Shiew Mei Huang (Shiew-Mei Huang)

ORCID

Publication Activity (10 Years)

Years Active: 2020-2024
Publications (10 Years): 26

Top Venues

Clinical pharmacology and therapeutics

CPT: pharmacometrics & systems pharmacology

Cancer research communications

US Food and Drug Administration

This page only lists publications with an associated author ORCID identifier.

Affiliation History

US Food and Drug Administration Sep 16 1996

United States

Deputy Director, OCP :: Office of Clinical Pharmacology (OCP)/OTS/CDER

Publications

Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Ozlem Belen, Van Tran, Rebecca Chiu, Karen M Higgins, Jianmeng Chen, Lei He, Suresh Doddapaneni, Shiew Mei Huang, Nikolay P Nikolov, Issam Zineh
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization. Clinical pharmacology and therapeutics 115 (4) (2024)
Zhe Li, Xiulian Du, Shiew Mei Huang, Yow-Ming C Wang
Pharmacokinetics-Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap. Clinical pharmacology and therapeutics (2024)
Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Ozlem Belen, Van Tran, Rebecca Chiu, Karen M Higgins, Jianmeng Chen, Lei He, Suresh Doddapaneni, Shiew Mei Huang, Nikolay P Nikolov, Issam Zineh
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization. Clinical pharmacology and therapeutics (2024)
Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Ozlem Belen, Van Tran, Rebecca Chiu, Karen M Higgins, Jianmeng Chen, Lei He, Suresh Doddapaneni, Shiew Mei Huang, Nikolay P Nikolov, Issam Zineh
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization. Clinical pharmacology and therapeutics 115 (4) (2024)
Zhe Li, Xiulian Du, Shiew Mei Huang, Yow-Ming C Wang
Pharmacokinetics-Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap. Clinical pharmacology and therapeutics 115 (3) (2024)
Zhe Li, Xiulian Du, Shiew Mei Huang, Yow-Ming C Wang
Pharmacokinetics-Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap. Clinical pharmacology and therapeutics 115 (3) (2024)
Juan J L Lertora, Shiew Mei Huang, Alfred L George
In Memoriam Arthur J. Atkinson, Jr. (1938-2024). Clinical pharmacology and therapeutics (2024)
Yow-Ming C Wang, Ping Ji, Sudharshan Hariharan, Jie Wang, Olanrewaju O Okusanya, Bilal Abuasal, Hao Zhu, Rajanikanth Madabushi, Shiew Mei Huang, Issam Zineh
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Clinical pharmacology and therapeutics 115 (3) (2024)
Yow-Ming C Wang, Ping Ji, Sudharshan Hariharan, Jie Wang, Olanrewaju O Okusanya, Bilal Abuasal, Hao Zhu, Rajanikanth Madabushi, Shiew Mei Huang, Issam Zineh
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Clinical pharmacology and therapeutics 115 (3) (2024)
Yow-Ming C Wang, Ping Ji, Sudharshan Hariharan, Jie Wang, Olanrewaju O Okusanya, Bilal Abuasal, Hao Zhu, Rajanikanth Madabushi, Shiew Mei Huang, Issam Zineh
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Clinical pharmacology and therapeutics 115 (3) (2024)
Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Ozlem Belen, Van Tran, Rebecca Chiu, Karen M Higgins, Jianmeng Chen, Lei He, Suresh Doddapaneni, Shiew Mei Huang, Nikolay P Nikolov, Issam Zineh
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization. Clinical pharmacology and therapeutics 115 (4) (2024)
Qi Liu, Raj Nair, Ruihao Huang, Hao Zhu, Austin Anderson, Ozlem Belen, Van Tran, Rebecca Chiu, Karen M Higgins, Jianmeng Chen, Lei He, Suresh Doddapaneni, Shiew Mei Huang, Nikolay P Nikolov, Issam Zineh
Using Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization. Clinical pharmacology and therapeutics 115 (4) (2024)
Yow-Ming C Wang, Ping Ji, Sudharshan Hariharan, Jie Wang, Olanrewaju O Okusanya, Bilal Abuasal, Hao Zhu, Rajanikanth Madabushi, Shiew Mei Huang, Issam Zineh
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Clinical pharmacology and therapeutics (2024)
Yow-Ming C Wang, Ping Ji, Sudharshan Hariharan, Jie Wang, Olanrewaju O Okusanya, Bilal Abuasal, Hao Zhu, Rajanikanth Madabushi, Shiew Mei Huang, Issam Zineh
Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic Proteins. Clinical pharmacology and therapeutics (2024)
Zhe Li, Xiulian Du, Shiew Mei Huang, Yow-Ming C Wang
Pharmacokinetics-Bridging Between Autoinjectors and Prefilled Syringes for Subcutaneous Injection: Case Examples Revealing a Knowledge Gap. Clinical pharmacology and therapeutics 115 (3) (2024)
Qi Liu, Raina Mathur, Yuan Xu, Aracelis Z Torres, Rebecca A Miksad, Chao Liu, Haixia Smithson, Yaning Wang, Hao Zhu, Brian Booth, Shiew Mei Huang, Jizu Zhi, Rajeshwari Sridhara, Gideon Michael Blumenthal, Erin Larkins, MPallavi S Mishra-Kalyani, Donna R Rivera, Paul G Kluetz, Elad Sharon
The Association between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients with Non-Small Cell Lung Cancer Treated with a PD-1/L1 Blocking Antibody using Real-World and Trials Data. Clinical pharmacology and therapeutics (2023)
Qi Liu, Raina Mathur, Yuan Xu, Aracelis Z Torres, Rebecca A Miksad, Chao Liu, Haixia Smithson, Yaning Wang, Hao Zhu, Brian Booth, Shiew Mei Huang, Jizu Zhi, Rajeshwari Sridhara, Gideon Michael Blumenthal, Erin Larkins, Pallavi S Mishra-Kalyani, Donna R Rivera, Paul G Kluetz, Elad Sharon
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. Clinical pharmacology and therapeutics (2023)
Qi Liu, Chenan Zhang, Yue Huang, Ruihao Huang, Shiew Mei Huang, Erin Larkins, Liza Stapleford, Donna R Rivera, Paul G Kluetz, Shenggang Wang, Hao Zhu, James L Weese, Elizabeth Cromartie, Mahder Teka, Sheetal Walters, Frank M Wolf, Thomas D Brown
Evaluating Pneumonitis Incidence in Patients with Non-small Cell Lung Cancer Treated with Immunotherapy and/or Chemotherapy Using Real-world and Clinical Trial Data. Cancer research communications 3 (2) (2023)
Qi Liu, Chenan Zhang, Yue Huang, Ruihao Huang, Shiew Mei Huang, Erin Larkins, Liza Stapleford, Donna R Rivera, Paul G Kluetz, Shenggang Wang, Hao Zhu, James L Weese, Elizabeth Cromartie, Mahder Teka, Sheetal Walters, Frank M Wolf, Thomas D Brown
Evaluating Pneumonitis Incidence in Patients with Non-small Cell Lung Cancer Treated with Immunotherapy and/or Chemotherapy Using Real-world and Clinical Trial Data. Cancer research communications 3 (2) (2023)
Kathleen M Giacomini, Shiew Mei Huang
More Than Pharmacokinetics: Transporters in Clinical Pharmacology. Clinical pharmacology and therapeutics 112 (3) (2022)
Qi Liu, Ruihao Huang, Julie Hsieh, Hao Zhu, Mo Tiwari, Guansheng Liu, Daphney Jean, M Khair ElZarrad, Tala Fakhouri, Steven Berman, Billy Dunn, Matthew C Diamond, Shiew Mei Huang
Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021. Clinical pharmacology and therapeutics (2022)
Fang Li, Qin Sun, Shengnan Du, Jeffry Florian, Yaning Wang, Shiew Mei Huang, Issam Zineh, Yow-Ming C Wang
Model-Based Approach to Selecting Pegfilgrastim Dose for Pharmacokinetic and Pharmacodynamic Similarity Studies in Biosimilar Development. Clinical pharmacology and therapeutics (2022)
Xinning Yang, Kellie Reynolds, Rajanikanth Madabushi, Shiew Mei Huang
Current Perspective on Residual Knowledge Gaps in the Assessment of Transporter-Mediated Drug Interactions. Clinical pharmacology and therapeutics 112 (3) (2022)
Qi Liu, Janice B Schwartz, Patricia W Slattum, S W Johnny Lau, Daphne Guinn, Rajanikanth Madabushi, Gilbert J Burckart, Robert M Califf, Francesca Cerreta, Carolyn Cho, Jack Cook, Jamie Gamerman, Paul Goldsmith, Piet H van der Graaf, Jerry H Gurwitz, Sebastian Haertter, Sarah Nicole Hilmer, Shiew Mei Huang, Sharon K Inouye, Bindu Kanapuru, Munir Pirmohamed, Phil Posner, Barbara Radziszewska, H Keipp Talbot, Robert Temple
Roadmap to 2030 for Drug Evaluation in Older Adults. Clinical pharmacology and therapeutics (2021)
Daniel Scotcher, Vikram Arya, Xinning Yang, Ping Zhao, Lei Zhang, Shiew Mei Huang, Amin Rostami-Hodjegan, Aleksandra Galetin
A Novel Physiologically Based Model of Creatinine Renal Disposition to Integrate Current Knowledge of Systems Parameters and Clinical Observations. CPT: pharmacometrics & systems pharmacology 9 (6) (2020)
Daniel Scotcher, Vikram Arya, Xinning Yang, Ping Zhao, Lei Zhang, Shiew Mei Huang, Amin Rostami-Hodjegan, Aleksandra Galetin
Mechanistic Models as Framework for Understanding Biomarker Disposition: Prediction of Creatinine-Drug Interactions. CPT: pharmacometrics & systems pharmacology 9 (5) (2020)

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Publication Activity (10 Years)

Top Topics

Top Venues

Shiew Mei Huang (Shiew-Mei Huang)