Hao Zhu

Jiang Liu, Shiew-Mei Huang, Jianghong Fan, 2020, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

Water-Insoluble Drugs and Their Pharmacokinetic Behaviors

Honghui Zhou, Hao Zhu, 2018 .

Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations

Justin C. Earp, Jiang Liu, Shiew-Mei Huang, 2021, CPT: pharmacometrics & systems pharmacology.

Influence of age on the relationship between apixaban concentration and anti-factor Xa activity in older patients with non-valvular atrial fibrillation.

Hao Zhu, Yaning Wang, Qi Liu, 2021, International journal of cardiology.

Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic

Justin C. Earp, Jiang Liu, Jianghong Fan, 2021, Clinical pharmacology and therapeutics.

Model-Informed Drug Development Approach Supporting Approval of Adalimumab (HUMIRA) in Adolescent Patients with Hidradenitis Suppurativa: a Regulatory Perspective

Jiang Liu, Hao Zhu, Yaning Wang, 2019, The AAPS Journal.

Model‐Informed Drug Development: A Regulatory Perspective on Progress

D. Strauss, I. Zineh, Shiew-Mei Huang, 2019, Clinical pharmacology and therapeutics.

The US Food and Drug Administration's perspective on the new antidepressant vortioxetine.

E. Unger, R. Temple, A. Jackson, 2015, Journal of Clinical Psychiatry.

Toward Bridging Unmet Medical Need in Early Alzheimer’s Disease: An Evaluation of Beta‐Amyloid (Aβ) Plaque Burden as a Potential Drug Development Tool

Shiew-Mei Huang, Hao Zhu, Yaning Wang, 2022, Clinical pharmacology and therapeutics.

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

Liang Zhao, Hao Zhu, R. Madabushi, 2022, Pharmaceutical Research.

Effects of sedative psychotropic drugs combined with oxycodone on respiratory depression in the rat

D. Strauss, Vikram Patel, M. Matta, 2021, Clinical and translational science.

Application of machine learning based methods in exposure–response analysis

Hao Zhu, Yaning Wang, Qi Liu, 2022, Journal of Pharmacokinetics and Pharmacodynamics.

A novel approach for personalized response model: deep learning with individual dropout feature ranking

Hao Zhu, Yaning Wang, M. Gopalakrishnan, 2020, Journal of Pharmacokinetics and Pharmacodynamics.

Model-Informed Approach Supporting Approval of Adalimumab (HUMIRA) in Pediatric Patients with Ulcerative Colitis from a Regulatory Perspective

Jiang Liu, Hao Zhu, Yaning Wang, 2022, The AAPS Journal.

A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development

P. Bonate, D. Yin, D. Bottino, 2023, Journal of Pharmacokinetics and Pharmacodynamics.

Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective

Lei Zhang, R. Uppoor, R. Lionberger, 2021, Clinical pharmacology and therapeutics.

Partial Area Under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments

Lawrence X. Yu, R. Uppoor, Hao Zhu, 2014 .

Evaluating Pneumonitis Incidence in Patients with Non–small Cell Lung Cancer Treated with Immunotherapy and/or Chemotherapy Using Real-world and Clinical Trial Data

Shiew-Mei Huang, Chenan Zhang, P. Kluetz, 2023, Cancer research communications.

Evaluation of false positive rate based on exposure–response analyses for two compounds in fixed-dose combination products

Yaning Wang, Hao Zhu, Yaning Wang, 2011, Journal of Pharmacokinetics and Pharmacodynamics.

Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021

B. Dunn, Shiew-Mei Huang, Hao Zhu, 2022, Clinical pharmacology and therapeutics.

Concentration‐QT Relationships Play a Key Role in the Evaluation of Proarrhythmic Risk During Regulatory Review

Norman Stockbridge, Yaning Wang, Christine E Garnett, 2008, Journal of clinical pharmacology.

An integrated clinical pharmacology approach for deriving dosing recommendations in a regulatory setting: Review of recent cases in psychiatry drugs

Hao Zhu, M. Mehta, Hobart L Rogers, 2013, Journal of clinical pharmacology.

Developing an animal model to detect drug–drug interactions impacting drug-induced respiratory depression

M. Matta, Katherine I Shea, Nageswara Rao Pilli, 2020, Toxicology reports.

Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018‐2019 Submissions to the US FDA's Office of Clinical Pharmacology

Shiew-Mei Huang, Jianghong Fan, Xinyuan Zhang, 2020, Journal of clinical pharmacology.

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

Yaning Wang, Justin C. Earp, Christoffer Tornoe, 2011, Clinical pharmacokinetics.

Model‐Informed Drug Development in Pediatric Dose Selection

Justin C. Earp, Jiang Liu, Xinyuan Zhang, 2021, Journal of clinical pharmacology.

Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

I. Zineh, D. Gonzalez, Hao Zhu, 2020, Clinical pharmacology and therapeutics.

Vandetanib for the Treatment of Symptomatic or Progressive Medullary Thyroid Cancer in Patients with Unresectable Locally Advanced or Metastatic Disease: U.S. Food and Drug Administration Drug Approval Summary

C. Garnett, R. Pazdur, Y. Moon, 2012, Clinical Cancer Research.

Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling

Hao Zhu, Chao Liu, Yaning Wang, 2019, Journal of clinical pharmacology.

Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases

Jiang Liu, Xinyuan Zhang, Hao Zhu, 2022, Journal of clinical pharmacology.

Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

Hao Zhu, Shiew-Mei Huang, Yaning Wang, 2019, Clinical pharmacology and therapeutics.

Long short-term memory recurrent neural network for pharmacokinetic-pharmacodynamic modeling.

Chao Liu, Yaning Wang, Qi Liu, 2020, International journal of clinical pharmacology and therapeutics.

The Trend of Increasing Placebo Response and Decreasing Treatment Effect in Schizophrenia Trials Continues: An Update From the US Food and Drug Administration.

R. Uppoor, Hao Zhu, M. Gopalakrishnan, 2020, The Journal of clinical psychiatry.

Chapter 15 – Bioavailability and Bioequivalence

Honghui Zhou, Hao Zhu, K. Seitz, 2009 .

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

Hao Zhu, Shiew-Mei Huang, Yaning Wang, 2019, CPT: pharmacometrics & systems pharmacology.

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

J. Polli, R. Lionberger, J. Gobburu, 2023, CPT: pharmacometrics & systems pharmacology.

Use of Model-Informed Drug Development to Streamline Development of Long-Acting Products: Can these Successes Be Translated to Long-Acting Hormonal Contraceptives?

P. Zhao, P. Balimane, Hao Zhu, 2020, Annual review of pharmacology and toxicology.

The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non‐Small Cell Lung Cancer Treated With a PD‐1/PD‐L1 Blocking Antibody Using Real‐World and Trial Data

Shiew-Mei Huang, G. Blumenthal, R. Sridhara, 2023, Clinical pharmacology and therapeutics.

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Justin C. Earp, D. Strauss, J. Bai, 2021, CPT: pharmacometrics & systems pharmacology.

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

Justin C. Earp, Christina M. Friedrich, K. Gadkar, 2021, The AAPS Journal.

A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development

David G Strauss, Justin C. Earp, Hao Zhu, 2020, CPT: pharmacometrics & systems pharmacology.

Exposure–response analyses of blood pressure and heart rate changes for methylphenidate in healthy adults

R. Uppoor, Hao Zhu, Yaning Wang, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.

R. Uppoor, Hao Zhu, M. Gopalakrishnan, 2020, JAMA psychiatry.

Chapter 14 – Bioavailability and Bioequivalence*

Lawrence X. Yu, R. Uppoor, Hao Zhu, 2017 .

Considerations for assessing the potential effects of antidiabetes drugs on cardiac ventricular repolarization: A report from the Cardiac Safety Research Consortium.

E. Michelson, P. Sager, S. Heller, 2015, American heart journal.

A Quantitative Justification of Similarity in Placebo Response Between Adults and Adolescents With Acute Exacerbation of Schizophrenia in Clinical Trials

R. Uppoor, Hao Zhu, M. Gopalakrishnan, 2019, Clinical pharmacology and therapeutics.

Extrapolation of Efficacy and Dose Selection in Pediatrics: A Case Example of Atypical Antipsychotics in Adolescents With Schizophrenia and Bipolar I Disorder

R. Uppoor, Hao Zhu, Yaning Wang, 2021, Journal of clinical pharmacology.

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

R. Uppoor, Hao Zhu, Yaning Wang, 2019, Clinical and Translational Science.

Considerations for Clinical Trial Design and Data Analyses of Thorough QT Studies Using Drug‐Drug Interaction

C. Garnett, J. Gobburu, Hao Zhu, 2010, Journal of clinical pharmacology.

Quantification of disease progression and dropout for Alzheimer's disease.

Yaning Wang, Jogarao Gobburu, J. Gobburu, 2013, International journal of clinical pharmacology and therapeutics.

Development of a placebo effect model combined with a dropout model for bipolar disorder

Hao Zhu, Yaning Wang, G. Hochhaus, 2013, Journal of Pharmacokinetics and Pharmacodynamics.

Training the next generation of pharmacometric modelers: a multisector perspective.

P. Bonate, B. Corrigan, M. Neely, 2023, Journal of pharmacokinetics and pharmacodynamics.

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

Jiang Liu, I. Zineh, Atiqur Rahman, 2023, CPT: pharmacometrics & systems pharmacology.

Population Pharmacokinetics of UCN-01

E. Sausville, M. Edelman, W. Figg, 2013 .

Full covariate modelling approach in population pharmacokinetics: understanding the underlying hypothesis tests and implications of multiplicity

Jinfeng Xu, Yaning Yang, Honghui Zhou, 2018, British journal of clinical pharmacology.