Hong Zhao

发表

Comparison of first-line chemotherapy based on irinotecan or other drugs to treat non-small cell lung cancer in stage IIIB/IV: a systematic review and meta-analysis

Dong Wang, Xue-qin Yang, Chongyi Li, 2015, BMC Cancer.

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

Vinod P. Shah, Lawrence X. Yu, Ajaz S. Hussain, 2002, Pharmaceutical Research.

U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Justin C. Earp, P. Keegan, R. Pazdur, 2010, Clinical Cancer Research.

FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions

Jiang Liu, Jielin Sun, Reena Philip, 2021, Clinical Cancer Research.

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen

Huanyu Chen, K. He, K. Goldberg, 2017, Clinical Cancer Research.

FDA Approval Summary: TAS-102

K. He, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer

K. He, P. Keegan, R. Pazdur, 2015, Clinical Cancer Research.

FDA Approval Summary: Ramucirumab for Gastric Cancer

Huanyu Chen, K. He, P. Keegan, 2015, Clinical Cancer Research.

Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a “Physician's Choice” Control Arm in a Randomized Approval Trial

Martha Donoghue, K. He, P. Keegan, 2012, Clinical Cancer Research.

American Association of Pharmaceutical Scientists National Biotechnology Conference Short Course: Translational Challenges in Developing Antibody-Drug Conjugates

B. Meibohm, Hong Zhao, H. Erickson, 2013, mAbs.

FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma

Jiang Liu, Martha Donoghue, R. Pazdur, 2021, Clinical Cancer Research.

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

K. He, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens

P. Keegan, R. Pazdur, Hong Zhao, 2008, Clinical Cancer Research.

Antibody–Drug Conjugate Development

A. Khandelwal, Hong Zhao, H. Saber, 2013 .

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum‐Containing Chemotherapy

K. Goldberg, P. Keegan, Amy McKee, 2017, The oncologist.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Huanyu Chen, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

Are hepatic impairment studies necessary for therapeutic proteins?

Hong Zhao, Atiqur Rahman, Jun Yang, 2013, Clinical therapeutics.

Pediatric Development of Molecularly Targeted Oncology Drugs

G. Reaman, Hong Zhao, G. Burckart, 2018, Clinical pharmacology and therapeutics.

Bridging Adult Experience to Pediatrics in Oncology Drug Development

G. Reaman, Hong Zhao, C. Stewart, 2017, Journal of clinical pharmacology.

Exposure-response (E-R) and case-control analyses of ramucirumab leading to recommendation for dosing optimization in patients with gastric cancer.

L. Fashoyin-Aje, P. Keegan, Hong Zhao, 2015 .

Fixed Dosing Versus Body Size—Based Dosing of Monoclonal Antibodies in Adult Clinical Trials

Hong Zhao, Diane D. Wang, K. Parivar, 2009, Journal of clinical pharmacology.

Benefit-Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy.

Jiang Liu, L. Fashoyin-Aje, Martha Donoghue, 2020, The oncologist.

FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors

Martha Donoghue, P. Keegan, R. Pazdur, 2020, Clinical Cancer Research.

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

Huanyu Chen, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

Food and Drug Administration Approval : Ofatumumab the Treatment of Patients with Chronic Lymphocytic R kemia Refractory to Fludarabine and Alemtuzumab

Justin C. Earp, P. Keegan, R. Pazdur, 2010 .

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

P. Keegan, R. Pazdur, A. Russell, 2013, Clinical Cancer Research.

New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process

Sang Chung, Sophia Abraham, Elena Karnaukhova, 2008, Journal of clinical pharmacology.

FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer.

Jiang Liu, R. Pazdur, Hong Zhao, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non–Small Cell Lung Cancer Following Crizotinib

Huanyu Chen, P. Keegan, Amy McKee, 2016, Clinical Cancer Research.

FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase–Positive Non–Small Cell Lung Cancer

Sean Khozin, Ping Zhao, Richard Pazdur, 2015, Clinical Cancer Research.

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non‐Small Cell Lung Cancer: First‐Line Therapy and Beyond

K. Goldberg, P. Keegan, Amy McKee, 2017, The oncologist.

FDA Approval Summary: Lurbinectedin for the Treatment of Metastatic Small Cell Lung Cancer

Jiang Liu, R. Pazdur, R. Pragani, 2020, Clinical Cancer Research.

Different Radiological Criteria for Early Tumor Response Evaluation in Patients With Unresectable Hepatocellular Carcinoma Treated With Anti-PD-1 Antibody Plus Bevacizumab

Xinming Zhao, Hong Zhao, Yi Yang, 2022, Frontiers in Oncology.

FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma

Jiang Liu, L. Fashoyin-Aje, Martha Donoghue, 2020, Clinical Cancer Research.

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer

S. Khozin, P. Keegan, R. Pazdur, 2016, Clinical Cancer Research.

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as single agents for first-line treatment of advanced/metastatic PD-L1 high NSCLC.

Jiang Liu, Martha Donoghue, R. Pazdur, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

Efficacy and safety of adjuvant EGFR-TKIs for resected non-small cell lung cancer: a systematic review and meta-analysis based on randomized control trials

Hong Zhao, Pengfei Zhao, B. Cao, 2022, BMC cancer.

Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response

Jiang Liu, P. Keegan, M. Chatterjee, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

U.S. Food and drug administration approval: rituximab in combination with fludarabine and cyclophosphamide for the treatment of patients with chronic lymphocytic leukemia.

P. Keegan, R. Pazdur, A. Khandelwal, 2011, The oncologist.

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab

P. Keegan, R. Pazdur, Hong Zhao, 2017, Clinical Cancer Research.

Evaluation of the potential for QT/QTc interval prolongation for therapeutic biotechnology products.

P. Keegan, Hong Zhao, B. Booth, 2014 .

The Combination of Exposure‐Response and Case‐Control Analyses in Regulatory Decision Making

C. Garnett, P. Keegan, J. Gobburu, 2013, Journal of clinical pharmacology.

FDA Approval Summary: Nivolumab with Ipilimumab and Chemotherapy for Metastatic Non–small Cell Lung Cancer, A Collaborative Project Orbis Review

Jiang Liu, R. Pazdur, K. Korsah, 2021, Clinical Cancer Research.

Clinical advancement of precision theranostics in prostate cancer

Kai Liu, Hong Zhao, Yongxiang Tang, 2023, Frontiers in Oncology.

Comparison of first-line chemotherapy based on irinotecan or other drugs to treat non-small cell lung cancer in stage IIIB/IV: a systematic review and meta-analysis

Dong Wang, Xue-qin Yang, Chongyi Li, 2015, BMC Cancer.

Approval : Alectinib for the Treatment of Metastatic ALK-Positive Non – Small Cell Lung Cancer Following

Huanyu Chen, P. Keegan, Amy McKee, 2016 .

Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer.

Richard Pazdur, Huanyu Chen, P. Keegan, 2013, The oncologist.

Model‐Informed Drug Development Approach to Expedite Approval: Case of Alectinib in First‐Line Anaplastic Lymphoma Kinase + Non‐Small Cell Lung Cancer

Jiang Liu, Hong Zhao, G. Blumenthal, 2019, Clinical pharmacology and therapeutics.

FDA Approval Summary: Sotorasib for KRAS G12C Mutated Metastatic NSCLC.

Jiang Liu, R. Pazdur, Hong Zhao, 2021, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Jiang Liu, Reena Philip, K. Goldberg, 2021, Clinical Cancer Research.

AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development

Steven W. Martin, Shiew-Mei Huang, R. Evers, 2011, The AAPS Journal.

Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response

Manash S. Chatterjee, Jiang Liu, P. Keegan, 2017, Journal of Pharmacokinetics and Pharmacodynamics.

FDA Approval Summary: Amivantamab for the Treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.

Jiang Liu, Jielin Sun, Reena Philip, 2023, Clinical cancer research : an official journal of the American Association for Cancer Research.

Scientific Perspectives on Therapeutic Protein Drug–Drug Interaction Assessments

Shiew-Mei Huang, Lei Zhang, Hong Zhao, 2013 .

Phase II study of carboplatin combined with weekly docetaxel in patients with advanced non-small cell lung cancer

Zhi-Hua Zhu, Hong Zhao, Dao-yuan Wang, 2010, Cancer Chemotherapy and Pharmacology.

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

P. Keegan, R. Pazdur, A. Russell, 2013, Clinical Cancer Research.

FDA Approval Summary: Tremelimumab in combination with durvalumab for the treatment of patients with unresectable hepatocellular carcinoma.

L. Fashoyin-Aje, R. Pazdur, Hong Zhao, 2023, Clinical cancer research : an official journal of the American Association for Cancer Research.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma

Huanyu Chen, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma

P. Keegan, R. Pazdur, Hong Zhao, 2017, Clinical Cancer Research.