Pharmacometrics & Pharmacokinetics (PMK)

EP-013 - DEVELOPMENT OF POPULATION PHARMACOKINETICS MODEL OF PYRAZINAMIDE AND OPTIMAL DOSE RECOMMENDATION FOR ELDERLY WITH DIABETES MELLITUS IN KOREAN TUBERCULOSIS PATIENTS.

EP-014 - ESTIMATION OF NOVEL BISPECIFIC T-CELL ENGAGER (BiTE®) MOLECULE PHARMACOKINETICS IN CYNOMOLGUS MONKEY FROM STRUCTURALLY-SIMILAR BiTE MOLECULE DATA.

EP-015 - EXPLAINING INTERPATIENT VARIABILITY OF ADALIMUMAB RESPONSE IN CHRONIC PLAQUE PSORIASIS BY PHARMACOKINETIC-PHARMACODYNAMIC MODELLING: RESULTS FROM THE OPTIMAP STUDY.

EP-016 - GATIFLOXACIN EXPOSURE IN THE LESION AS TARGET SITE OF GATIFLOXACIN IN A RABBIT MODEL OF TUBERCULOSIS: COMPARISON WITH THE OUTCOMES FROM THE PHASE III OFLOTUB TRIAL.

EP-017 - MODEL-INFORMED VANCOMYCIN DOSING TO ADDRESS DELAYED RENAL MATURATION IN INFANTS AND YOUNG CHILDREN WITH CONGENITAL HEART DISEASE.

PT-002 - OPTIMIZING CLINICAL TRIALS FOR DUCHENNE MUSCULAR DYSTROPHY USING MULTIVARIATE DISEASE PROGRESSION MODELS THAT BRIDGE A FUNCTIONAL ENDPOINT AND MRI RELAXOGRAPHY OF FIVE LEG MUSCLES.

PT-004 - PROSPECTIVE VALIDATION OF MAXIMUM A POSTERIORI-BAYESIAN ESTIMATION OF TACROLIMUS EXPOSURE IN STABLE KIDNEY TRANSPLANT RECIPIENTS.

PT-006 - A LESION-CENTRIC AND TARGET-SPECIFIC PKPD MODEL OF PYRAZINOIC ACID IN PATIENTS WITH TUBERCULOSIS.

PT-028 - CLINICAL ASSESSMENT OF THE DRUG INTERACTION POTENTIAL OF THE PSYCHOTROPIC NATURAL PRODUCT KRATOM (MITRAGYNA SPECIOSA).

E-004 - EXTRAPOLATION OF EFFICACY OF A DEXTROAMPHETAMINE TRANSDERMAL SYSTEM (d-ATS) FROM PEDIATRIC (PED) TO ADULT POPULATIONS USING PHARMACOKINETIC (PK) MODELING.

EP-034 - POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS OF EDOXABAN IN PEDIATRIC PATIENTS.

EP-035 - MECHANISTIC POPULATION PHARMACOKINETIC MODELLING OF RISDIPLAM FOR EXTRAPOLATION OF EXPOSURE AND CYP3A DRUG-DRUG INTERACTION IN NEONATES WITH SPINAL MUSCULAR ATROPHY.

PI-102 - POST MARKETING COMMITMENT OR REQUIREMENT (PMC/R) FOR RECENT APPROVED DRUG PRODUCTS: SUMMARY FROM CLINICAL PHARMACOLOGY (CP) PERSPECTIVES.

EP-036 - ESTIMATING TARGET ENGAGEMENT USING SINGLE POST-DOSE TIMEPOINT TO SUPPORT FURTHER CLINICAL DEVELOPMENT.

LB-007 - A POPULATION PHARMACOKINETIC/PHARMACODYNAMIC MODEL FOR CARFILZOMIB IN COMBINATION WITH IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA.

LB-009 - IMPACT OF INTRAMUSCULAR INJECTION SITE ON SOTROVIMAB PHARMACOKINETICS.

LB-010 - PEDIATRIC POPULATION PHARMACOKINETIC MODEL DEVELOPMENT FOR ORAL AMOXICILLIN AND CLAVULANIC: LEVERAGING LITERATURE DATA FOR MODEL-INFORMED DRUG EXPOSURE ANALYSIS IN YOUNG CHILDREN.

LB-011 - THE EFFECT OF NASAL CONGESTION ON THE BIOAVAILABILITY OF INTRANASALLY ADMINISTERED EPINEPHRINE IN HEALTHY ADULT SUBJECTS WITH SEASONAL ALLERGIES.

PI-034 - A MULTI-PURPOSE FIRST-IN-HUMAN STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ACT-777991, AN ORAL C-X-C MOTIF CHEMOKINE RECEPTOR 3 (CXCR3) ANTAGONIST.

PI-035 - A POPULATION PHARMACOKINETIC ANALYSIS OF ESCITALOPRAM AND THE EFFECT OF CYP2C19 ON CLEARANCE IN CHILDREN AND ADOLESCENTS.

PI-036 - AN IN SILICO SIMULATION STUDY OF EXTENDED INTERVAL DOSING OF ATEZOLIZUMAB USING POPULATION PHARMACOKINETICS.

PI-037 - AN OPEN-LABEL STUDY TO ASSESS THE EFFECT OF ITRACONAZOLE AND RIFAMPIN ON INCB000928 PHARMACOKINETICS WHEN ADMINISTERED ORALLY IN HEALTHY PARTICIPANTS.

PI-038 - APPLICATION OF MODELING AND SIMULATION TO EXTRAPOLATE THERAPEUTIC BUROSUMAB DOSING REGIMENS FOR SUBJECTS WITH PEDIATRIC TUMOR-INDUCED OSTEOMALCIA.

PI-039 - APPLICATION OF POPULATION PHARMACOKINETIC AND PHARMACODYNAMIC MODELING TO SUPPORT DOSAGE REGIMEN OF FESOTERODINE IN PEDIATRICS WITH NEUROLOGICAL DETRUSOR OVERACTIVITY.

PI-040 - ASSESSING THE GOLDENSEAL-METFORMIN PHARMACOKINETIC INTERACTION IN TYPE 2 DIABETICS.

PI-042 - BUDESONIDE EMBEDDED ALGINATE THIN FILMS SHOW TUNABLE SUSTAINED RELEASE.

PI-044 - CLINICAL DRUG–DRUG INTERACTION STUDIES TO EVALUATE THE EFFECTS OF BEMPEDOIC ACID, A SMALL-MOLECULE INHIBITOR OF ATP CITRATE LYASE, ON THE PHARMACOKINETICS OF CONCOMITANT STATIN THERAPIES.

PI-045 - COMPARATIVE PHARMACOKINETICS BETWEEN DA-2811, A DAPAGLIFLOZIN PRODRUG FORMULATION, AND CONVENTIONAL DAPAGLIFLOZIN TABLET.

PI-046 - COMPARISON OF A COLORIMETRIC ASSAY AND ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY FOR QUANTIFYING PARACETAMOL PLASMA CONCENTRATIONS: DESIGN OF A GERIATRIC PHARMACOKINETICS STUDY.

PI-048 - COMPARISON OF PHARMACOKINETICS AND PHARMACODYNAMICS OF HIP1802 AND NEXIUM®: A RANDOMIZED, OPEN-LABEL, MULTIPLE DOSE, CROSSOVER TRIAL.

PI-049 - COMPARISON OF THE ACID SUPPRESSION EFFECTS BETWEEN LOW-DOSE ESOMEPRAZOLE AND FAMOTIDINE IN HEALTHY SUBJECTS.

PI-052 - CYCLOPHOSPHAMIDE POPULATION PHARMACOKINETICS IN PEDIATRIC PATIENTS UNDERGOING HEMATOPOIETIC STEM CELL TRANSPLANTATION.

PI-055 - DOSE SELECTION FOR BRIGATINIB TO SUPPORT PEDIATRIC DEVELOPMENT.

PI-057 - DOSE–RESPONSE MODEL PREDICTIONS OF THE PHARMACODYNAMIC EFFECT OF BEMPEDOIC ACID, A COMPETITIVE INHIBITOR OF ATP CITRATE LYASE, IN COMBINATION WITH EZETIMIBE AND STATINS.

PI-058 - DRUG-DRUG INTERACTION POTENTIAL OF MAVACAMTEN WITH ORAL CONTRACEPTIVES: RESULTS FROM A CLINICAL PHARMACOKINETIC STUDY.

PI-059 - EARLY CLINICAL PK/PD MODELING AND SIMULATION OF ALPN-303, A POTENT DUAL BAFF/APRIL ANTAGONIST, TO SUPPORT FIRST-IN-DISEASE CLINICAL TRIALS IN SYSTEMIC LUPUS ERYTHEMATOSUS AND OTHER B CELL-RELATED DISEASES.

PI-060 - ECULIZUMAB COMPLEMENT-MEDIATED PK/PD MODEL-INFORMED SIMULATIONS REVEAL THE NEED FOR ALTERNATIVE DOSING REGIMENS DURING MAINTENANCE THERAPY FOR STEM CELL TRANSPLANT-ASSOCIATED THROMBOTIC MICROANGIOPATHY (TA-TMA).

PI-062 - EFFECT OF ACT-539313, A SELECTIVE OREXIN-1 RECEPTOR ANTAGONIST, ON THE CYTOCHROME P450 2C9, 2C19, AND 3A4 SUBSTRATES FLURBIPROFEN, OMEPRAZOLE, AND MIDAZOLAM USING A COCKTAIL APPROACH.

PI-063 - EFFECT OF CYP3A AND CYP2D6 GENOTYPES ON THE PHARMACOKINETICS OF OXYCODONE IN CHILDREN.

PI-064 - EFFECTS OF GLPG3970 ON SULFASALAZINE AND METHOTREXATE PHARMACOKINETICS IN HEALTHY ADULTS: RESULTS OF TWO OPEN-LABEL, PHASE I, DRUG–DRUG INTERACTION STUDIES.

PI-067 - EVALUATION OF CREATININE-BASED RENAL FUNCTION ESTIMATION EQUATIONS BY PHARMACOMETRIC ANALYSIS FOR ANTIBIOTICS.

PI-068 - EXPOSURE-RESPONSE (E-R) OF DUPILUMAB IN PAEDIATRIC PATIENTS WITH MODERATE-TO-SEVERE ASTHMA.

PI-069 - EXPOSURE-RESPONSE MODELING STRATEGIES IN ONCOLOGY: IMPACT OF DOSE REDUCTIONS ON INTERPRETATION OF RESULTS.

PI-070 - EXPOSURE-TARGETED MELPHALAN DOSING INDIVIDULIZATION IN PATIENTS WITH MULTIPLE MYELOMA UNDERGOING AUTOLOGOUS TRANSPLANT.

PI-071 - HOLISTIC INTEGRATION OF POPULATION PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY TO DEFINE RECOMMENDED DOSE FOR EXPANSION OF ATR INHIBITOR, M1774: AN ILLUSTRATION OF MODEL-INFORMED EARLY ONCOLOGY DRUG DEVELOPMENT.

PI-072 - IN VITRO AND IN VIVO POTENTIAL OF ZURANOLONE TO CAUSE CYP-MEDIATED DRUG-DRUG INTERACTIONS.

PI-073 - INTEGRATED MODEL-BASED ANALYSIS UTILIZING CO-EXPRESSED CHECKPOINT INHIBITOR DATA TO INFORM THE RECOMMENDED DOSE FOR EXPANSION (RDE) OF ANTI-TIGIT MAB M6223.

PI-101 - AN OPEN-LABEL SINGLE-DOSE STUDY TO EVALUATE THE PHARMACOKINETICS OF SOTORASIB IN HEALTHY SUBJECTS AND SUBJECTS WITH MODERATE OR SEVERE HEPATIC IMPAIRMENT.

PI-105 - POPULATION PHARMACOKINETICS OF FS-1502, AN HER2 ANTIBODY-DRUG CONJUGATE (ADC), IN PATIENTS WITH HER2 EXPRESSED ADVANCED MALIGNANT SOLID TUMORS.

PII-054 - EFFECT OF COMPLEMENT FACTOR 5A RECEPTOR 1 (C5AR1) ANTAGONIST ACT-1014-6470 ON THE CYTOCHROME P450 2C19 AND 3A4 SUBSTRATES OMEPRAZOLE AND MIDAZOLAM IN A COCKTAIL STUDY IN HEALTHY SUBJECTS.

PII-056 - LENACAPAVIR PHARMACOKINETICS AND DDI POTENTIAL WITH CO-ADMINISTERED ANTIRETROVIRALS IN PEOPLE WITH HIV.

PII-057 - LIMITED DRUG INTERACTION SUPPORTED BY PBPK MODELLING OF ETRUMADENANT (AB928), A NOVEL DUAL ADENOSINE RECEPTOR ANTAGONIST, UNDER COADMINISTRATION WITH A STRONG CYP3A4 AND P-GP INHIBITOR (ITRACONAZOLE) IN HEALTHY PARTICIPANTS.

PII-058 - LOW SENSITIVITY OF TEPOTINIB TO DRUG-DRUG INTERACTIONS WITH CYP3A4 AND P-GP MODULATORS.

PII-060 - METHOTREXATE POPULATION PHARMACOKINETICS IN PATIENTS WITH PRIMARY CNS LYMPHOMA: A SINGLE INSTITUTION RETROSPECTIVE STUDY.

PII-061 - MODEL INFORMED DRUG DEVELOPMENT (MIDD) TO SUPPORT AN ALTERNATIVE NIVOLUMAB DOSE AND SCHEDULE FOR ADVANCED MELANOMA.

PII-062 - MODEL-BASED APPROACH TO SELECT THE DOSE REGIMEN OF GBT021601, A NEXT-GENERATION SICKLE HEMOGLOBIN POLYMERIZATION INHIBITOR, IN HEALTHY VOLUNTEERS AND PATIENTS WITH SICKLE CELL DISEASE.

PII-063 - MODELING AND SIMULATION TO SUPPORT APIXABAN DOSE RECOMMENDATION FOR THROMBOEMBOLISM PREVENTION IN PEDIATRIC SUBJECTS WITH CONGENITAL OR ACQUIRED HEART DISEASE REQUIRING ANTICOAGULATION – SAXOPHONE STUDY.

PII-066 - PHARMACOKINETIC AND PHARMACODYNAMIC CHARACTERISTICS OF PELUBIPROFEN TROMETHAMINE VERSUS PELUBIPROFEN IN HEALTHY SUBJECTS.

PII-067 - PHARMACOKINETIC AND PHARMACODYNAMIC MODELING ANALYSIS OF JPI-547 IN PATIENTS WITH ADVANCED SOLID TUMOR.

PII-069 - PHARMACOKINETIC COMPARISON BETWEEN A FIXED-DOSE COMBINATION OF ATORVASTATIN/OMEGA-3 AND THE CORRESPONDING LOOSE COMBINATION IN HEALTHY KOREAN SUBJECTS.

PII-070 - PHARMACOKINETIC/PHARMACODYNAMIC ANALYSIS OF APIXABAN TO DETERMINE DOSING REGIMENS FOR PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA OR LYMPHOBLASTIC LYMPHOMA TREATED WITH ASPARAGINASE: ANALYSIS FROM THE PREVAPIX STUDY.

PII-071 - PHARMACOKINETICS (PK) OF HZN-825, A SMALL MOLECULE SELECTIVE ANTAGONIST OF LPAR1, AND THE EFFECT OF FOOD IN HEALTHY ADULT SUBJECTS.

PII-072 - PHARMACOKINETICS AND PHARMACODYNAMICS MODELING OF ACETAMINOPHEN AND IBUPROFEN TO EVALUATE THE TIME TO PATENT DUCTUS ARTERIOSUS CLOSURE IN PRETERM NEONATES.

PII-075 - PHARMACOMETRICS (PMX) APPROACH TO SUPPORT PEDIATRIC DOSING FOR THE PAN-PI3K INHIBITOR COPANLISIB IN CHILDREN AND ADOLESCENTS WITH RELAPSED/REFRACTORY SOLID TUMORS.

PII-076 - POPULATION PHARMACOKINETIC (PK)-PHARMACODYNAMIC (PD) MODELING OF VESATOLIMOD, A TLR7 AGONIST IN DEVELOPMENT FOR HIV CURE.

PII-078 - POPULATION PHARMACOKINETIC MODELING OF CLOFAZIMINE: CHARACTERIZING THE IMPACT OF CRYPTOSPORIDIOSIS-ASSOCIATED DIARRHEA ON ORAL DRUG PHARMACOKINETICS IN HIV-INFECTED ADULTS.

PII-079 - POPULATION PHARMACOKINETIC MODELING OF EVEROLIMUS AND INDIVIDUALIZED DOSING DEPENDING ON PROMISING COVARIATES IN LIVER TRANSPLANT RECIPIENTS.

PII-081 - POPULATION PHARMACOKINETICS (PK) OF ETHAMBUTOL IN TUBERCULOSIS PATIENTS – TUBERCULOSIS TRIALS CONSORTIUM (TBTC) STUDY A5349/S31.

PII-082 - POPULATION PHARMACOKINETICS (POPPK) OF SACITUZUMAB GOVITECAN (SG) IN PATIENTS (PTS) WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER (MBC) OR OTHER SOLID TUMORS.

PII-083 - POPULATION PHARMACOKINETICS OF GS-3583 IN HEALTHY VOLUNTEERS AND PATIENTS WITH ADVANCED SOLID TUMORS.

PII-084 - POPULATION PHARMACOKINETICS OF MYCOPHENOLATE MOFETIL IN PEDIATRIC ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION PATIENTS.

PII-087 - THE EFFECT OF FOOD ON T3 AND T4 BIOAVAILABILITY AND THE DOSE PROPORTIONALITY OF ARMOUR THYROID.

PII-088 - THE EFFECT OF UGT INHIBITION ON THE PHARMACOKINETICS OF ECOPIPAM AND ITS METABOLITES.

PII-089 - THE EFFECTS OF CYP3A INDUCTION AND INHIBITION ON ZURANOLONE PHARMACOKINETICS IN HEALTHY ADULTS.

PII-091 - TRANSLATIONAL TOOL FOR PREDICTING THE EARLY BACTERICIDAL ACTIVITY OF SUTEZOLID FOR THE TREATMENT OF TUBERCULOSIS.

PII-093 - ZURANOLONE, A NOVEL GABAA POSITIVE ALLOSTERIC MODULATOR, DOES NOT PROLONG THE QT INTERVAL.

PWII-001 - MODEL-BASED APPROACH TO SELECT THE DOSE REGIMEN OF GBT021601, A NEXT-GENERATION SICKLE HEMOGLOBIN POLYMERIZATION INHIBITOR, IN HEALTHY VOLUNTEERS AND PATIENTS WITH SICKLE CELL DISEASE.

PWIII-004 - EFFECT OF CYP3A AND CYP2D6 GENOTYPES ON THE PHARMACOKINETICS OF OXYCODONE IN CHILDREN.