIN AMYLOIDOSIS AND PRECLINICAL AD
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PII-025
ASCENDING DOSE IN VIVO QT STUDIES HAVE THE SENSITIVITY TO DETECT QT INTERVAL CHANGES THAT ARE SUFFICIENT TO SUPPORT A CLINICAL QT WAIVER: ASSESSMENT OF QT/QTC INTERVAL CHANGES USING AN ESCALATING DOSE DESIGN IN TELEMETERED BEAGLE DOGS.
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PII-164
ASSESSING CYTOCHROME P450 DRUG INTERACTION RISK FOR ONC201 USING PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING
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LB-007
ASSESSING POTENTIAL DRUG-DRUG INTERACTIONS INVOLVING Δ-9-TETRAHYDROCANNABINOL AND CANNABIDIOL IN HEALTHY ADULTS USING PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELS
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PII-187
ASSESSMENT OF MALE INFERTILITY RISKS TO SUPPORT PRODUCT-SPECIFIC GUIDANCE DEVELOPMENT FOR GENERIC ORAL PRODUCTS.
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PII-165
AUTOMATED QUALIFICATION FRAMEWORK FOR PHYSIOLOGICALLY-BASED QUANTITATIVE SYSTEMS PHARMACOLOGY MODELING
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PII-099
AUTOSOMAL DOMINANT TUBULOINTERSTITIAL KIDNEY DISEASE: JOINT LONGITUDINAL-SURVIVAL DISEASE PROGRESSION MODELS.
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