Howard Lee

发表

Simulation of Correlated Continuous and Categorical Variables using a Single Multivariate Distribution

D. Mould, C. Peck, N. Holford, 2006, Journal of Pharmacokinetics and Pharmacodynamics.

A physiologically‐based pharmacokinetic model adequately predicted the human pharmacokinetic profiles of YH4808, a novel K+‐competitive acid blocker

K. Yu, Howard Lee, S. Jang, 2019, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Altered Gene Expression Profiles in Peripheral Blood Mononuclear Cells in Obese Subjects

Howard Lee, T. Tong, T. Park, 2020, Obesity Facts.

Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013

C. Peck, K. Yu, Howard Lee, 2016, Drug design, development and therapy.

Evidence of effectiveness: How much can we extrapolate from existing studies?

C. Peck, D. Yim, Honghui Zhou, 2005, The AAPS Journal.

Scientific considerations for global drug development

R. Altman, K. Giacomini, Steven Edward Kern, 2020, Science Translational Medicine.

A fixed-dose combination tablet of gemigliptin and metformin sustained release has comparable pharmacodynamic, pharmacokinetic, and tolerability profiles to separate tablets in healthy subjects

Sang-In Park, K. Yu, I. Jang, 2015, Drug design, development and therapy.

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Fimasartan Following Single and Repeated Oral Administration in the Fasted and Fed States in Healthy Subjects

Ji Han Kim, Howard Lee, H. Tan, 2011, American journal of cardiovascular drugs : drugs, devices, and other interventions.

New tablet formulation of tacrolimus with smaller interindividual variability may become a better treatment option than the conventional capsule formulation in organ transplant patients

Howard Lee, Anhye Kim, Yu Kyong Kim, 2017, Drug design, development and therapy.

Evaluation of the pharmacokinetic and pharmacodynamic drug interactions between cilnidipine and valsartan, in healthy volunteers

K. Yu, K. Lim, Howard Lee, 2014, Drug design, development and therapy.

Effects of HM30181, a P-glycoprotein inhibitor, on the pharmacokinetics and pharmacodynamics of loperamide in healthy volunteers.

Joo-Youn Cho, K. Yu, I. Jang, 2014, British journal of clinical pharmacology.

Pharmacokinetic and Pharmacodynamic Interaction Between Gemigliptin and Metformin in Healthy Subjects

Y. Cho, Joo-Youn Cho, K. Yu, 2014, Clinical Drug Investigation.

Sustained Increase in the Oral Bioavailability of Loperamide after a Single Oral Dose of HM30181, a P‐glycoprotein Inhibitor, in Healthy Male Participants

Joo-Youn Cho, K. Yu, Jae-Yong Chung, 2013, Basic & clinical pharmacology & toxicology.

Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Howard Lee, 2015, The AAPS Journal.

What Does it Take to Make Model-Informed Precision Dosing Common Practice? Report from the 1st Asian Symposium on Precision Dosing

M. Jamei, D. Yim, A. Rostami-Hodjegan, 2019, The AAPS Journal.

A double‐blind, placebo‐controlled, single‐ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15136, a novel long‐acting glucagon analogue, in healthy subjects

Y. Cho, Howard Lee, J. Hwang, 2020, Diabetes, obesity & metabolism.

A population PK–PD model of YH4808, a novel P‐CAB, and intragastric pH that incorporated negative feedback by increased intragastric pH onto the systemic exposure to YH4808

K. Yu, Howard Lee, S. Jang, 2022, CPT: pharmacometrics & systems pharmacology.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

Howard Lee, Heechan Lee, J. Baik, 2017, Drug design, development and therapy.

Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Howard Lee, Howard Lee, 2013, The AAPS Journal.

hIL‐7‐hyFc, A Long‐Acting IL‐7, Increased Absolute Lymphocyte Count in Healthy Subjects

Se-Hwan Yang, Y. Sung, E. Shin, 2020, Clinical and translational science.

An assessment of the pharmacokinetics, pharmacodynamics, and tolerability of GCPGC, a novel pegylated granulocyte colony-stimulating factor (G-CSF), in healthy subjects

K. Yu, I. Jang, K. Lim, 2014, Investigational new drugs.

Novel nanocrystal formulation of megestrol acetate has improved bioavailability compared with the conventional micronized formulation in the fasting state

Joo-Youn Cho, K. Yu, I. Jang, 2014, Drug design, development and therapy.

Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Howard Lee, 2015, The AAPS Journal.

Clonidine Clearance Matures Rapidly During the Early Postnatal Period: A Population Pharmacokinetic Analysis in Newborns With Neonatal Abstinence Syndrome

Hong-Guang Xie, C. Hendrix, Ying-Jun Cao, 2011, Journal of clinical pharmacology.

Suboptimal Aminoglycoside Dosing in Critically Ill Patients

R. Bies, K. Bigos, Howard Lee, 2008, Therapeutic drug monitoring.

Population Pharmacokinetics of Golimumab, an Anti‐Tumor Necrosis Factor‐α Human Monoclonal Antibody, in Patients With Psoriatic Arthritis

C. Wagner, Honghui Zhou, T. Vu, 2009, Journal of clinical pharmacology.

Population Pharmacokinetic Analysis and Simulation of the Time‐Concentration Profile of Etanercept in Pediatric Patients With Juvenile Rheumatoid Arthritis

I. Nestorov, C. Peck, D. Yim, 2005, Journal of clinical pharmacology.

Comparative steady-state pharmacokinetic study of an extended-release formulation of itopride and its immediate-release reference formulation in healthy volunteers

Joo-Youn Cho, K. Yu, I. Jang, 2014, Drug design, development and therapy.

Pharmacokinetics and tolerability of apremilast in healthy Korean adult men

Howard Lee, M. Palmisano, F. Ramírez-Valle, 2021, Clinical and translational science.

The Current Status of Drug Repositioning and Vaccine Developments for the COVID-19 Pandemic

Howard Lee, Jung-Hyun Won, 2020, International journal of molecular sciences.

A bioequivalence study of two levofloxacin tablets in healthy male subjects

S. Yim, I. Jang, Howard Lee, 2014 .

Population pharmacokinetic and pharmacodynamic modeling of etanercept using logistic regression analysis

Ivan Nestorov, I. Nestorov, C. Peck, 2003, Clinical pharmacology and therapeutics.

A Population Pharmacokinetic Analysis of Fimasartan, a Selective Angiotensin II Receptor Antagonist, in Healthy Caucasian Subjects and Korean Patients With Hypertension

B. Oh, K. Yu, I. Jang, 2013, Clinical pharmacology in drug development.

A thorough QT study to evaluate the QTc prolongation potential of two neuropsychiatric drugs, quetiapine and escitalopram, in healthy volunteers

Joo-Youn Cho, K. Yu, I. Jang, 2016, International clinical psychopharmacology.

What Does it Take to Make Model-Informed Precision Dosing Common Practice? Report from the 1st Asian Symposium on Precision Dosing

M. Jamei, D. Yim, A. Rostami-Hodjegan, 2019, The AAPS Journal.

Pharmacokinetics, pharmacodynamics, and tolerability of LC350189, a novel xanthine oxidase inhibitor, in healthy subjects

K. Yu, I. Jang, Howard Lee, 2015, Drug design, development and therapy.

Development of a Pharmacokinetic Model Describing Neonatal Fc Receptor‐Mediated Recycling of HL2351, a Novel Hybrid Fc‐Fused Interleukin‐1 Receptor Antagonist, to Optimize Dosage Regimen

Howard Lee, J. Chae, Hyun‐moon Back, 2020, CPT: pharmacometrics & systems pharmacology.

Ambulatory blood pressure response to once-daily fimasartan: an 8-week, multicenter, randomized, double-blind, active-comparator, parallel-group study in Korean patients with mild to moderate essential hypertension.

M. Jeong, S. Chae, B. Oh, 2013, Clinical therapeutics.

A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults

K. Park, Jaehwi Lee, Ahnul Ha, 2021, Clinical and translational science.

Policy Suggestions to Improve Patient Access to New Drugs in Korea

Howard Lee, Yoona Choi, 2021 .

Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate After Single-dose Administration in Healthy Korean Male Subjects.

K. Yu, I. Jang, Howard Lee, 2017, Clinical therapeutics.

The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans

Joo-Youn Cho, K. Yu, I. Jang, 2017, PloS one.

Postmarketing drug dosage changes of 499 FDA‐approved new molecular entities, 1980–1999

Carl Peck, C. Peck, Howard Lee, 2002, Pharmacoepidemiology and drug safety.

Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Howard Lee, 2013, The AAPS Journal.

Safety, tolerability and pharmacokinetics and pharmacodynamics of HL2351, a novel hybrid fc‐fused interleukin‐1 receptor antagonist, in healthy subjects: A first‐in‐human study

Hyunyee Yoon, S. Yoon, Howard Lee, 2020, British journal of clinical pharmacology.

Can the COVID-19 Pandemic Disrupt the Current Drug Development Practices?

Howard Lee, Jung-Hyun Won, 2021, International journal of molecular sciences.

Genetic algorithm guided population pharmacokinetic model development for simvastatin, concurrently or non‐concurrently co‐administered with amlodipine

Ayyappa Chaturvedula, Howard Lee, A. Chaturvedula, 2014, Journal of clinical pharmacology.

Predictive performance of gentamicin dosing nomograms

K. Yu, K. Lim, Howard Lee, 2014, Drug Design, Development and Therapy.

A pharmacokinetic comparison of two voriconazole formulations and the effect of CYP2C19 polymorphism on their pharmacokinetic profiles

Joo-Youn Cho, K. Yu, I. Jang, 2015, Drug design, development and therapy.

Tissue pharmacokinetics of DHP107, a novel lipid‐based oral formulation of paclitaxel, in mice and patients by positron emission tomography

S. Woo, Howard Lee, Sang Eun Kim, 2021, Clinical and translational science.

Effects of Proton Pump Inhibitors on Metformin Pharmacokinetics and Pharmacodynamics

Joo-Youn Cho, K. Yu, I. Jang, 2014, Drug Metabolism and Disposition.

Pediatric patients undergoing hematopoietic stem cell transplantation can greatly benefit from a novel once‐daily intravenous busulfan dosing nomogram

Ji Won Lee, K. Yu, S. Song, 2017, American journal of hematology.

Data exclusivity through New Drug Reexamination in Korea: sibutramine hydrochloride (Reductil®) vs. sibutramine mesylate (Slimmer®) as an example

Howard Lee, 2018, Translational and Clinical Pharmacology.

A novel K+ competitive acid blocker, YH4808, sustains inhibition of gastric acid secretion with a faster onset than esomeprazole: randomised clinical study in healthy volunteers

S. Yoon, Sumin Yoon, S. Yi, 2017, Alimentary pharmacology & therapeutics.

LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects

Joo-Youn Cho, K. Yu, I. Jang, 2017, BioDrugs.

Y. Cho, Howard Lee, J. Hwang, 2021, Diabetes, obesity & metabolism.

Suboptimal Aminoglycoside Dosing in Critically Ill Patients

R. Bies, K. Bigos, Howard Lee, 2008, Therapeutic drug monitoring.

An Accelerator Mass Spectrometry‐Enabled Microtracer Study to Evaluate the First‐Pass Effect on the Absorption of YH4808

S. Dueker, A. Kim, I. Jang, 2017, Clinical pharmacology and therapeutics.