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Concentration–Response Modeling of ECG Data From Early‐Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk — Experience From the Development Program of Lemborexant

Journal of clinical pharmacology, 2017-01, Vol.57 (1), p.96-104

2017

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Population pharmacokinetic‐pharmacodynamic analyses of amyloid positron emission tomography and plasma biomarkers for lecanemab in subjects with early Alzheimer's disease

CPT: pharmacometrics and systems pharmacology, 2022-12, Vol.11 (12), p.1578-1591

2022

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Population pharmacokinetic‐pharmacodynamic modeling of serum biomarkers as predictors of tumor dynamics following lenvatinib treatment in patients with radioiodine‐refractory differentiated thyroid cancer (RR‐DTC)

CPT: pharmacometrics and systems pharmacology, 2024-06, Vol.13 (6), p.954-969

2024

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A combined physiologically‐based pharmacokinetic and quantitative systems pharmacology model for modeling amyloid aggregation in Alzheimer's disease

CPT: pharmacometrics and systems pharmacology, 2023-04, Vol.12 (4), p.444-461

2023

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Pharmacokinetics of Perampanel in Healthy Korean, White, and Japanese Adult Subjects

Clinical pharmacology in drug development, 2018-08, Vol.7 (6), p.613-620

2018

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Exposure-Response Modeling to Describe Change in Brain Amyloid Following Lecanemab Administration in Patients with Early Alzheimer’s Disease (P9-9.011)

Neurology, 2024-04, Vol.102 (17_supplement_1)

2024

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A Single- and Multiple-Dose Pharmacokinetic Study of Oral Perampanel in Healthy Chinese Subjects

Clinical drug investigation, 2023-03, Vol.43 (3), p.155-165

2023

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Phase I pharmacokinetic and pharmacogenomic study of E7070 administered once every 21 days

Cancer science, 2005-10, Vol.96 (10), p.721-728

2005

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Exposure‐response modeling to describe the change in brain amyloid following lecanemab administration in patients with early Alzheimer’s disease

Alzheimer's & dementia, 2023-12, Vol.19 (S21), p.n/a

2023

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Effects of Food, Gastric Acid Reduction, and Strong CYP3A Induction on the Pharmacokinetics of Tasurgratinib, a Novel Selective Fibroblast Growth Factor Receptor Inhibitor

Journal of clinical pharmacology, 2024-08

2024

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PK/PD analyses of ARIA‐E and isolated ARIA‐H in Lecanemab Clarity AD study

Alzheimer's & dementia, 2023-12, Vol.19 (S21), p.n/a

2023

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Modeled Impact of APOE4 Genotype on ARIA‐E Incidence in Patients Treated With Lecanemab

Alzheimer's & dementia, 2022-12, Vol.18 (S10), p.n/a

2022

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Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects

International journal of clinical pharmacology and therapeutics, 2020-12, Vol.58 (12), p.757-764

2020

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Abstract PS12-15: Pharmacokinetics of H3B-6545 in patients with locally advanced or metastatic estrogen receptor-positive HER2 negative breast cancer (ER+ and HER2- BC)

Cancer research (Chicago, Ill.), 2021-02, Vol.81 (4_Supplement), p.PS12-15-PS12-15

2021

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Dose optimization for MORAb-202, an antibody-drug conjugate (ADC) highly selective for folate receptor-alpha (FRα), using population pharmacokinetic (PPK) and exposure-response (E-R) efficacy and safety analyses

Journal of clinical oncology, 2022-06, Vol.40 (16_suppl), p.3090-3090

2022

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Subcutaneous Dose Selection of Lecanemab for Treatment of Subjects with Early Alzheimer’s Disease (EAD)

Alzheimer's & dementia, 2022-12, Vol.18 (S10), p.n/a

2022

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Amino Acids in the N-Terminal Region Regulate the Photocycle of Photoactive Yellow Protein

Journal of biochemistry (Tokyo), 2001-07, Vol.130 (1), p.51-56

2001

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Pharmacokinetic/pharmacodynamic drug–drug interactions of avatrombopag when coadministered with dual or selective CYP2C9 and CYP3A interacting drugs

British journal of clinical pharmacology, 2018-05, Vol.84 (5), p.952-960

2018

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Population pharmacokinetics and exposure-response analyses of safety (ARIA-E and isolated ARIA-H) of lecanemab in subjects with early Alzheimer's disease

CPT: pharmacometrics and systems pharmacology, 2024-08

2024

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ELENBECESTAT, A NOVEL BACE INHIBITOR, DEMONSTRATES SIMILAR PHARMACOKINETICS AND TOLERABILITY IN JAPANESE SUBJECTS WITH MULTIPLE DOSINGS

Alzheimer's & dementia, 2018-07, Vol.14 (7), p.P282-P282

2018

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P1‐040: ELENBECESTAT, A NOVEL BACE INHIBITOR, DEMONSTRATES SIMILAR PHARMACOKINETICS AND TOLERABILITY IN JAPANESE SUBJECTS WITH MULTIPLE DOSINGS

Alzheimer's & dementia, 2018-07, Vol.14 (7S_Part_5), p.P282-P282

2018

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5. Pharmacogenomics Application into Clinical Trial

Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics, 2010, Vol.41(4), pp.176-180

YASUDA, Sanae

2010

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Safety, pharmacokinetics, and pharmacodynamics in first-in-human study of a novel compound E6742, a Toll-like receptor 7 and 8 antagonist

Proceedings for Annual Meeting of The Japanese Pharmacological Society, 2018, Vol.WCP2018, p.PO1-11-13

2018

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A Point of Consider on Credible and Efficient Dose Selection Based on the Exposure-Response Relationship

Rinshō yakuri, 2005, Vol.36 (5), p.247-253

2005

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Comparison of the kinetic disposition and metabolism of E3810, a new proton pump inhibitor, and omeprazole in relation to S‐mephenytoin 4′‐hydroxylation status

Clinical pharmacology and therapeutics, 1995-08, Vol.58 (2), p.143-154

1995

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Concentration–Response Modeling of ECG Data From Early‐Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk — Experience From the Development Program of Lemborexant

Population pharmacokinetic‐pharmacodynamic analyses of amyloid positron emission tomography and plasma biomarkers for lecanemab in subjects with early Alzheimer's disease

Population pharmacokinetic‐pharmacodynamic modeling of serum biomarkers as predictors of tumor dynamics following lenvatinib treatment in patients with radioiodine‐refractory differentiated thyroid cancer (RR‐DTC)

A combined physiologically‐based pharmacokinetic and quantitative systems pharmacology model for modeling amyloid aggregation in Alzheimer's disease

Pharmacokinetics of Perampanel in Healthy Korean, White, and Japanese Adult Subjects

Exposure-Response Modeling to Describe Change in Brain Amyloid Following Lecanemab Administration in Patients with Early Alzheimer’s Disease (P9-9.011)

A Single- and Multiple-Dose Pharmacokinetic Study of Oral Perampanel in Healthy Chinese Subjects

Phase I pharmacokinetic and pharmacogenomic study of E7070 administered once every 21 days

Exposure‐response modeling to describe the change in brain amyloid following lecanemab administration in patients with early Alzheimer’s disease

Effects of Food, Gastric Acid Reduction, and Strong CYP3A Induction on the Pharmacokinetics of Tasurgratinib, a Novel Selective Fibroblast Growth Factor Receptor Inhibitor

PK/PD analyses of ARIA‐E and isolated ARIA‐H in Lecanemab Clarity AD study

Modeled Impact of APOE4 Genotype on ARIA‐E Incidence in Patients Treated With Lecanemab

Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects

Abstract PS12-15: Pharmacokinetics of H3B-6545 in patients with locally advanced or metastatic estrogen receptor-positive HER2 negative breast cancer (ER+ and HER2- BC)

Dose optimization for MORAb-202, an antibody-drug conjugate (ADC) highly selective for folate receptor-alpha (FRα), using population pharmacokinetic (PPK) and exposure-response (E-R) efficacy and safety analyses

Subcutaneous Dose Selection of Lecanemab for Treatment of Subjects with Early Alzheimer’s Disease (EAD)

Amino Acids in the N-Terminal Region Regulate the Photocycle of Photoactive Yellow Protein

Pharmacokinetic/pharmacodynamic drug–drug interactions of avatrombopag when coadministered with dual or selective CYP2C9 and CYP3A interacting drugs

Population pharmacokinetics and exposure-response analyses of safety (ARIA-E and isolated ARIA-H) of lecanemab in subjects with early Alzheimer's disease

ELENBECESTAT, A NOVEL BACE INHIBITOR, DEMONSTRATES SIMILAR PHARMACOKINETICS AND TOLERABILITY IN JAPANESE SUBJECTS WITH MULTIPLE DOSINGS

P1‐040: ELENBECESTAT, A NOVEL BACE INHIBITOR, DEMONSTRATES SIMILAR PHARMACOKINETICS AND TOLERABILITY IN JAPANESE SUBJECTS WITH MULTIPLE DOSINGS

5. Pharmacogenomics Application into Clinical Trial

Safety, pharmacokinetics, and pharmacodynamics in first-in-human study of a novel compound E6742, a Toll-like receptor 7 and 8 antagonist

A Point of Consider on Credible and Efficient Dose Selection Based on the Exposure-Response Relationship

Comparison of the kinetic disposition and metabolism of E3810, a new proton pump inhibitor, and omeprazole in relation to S‐mephenytoin 4′‐hydroxylation status

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