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Generating Model Integrated Evidence for Generic Drug Development and Assessment

Clinical pharmacology and therapeutics, 2019-02, Vol.105 (2), p.338-349

2019

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Clinical Pharmacology in Women's Health: Current Status and Opportunities

Journal of clinical pharmacology, 2020-12, Vol.60 (S2), p.S7-S10

2020

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FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

The New England journal of medicine, 2016-01, Vol.374 (2), p.101-104

2016

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Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States

Journal of clinical pharmacology, 2020-12, Vol.60 (S2), p.S34-S38

2020

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Development of the multiplex imaging chamber at PAL-XFEL

Journal of synchrotron radiation, 2024-05, Vol.31 (Pt 3), p.469-477

2024

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Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens

Journal of clinical pharmacology, 2020-12, Vol.60 (S2), p.S103-S109

2020

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Establishment of a Disease‐Drug Trial Model for Postmenopausal Osteoporosis: A Zoledronic Acid Case Study

Journal of clinical pharmacology, 2020-12, Vol.60 (S2), p.S86-S102

2020

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Role of CYP3A in Oral Contraceptives Clearance

Clinical and translational science, 2018-05, Vol.11 (3), p.251-260

2018

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Use of physiologically‐based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended‐release nifedipine

CPT: pharmacometrics and systems pharmacology, 2024-02, Vol.13 (2), p.247-256

2024

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Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

Clinical pharmacology and therapeutics, 2019-07, Vol.106 (1), p.174-181

2019

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Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

Clinical pharmacology and therapeutics, 2022-11, Vol.112 (5), p.982-989

2022

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FDA Approval of Paroxetine for Menopausal Hot Flushes

The New England journal of medicine, 2014-05, Vol.370 (19), p.1777-1779

2014

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Model‐Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Clinical pharmacology and therapeutics, 2018-07, Vol.104 (1), p.27-30

2018

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Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

CPT: pharmacometrics and systems pharmacology, 2023-05, Vol.12 (5), p.585-597

2023

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Design optimization for broadband sound insulation by double-panel structure with a slot-type Helmholtz resonator array at low frequency range

Indian journal of physics, 2024, Vol.98 (9), p.3179-3189

2024

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FDA Public Meeting Report on “Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications”

Journal of clinical pharmacology, 2018-12, Vol.58 (12), p.1655-1665

2018

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Development of a Fast Sample-exchange System for Fixed Target Single-shot Imaging at PAL-XFEL

Journal of the Korean Physical Society, 2020, 76(6), , pp.448-452

2020

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Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

Pharmaceutics, 2023-09, Vol.15 (9), p.2366

2023

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A method for minimizing the zone of low water flow velocity in a bottom center drain circular aquaculture tank

Journal of the World Aquaculture Society, 2021-12, Vol.52 (6), p.1221-1233

2021

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Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users

Clinical and translational science, 2021-09, Vol.14 (5), p.1977-1987

2021

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Regulatory Perspectives in Pharmacometric Models of Osteoporosis

Journal of clinical pharmacology, 2018-05, Vol.58 (5), p.572-585

2018

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Model‐Based Assessment Using Conventional Bioequivalence Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement

Journal of clinical pharmacology, 2017-12, Vol.57 (12), p.1591-1599

2017

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Improvement of Sound Insulation Through Double-Panel Structure by Using Hybrid Local Resonator Array

Archives of acoustics, 2023-01, Vol.48 (1), p.63-70

2023

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Single-Shot Coherent X-ray Imaging Instrument at PAL-XFEL

Applied sciences, 2021-06, Vol.11 (11), p.5082

2021

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A Regulatory Science Perspective on Warfarin Therapy: A Pharmacogenetic Opportunity

Journal of clinical pharmacology, 2009-02, Vol.49 (2), p.138-146

2009

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Generating Model Integrated Evidence for Generic Drug Development and Assessment

Clinical Pharmacology in Women's Health: Current Status and Opportunities

FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

Regulatory Science to Promote Access to Intrauterine Systems for Women in the United States

Development of the multiplex imaging chamber at PAL-XFEL

Impact of Sex on Clinical Response in Rheumatoid Arthritis Patients Treated With Biologics at Approved Dosing Regimens

Establishment of a Disease‐Drug Trial Model for Postmenopausal Osteoporosis: A Zoledronic Acid Case Study

Role of CYP3A in Oral Contraceptives Clearance

Use of physiologically‐based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended‐release nifedipine

Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology

Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

FDA Approval of Paroxetine for Menopausal Hot Flushes

Model‐Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

Design optimization for broadband sound insulation by double-panel structure with a slot-type Helmholtz resonator array at low frequency range

FDA Public Meeting Report on “Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications”

Development of a Fast Sample-exchange System for Fixed Target Single-shot Imaging at PAL-XFEL

Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

A method for minimizing the zone of low water flow velocity in a bottom center drain circular aquaculture tank

Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users

Regulatory Perspectives in Pharmacometric Models of Osteoporosis

Model‐Based Assessment Using Conventional Bioequivalence Limits to Ensure Safety and Efficacy of Rivaroxaban in Patients Undergoing Hip or Knee Replacement

Improvement of Sound Insulation Through Double-Panel Structure by Using Hybrid Local Resonator Array

Single-Shot Coherent X-ray Imaging Instrument at PAL-XFEL

A Regulatory Science Perspective on Warfarin Therapy: A Pharmacogenetic Opportunity

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